Product Catalogue. Diagnostics for the Determination of Autoantibodies, for Infectious Serology and Allergology

Transcription

1 Product Catalogue Diagnostics for the Determination of Autoantibodies, for Infectious Serology and Allergology Indirect Immunofluorescence ELISA RIA Westernblot EUROASSAY EUROLINE EUROPLUS

2 Table of Contents EUROIMMUN Company Profile... 4 Techniques for the Serological Investigation of Antibodies... 5 Indirect Immunofluorescence: An Easy and Modern Method... 6 BIOCHIP Mosaics... 9 The Indirect Immunofluorescence Test, Performed Using the TITERPLANE Technique Recommended Serum Dilutions for Indirect Immunofluorescence Diagnostically Relevant Systemic Autoantibodies Organ-/Tissue-Specific Autoantibodies Antibodies for Infectious Serology Antibodies for Allergology EUROIMMUN Microplate ELISA ELISA Automation using the EUROIMMUN Analyzer I Incubating the Microplate ELISA EUROASSAY: A New Technique for the Determination of Antibody Profiles Incubating the EUROASSAY (TITERPLANE Technique) The EUROLINE: A New Technique for Extensive Antibody Profiles Incubating the EUROLINE Westernblots/EUROLINE-WB: Reliable Differentiation of Antibodies Present Incubating the Westernblot/EUROLINE-WB EUROIMMUN Radioimmunoassays (RIA/IRMA) EUROIMMUN Products for the Determination of Autoantibodies Autoantibodies against Cell Nuclei (ANA) Autoantibodies against Double-Stranded DNA (dsdna) Autoantibodies against Cyclic Citrullinated Peptide (CCP) Autoantibodies against Mitochondria (AMA) Autoantibodies against Liver Antigens Autoantibodies against Thyroid Gland Antigens / Antigen Detections Autoantibodies against Neuronal Antigens Autoantibodies against Islet Cell Antigens Autoantibodies against Parietal Cells (PCA) Autoantibodies against Granulocyte Cytoplasm (canca/panca) Antibodies against Endomysium and Gliadin EUROIMMUN Products for Infectious Serology Antibodies against Borrelia/TBE Virus Antibodies against Epstein-Barr Virus (EBV) Antibodies against Helicobacter Pylori Antibodies against Herpes Simplex Virus (HSV) BIOCHIP Mosaics for Infectious Serology IgG Absorption in Preparation for the Determination of Specific IgM Class Antibodies EUROIMMUN Products for Allergology Order Information and Product Data Fluorescence-Labelled Antibodies: Fluorescein (FITC) for EUROIMMUN IIFT Controls for EUROIMMUN IIFT: Organ-Specific Autoantibodies Controls for EUROIMMUN IIFT: Systemic Autoantibodies Controls for EUROIMMUN IIFT: Infectious Serology Controls for EUROIMMUN IIFT: Determination of Further Antibodies Controls for EUROIMMUN Westernblots/EUROLINE-WB EUROASSAY for the Determination of Autoantibodies (Test Systems) EUROASSAY for Allergology (Test Systems) EUROLINE for the Determination of Autoantibodies (Test Systems) EUROLINE for Infectious Serology (Test Systems) EUROLINE for Allergology (Test Systems) Westernblot/EUROLINE-WB for the Determination of Autoantibodies (Test Systems) Westernblot/EUROLINE-WB for Infectious Serology (Test Systems) Microplate ELISA for the Determination of Autoantibodies (Test Systems) Radioimmunoassay (RIA) for the Determination of Autoantibodies / Autoantigens / Hormone Determination (Test Systems) Microplate ELISA for Infectious Serology (Test Systems) Microplate ELISA for the Determination of Antibodies against Other Antigens (Test Systems) Allercoat 6 System Diagnostics for Indirect Immunofluorescence: Organ-Specific Autoantibodies Diagnostics for Indirect Immunofluorescence: Systemic Autoantibodies Diagnostics for Indirect Immunofluorescence: Infectious Serology Diagnostics for Indirect Immunofluorescence: Other Antigens Further Reagents for EUROIMMUN IIFT Other Items for EUROIMMUN IIFT General Delivery Conditions Index

3 EUROIMMUN COMPANY PROFILE Company site Groß Grönau Company headquarters Lübeck Company branch Rennersdorf EUROIMMUN was founded in September 1987 and today has its headquarters in Lübeck, Germany. Branches are situated in Groß Grönau near Lübeck, in Rennersdorf (Upper Lusatia, Saxony) and in Pegnitz (Upper Franconia, Bavaria). Further EUROIMMUN subsidiaries can be found in Canada (Mississauga), China (Beijing, Hangzhou), Great Britain (Pontypool in Wales), Italy (Padua), Lebanon (Beirut), Poland (Wroclaw), Switzerland (Lucerne), Singapore, South Africa (Capetown), Turkey (Istanbul), the USA (New Jersey) and the United Arab Emirates (Dubai). At present EUROIMMUN has 500 employees in Germany, 630 worldwide. The company is ISO-certified (EN ISO 9001:2000, EN ISO 13485:2003, ISO 13485/ CMDCAS). EUROIMMUN produces reagents for medical laboratory diagnostics. In the foreground are test systems for the determination of various antibodies in patient serum in the diagnosis of autoimmune diseases, infectious diseases and allergies. The test methods employed are predominantly indirect immunofluorescence, microplate ELISA, various blot techniques (Westernblot, EUROASSAY, EUROLINE, EUROLINE-WB) and all molecular biology techniques. The company is based on worldwide-patented state-of-the-art production methods and microanalysis techniques and is one of the world s leading manufacturers of medical laboratory diagnostics. The BIOCHIPs are one of EUROIMMUN s many inventions: paper-thin sheets of glass are coated with cells or tissue sections and then cut automatically into millimetre-sized fragments which are subsequently glued onto slides using a fully automated device. This BIOCHIP technology allows extreme miniaturization and standardization of immunbiochemical analyses. With BIOCHIP Mosaics made from 30 or more different organ sections, cell substrates or defined antigens (EUROPLUS ) only minimum incubation efforts are necessary to obtain a detailed antibody profile. In EUROIMMUN enzyme immunoassays (ELISA) defined antigens, purified using state-of-the-art biotechnological processes, are employed as the antigen substrate. Some of these antigens are synthesized in the company s molecular biology laboratories. EUROIMMUN ELISA are characterized by their excellent stability, simple handling and short incubation times, and they are ideal for automated use. All reagents are delivered ready-to-use and are exchangeable between different lots. EUROIMMUN offers the largest and most differentiated arsenal of enzyme immunoassays worldwide for the diagnosis of autoimmune and infectious diseases. The innovative procedures EUROASSAY and EUROLINE developed by EUROIMMUN follow the same test principle as the ELISA methods, with the use of the BIOCHIP technology. At EUROIMMUN purified antigens are printed in parallel lines at defined positions on membrane strips. Following incubation, users can evaluate results visually without additional equipment. These reagents allow in particular the differentiation of antibodies that are not clearly defined microscopically by indirect immunofluorescence. EUROASSAY and EUROLINE are also employed in laboratories where no sophisticated laboratory instruments are available. 3

4 EUROIMMUN produces an extensive range of Westernblot strip test systems and corresponding reagents for confirmation of positive fluorescence and ELISA results as well as clarification of difficult-to-interpret results in autoimmune diagnostics, infectious serology and allergology. Refined electrophoretical processes have been developed to allow the precise separation of diagnostically relevant proteins from one another. Lot-specific evaluation templates are produced for the evaluation of band patterns. The program EUROLineScan enables computer-based evaluation and simplifies the archiving of results with large sample series. One of the company s main strengths is its technical expertise. This encompasses not just the manufacture and sale of medical laboratory diagnostics, but also the diagnostic application of the products in a reference laboratory which provides highly differential diagnostics. This reference laboratory has set standards in Germany, and worldwide is unequalled in the whole field of autoimmune diagnostics. The diagnostic spectrum of the laboratory also covers the areas of infectious serology and serological allergy diagnostics. The reference laboratory receives hundreds of serum samples daily from all over Germany as well as from many other countries. It helps EUROIMMUN customers to secure their results: a large proportion of serum samples sent to EUROIMMUN for evaluation are analysed free of charge in order to maintain high standards in the laboratories of EUROIMMUN customers. Customers can obtain further technical information from experienced scientists in the company, with whom they can also discuss serological problem cases. The Institute for Quality Assurance, an institution newly founded by EUROIMMUN, organises unbiased quality assessments and provides advice in the area of quality management. Moreover EUROIMMUN has established the Institute for experimental Immunology, which is engaged in basic research. In October 2007, the EUROIMMUN workforce included 92 university and college graduates, among these biologists, biochemists, chemists, engineers and medical doctors (26 of them holding a doctor s degree). Medical technicians are particularly strongly represented with 95 people, corresponding to EUROIMMUN s activities, as well as biology/chemistry laboratory technicians (44). At present the company is training 37 young people as biology laboratory assistants, industrial clerks, IT specialists, electronic system technicians, electronic technicians for devices and systems and industrial mechanics. At EUROIMMUN great value is placed on advising customers and prospective customers in a factual, technical and commercially restrained manner and fully supporting them in the use of our diagnostically demanding products. EUROIMMUN products are backed by an energetic and competent sales force, qualified information material, didactic test instructions and scientifically based, but nevertheless understandable advertisements in technical journals. Advertising material is produced in-house using the latest desktop publishing methods, right up until the fully digitalised ready-for-exposure documents. The most important publications and posters are translated into many languages. EUROIMMUN has set up an informative homepage on the internet ( which is visited extensively internationally. Over 3,000 laboratories worldwide use EUROIMMUN diagnostics: 400 of these are in Germany and the rest are found in countries including, among others, Algeria, Australia, Austria, Bangladesh, Belgium, Bosnia- Herzegovina, Brazil, Bulgaria, Canada, China, Croatia, Cyprus, the Czech Republic, Denmark, Egypt, Estonia, Finland, France, Great Britain, Greece, Hongkong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, the Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Qatar, Russia, Saudi-Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, Spain, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, the Ukraina, the United Arab Emirates, USA, Venezuela, Yemen. The company s development is shaped by continuous growth. Although the diagnostic market in Germany stagnated and has become particularly strongly competitive, EUROIMMUN has been able to continue its strong expansion. The company is achieving an ever increasing independence from the German market, since more and more products are sold abroad. With their quality and standardization, EUROIMMUN products are capturing the leading position in the world. 4

5 Techniques for the Serological Investigation of Antibodies TECHNIQUES FOR THE SEROLOGICAL INVESTIGATION OF ANTIBODIES 5

6 Techniques for the Serological Investigation of Antibodies cell with antigen specific human antibody Indirect Immunofluorescence: An Easy and Modern Method FITC Principle of the Test For the determination of autoantibodies or antibodies against infectious agents, cells, tissue sections or purified, biochemically characterized substances are used as antigen substrates. If the sample is positive, specific antibodies in the diluted serum sample attach to the antigens coupled to a solid phase. In a second step, the attached antibodies are stained with fluorescein-labelled anti-human antibodies and visualized with the fluorescence microscope. Positive samples can be titrated in steps. The most suitable titration interval is provided by the dilution factor (square root of 10). In this way, every second step represents in its denominator an integral power of 10 (1 : 10, 1 : 32, 1 : 100, 1 : 320, 1 : 1000, 1 : 3200, 1 : etc.). FITC-labelled antihuman antibody FITC Pattern homog. AntidsDNA? Anti-Histones? Pattern fine-granular. Anti-SS-A? Anti-SS-B? Indirect Immunofluorescence: A Standardized Technique for the Determination of Autoantibodies and Antibodies against Infectious Agents High specificity: positive and negative samples produce a large difference in signal strength. Each bound antibody shows a typical fluorescence pattern depending on the location of the individual antigens. The entire antigen spectrum of the original subtrate is available, thus allowing the detection of a large number of antibodies and achieving a higher detection rate. Immunofluorescence enables simultaneous detection of antibodies against several biochemically different antigens on one single biological substrate. The indirect immunofluorescence test is the analytical method of choice when it would be too difficult or too complicated to prepare the test antigens individually for enzyme immunoassays. Pattern nucleolar. Anti- Pattern cytoplasmic. PM-Scl? AMA M2? Differentiation of antibodies using HEp-2 cells. EUROIMMUN s Innovations for the Standardization and Modernization of Indirect Immunofluorescence BIOCHIP Technology and Mosaics. Activation technique: physically or chemically activated cover glasses are coated with cultured cells or tissue sections. Frozen tissue sections are fixed to the glass surface by covalent bonding, increasing adhesion more than 100 times and thus preventing the substrates from being detached. BIOCHIP Technology: cover glasses coated with biological substrates are cut into millimetre-sized fragments (BIOCHIPs) on a machine. This makes it possible to obtain ten or more first-class preparations of homogeneous quality per tissue section, in the case of cultured cell substrates even several thousands. BIOCHIP Mosaics : using several BIOCHIPs coated with different substrates side by side on one and the same reaction field, antibodies against various organs or infectious agents can be investigated simultaneously. Detailed antibody profiles can thus be established with comparatively little effort, allowing the reciprocal determination of the results on different substrates. TITERPLANE Technique: samples or reagents are applied to the reaction fields of a reagent tray. The BIOCHIP Slides are then placed into the recesses of the reagent tray, where all BIOCHIPs come into contact with the fluids, and the individual reactions commence simultaneously. As the fluids are confined in a closed space, there is no need for the use of a conventional humidity chamber. 6

7 Indirect Immunofluorescence: An Easy and Modern Method Chemically Activated Slides for Histochemistry For diagnostics of organ-specific or tissue-specific autoantibodies frozen tissue sections of various organs are used. However, formerly, the morphology of tissues suffered during incubation in aqueous medium, tissue parts occasionally became detached from slides, and the interpretation of results was difficult. Using the activation technique for the first time in histology, we have applied solid phase techniques. Firstly, the surface of cover glasses is coated with spontaneously reactive aldehyde groups. In a second step, the tissue sections are applied to the chemically activated cover glasses (Stöcker, W: European Patent No ; U.S. Patent No. 4,647,543). Free amino groups of the tissue sections, especially of the hydroxylysine contained in the collagen, bind to the carrier material by covalent bonding. This results in an increased adhesion of frozen tissue sections more than a hundredfold and prevents them from being detached during incubation. Furthermore, in some cases the activation technique results in a significantly better conservation of tissue structures, especially in organs which previously exhibited a generally low level of adhesion. Therefore, the tests can be evaluated with considerably greater confidence. Aminoethylaminoproyltrimethoxysilane H 3CO NH 2 (CH 2) 2 NH (CH 2) 3 Si OCH 3 OH glass OCH 3 glutardialdehyde HC (CH 2) 3 HC NH 2 N - 3 CH 3OH - H 2O - H 2O (CH 2) 2 NH (CH 2) 3 Si O O O O frozen tissue section frozen tissue section Fixation of frozen tissue sections to glass surfaces by covalent bonding. NH 2 HC (CH 2) 3 HC (CH 2) 2 NH (CH 2) 3 Si O O O N HC (CH 2) 3 HC N (CH 2) 2 NH (CH 2) 3 Si O O Techniques for the Serological Investigation of Antibodies Determination of Low-Avidity Antibodies An alternative principle for the serological diagnosis of fresh infections has been established by investigating the antibody avidity. The first reaction of the immune system following an infection is the formation of low-avidity antibodies. As the infection proceeds, increasingly antigen-adapted IgG is formed, and avidity grows. As long as high-avidity IgG is not yet detected in the serum, it can be assumed that the infection is still in an early stage. To identify low-avidity antibodies in a patient s serum, two immunofluorescence tests are performed in parallel: one test is carried out in the conventional way, the other one includes urea treatment between incubations with patient s serum and peroxidase-labelled anti-human IgG, resulting in the detachment of lowavidity antibodies from the antigens. Low-avidity antibodies are present if the fluorescence intensity is significantly reduced (two intensity levels ore more) by urea treatment. The following test kits for avidity determination are available: Toxoplasma gondii, Rubella virus, West-Nile virus, EBV-EA, EBV-CA. low-avide Ab against EBV-CA high-avide Ab against EBV-CA without urea with urea EUROPLUS System: Combination of conventional immunofluorescence substrates and monospecific tests In EUROPLUS immunofluorescence tests antibody detection is performed using both tissue sections/cell substrates and monospecifically reacting antigen dots. Antibodies detected in IFT screening tests can therefore be differentiated or confirmed with one and the same reaction field. In some cases, the antigen dots help to extend the antigen spectrum, offering a wider range for screening. BIOCHIPs coated with purified or recombinant antigens in droplet form are used as monospecific substrates. A positive result shows green circular areas of antigen dots in front of a dark background under the microscope. In some EUROPLUS test systems several different antigens are coated on one BIOCHIP in separate antigen rows. In this manner, several monospecific analyses can be performed using a single BIOCHIP. Many different BIOCHIP combinations for various diagnostic investigations are available. EUROPLUS : BIOCHIP combination of tissue sections/cell substrates (left) and antigen dots (right). 7

8 Techniques for the Serological Investigation of Antibodies Indirect Immunofluorescence: An Easy and Modern Method New: Hydrophobic Slides EUROIMMUN has developed a specific slide surface with hydrophobic properties. This prevents the droplets from spreading on the slide surface. The slides are now suitable for manual incubation using TITERPLANE Technique and nonmanual incubation on automated systems. The reaction fields must not be marked with a Cytomation Pen anymore. Price and order number are the same as for conventional EUROIMMUN slides (please add "hydrophobic" when ordering) Hydrophobic slides are available on request for many products. Above: conventional slide Below: hydrophobic slide. AP16/22 by DAS: Automated Solution for all EUROIMMUN Immunofluorescence Tests AP22 by DAS. Various validated parameters. Slide definitions and test files are provided on CD. CE conformity for device/test system combination. Capacity: 16 slides, 80 samples, 200 dilutions. Programmable for 8 methods per run. 10 dilution series freely programmable. Automated sample dilution, sample and reagent dispension, incubation and washing of slides. Laboratory software interface. The incubation protocol for result documentation is automatically created from the worklist. Barcode reader available on request. Fluorescence Microscope EUROStar II The EUROStar II is specifically tailored to the requirements of indirect immunofluorescence. Unnecessary and partly expensive components have been deliberately left out of the design and the conventional complex illumination fittings have been replaced by the stunningly simple EUROStar Bluelight system. With the EUROStar Bluelight, engineers at EUROIMMUN have introduced blue light-emitting diodes to fluorescence microscopy. Almost all the emitted light is suitable for the excitation of fluorescein. Only requiring a tenth of the electrical power (low heat formation) the EUROStar Bluelight dispenses the same amount of utilisable exciting light as a 50 watt HBO mercury lamp. The EUROStar Bluelight does not emit any ultraviolet radiation and is explosion proof. The large ballast and (interference-prone) inverter have been left out. The EUROStar Bluelight is immediately ready for operation after being switched off and offers instant full output after being switched on again. The LED shines for 15,000 hours which is 150 times longer than a mercury vapour lamp. Thus, the microscope requires almost no maintenance. Light flux electronically maintained at a constant level over the whole life span. A white LED light source for transmitted-light microscopy is available on request. 8

9 BIOCHIP Mosaics Techniques for the Serological Investigation of Antibodies For indirect immunofluorescence products, slides can be coated with individual substrates or BIOCHIP Mosaics consisting of up to 45 different substrates, depending on customers individual requirements and specifications. Thyroid gland, parathyroid gland, pancreas, adrenal gland, ovary, placenta*, testis, spermatozoa, pituitary gland, hypothalamus*, cerebrum, cerebellum, pons*, lobus temporalis, substantia nigra*, peripheral nerve, spinal cord, eye, granulocytes (fixed with ethanol or formaldehyde), lymphocytes, monocytes*, thrombocytes, kidney, lung*, liver, mouth mucosa*, stomach (corpus, antrum*), jejunum, colon, umbilical cord, mamma*, lacrimal gland*, parotid gland, prostate*, vesicula seminalis*, skeletal muscle, heart muscle, thymus*, lipocytes*, cartilage*, epidermis, oesophagus, tongue, lip*, melanocytes*, HEp-2 cells, HEp cells, HUVEC, rat kidney, mouse kidney, rat stomach, mouse stomach, rat liver, mouse liver, rat oesophagus, Crithidia luciliae etc. Adenovirus, Afipia felis*, Bartonella henselae, Bartonella quintana, Bordetella parapertussis, Bordetella pertussis, Borrelia afzelii, Borrelia burgdorferi (strains CH, USA), Borrelia garinii, Campylobacter coli*, Campylobacter jejuni*, Candida albicans, Candida glabrata*, Candida krusei*, Candida parapsilosis*, Candida tropicalis*, Chlamydia pneumoniae, Chlamydia trachomatis, Chlamydia psittaci*, CMV, Coxsackievirus (A7, A9, A16, A24, B1 to B6), EBV-CA, EBNA, EBV-EA, Echinococcus granulosus, ECHO virus, Haemophilus influenzae*, Helicobacter pylori, HIV-1*, HIV-2*, HHV-6, HSV-1, HSV-2, Influenza A (strains Shangdong, Singapore and Beijing), Influenza B (strain Panama), Klebsiella pneumoniae*, Legionella bozemanii*, Legionella dumoffii*, Legionella gormanii*, Legionella jordanis*, Legionella longbeachae, Legionella micdadei*, Legionella pneumophila (serotypes 1 to 14), Leishmania donovani, Listeria monocytogenes (1/2a and 4b)*, measles virus, mumps virus, Mycoplasma hominis, Mycoplasma pneumoniae, Parainfluenza 1 to 4, rubella virus, RSV, Saccharomyces cerevisiae, SARS-CoV, TBE virus, Toxoplasma gondii, Treponema pallidum, Treponema phagedenis, Ureaplasma urealyticum, VZV, West- Nile-Virus, Yersinia enterocolitica (O:3, O:4, O:6 and O:9)*. EUROPLUS : thyroid gland plus thyroglobulin, granulocytes (ANCA) plus MPO / PR3, HEp-2 cells (ANA) plus SS-A / SS-B / RNP/Sm / Sm / Scl-70 / Jo-1 / rib. P- prot., rat kidney plus AMA M2 / Sp100, primate stomach (parietal cells) plus intrinsic factor, small intestine (endomysium) plus gliadin, Borrelia plus VlsE/OspC. *) Currently not available as IVD in the EU. 9

10 Techniques for the Serological Investigation of Antibodies The Indirect Immunofluorescence Test, Performed Using the TITERPLANE Technique (Reaction fields 5 x 5 mm) The TITERPLANE Technique was developed by EUROIMMUN in order to standardize immunological analyses: Samples or labelled antibodies are applied to the reaction fields of a reagent tray. The BIOCHIP Slides are then placed into the recesses of the reagent tray, where all BIOCHIPs of the slide come into contact with the fluids, and the individual reactions commence simultaneously. Position and height of the droplets are exactly defined by the geometry of the system. As the fluids are confined in a closed space, there is no need for the use of a conventional humidity chamber. It is possible to incubate any number of samples next to each other and simultaneously under identical conditions. Prepare: Check the reagent tray: Are the reaction fields hydrophiiic and the surrounding coating hydrophobic? If not, rub with a wet paper towel, using normal household detergent or Extran MA 01 (Merck) if necessary, and rinse thoroughly with water. For occasional disinfection, immerse for 1 h in 3% Sekusept Extra (Henkel) in water. Open the individual packets containing the BIOCHIP Slides only after they have reached room temperature. Do not touch the BIOCHIPs. Mark BIOCHIP Slides as required with a felt pen. Dilute: Dilute serum samples according to the user s test protocol. Include positive and negative controls with every test procedure. Mix control sera before use. Pipette: Apply 25 µl of diluted serum to each reaction field of the reagent tray, avoiding air bubbles. Transfer all samples to be tested before starting the incubation (up to 200 droplets). Use a polystyrene pipetting template. Incubate: Start reactions by fitting the BIOCHIP Slides into the corresponding recesses of the reagent tray. Ensure that each sample makes contact with its BIOCHIP and that the individual samples do not come into contact with each other. Incubate for 30 min at room temperature. Wash: Rinse the BIOCHIP Slides with a flush of PBS-Tween using a beaker, and immerse them immediately afterwards in a cuvette containing PBS-Tween for at least 5 min. Pipette: Apply 20 µl of fluorescein-labelled anti human immunoglobulin (conjugate) onto each reaction field of a clean reagent tray. Add all drops (reagent for a maximum of 50 slides) before continuing incubation. Use a stepper pipette. The labelled anti-human serum should be mixed with a pipette before use. To save time, conjugate can be pipetted onto separate reagent trays during incubation with the diluted serum. Incubate: Remove one BIOCHIP Slide from the PBS-Tween and within five seconds blot only the back and the long edges with a paper towel and immediately put the BIOCHIP Slide into the recesses of the reagent tray. Do not dry the areas between the reaction fields. Check for correct contact between the BIOCHIPs and liquids. Then continue with the next BIOCHIP Slide. From now on, protect the slides from direct sunlight. Incubate for 30 min at room temperature. Wash: Rinse the BIOCHIP Slides with a flush of PBS-Tween using a beaker and put them in a cuvette containing PBS-Tween for at least 5 min. 10 drops of Evans Blue (150 µl) for each 150 ml phosphate buffer can be added for counterstaining. Embed: Place glycerol/pbs onto a cover glass drops of 10 µl per reaction field. Use a polystyrene embedding template. Remove one BIOCHIP Slide from the PBS-Tween and dry the back and all four edges as well as the surface around, but not between, the reaction fields with a paper towel. Put the BIOCHIP Slide, with the BIOCHIPs facing downwards, onto the prepared cover glass. Check immediately that the cover glass is properly fitted into the recesses of the slide. Correct the position if necessary. Now proceed in the same way with the next BIOCHIP Slide. Evaluate: Read the fluorescence under the microscope. 10

11 The Indirect Immunofluorescence Test, Performed Using the TITERPLANE Technique slide BIOCHIPs reagent tray Techniques for the Serological Investigation of Antibodies Pipette: 10 µl per field (3 x 3 mm) 25 µl per field (5 x 5 mm) 70 µl per field (7 x 9 mm) ;;;;;; diluted samples Incubate: 30 min Wash: 1 s flush 5 min cuvette PBS- Tween Pipette: 10 µl per field (3 x 3 mm) 20 µl per field (5 x 5 mm) 60 µl per field (7 x 9 mm) ;; ; ;; ; ;; ; ;; ; ;; ; ; labelled ; ; antibody ; ; Incubate: 30 min ;;;;;;;;;; Wash: 1 s flush 5 min cuvette PBS- Tween Embed: 10 µl per field (3 x 3 mm) 10 µl per field (5 x 5 mm) 20 µl per field (7 x 9 mm) glycerol/pbs cover glass Evaluate: fluorescence microscopy 20x NEOFLUAR 11

12 Techniques for the Serological Investigation of Antibodies Recommended Serum Dilutions for Indirect Immunofluorescence Autoimmunity Antibodies against Substrate IgA IgG IgM IgM acetylcholine receptor *skeletal muscle, monkey / heart, monkey 100 actin Hepatitis Mosaic** ADH-producing cells nucl. supraopticus & paraventricularis, monkey adrenal cortex adrenal gland, monkey 10 alveolar basement membrane lung, monkey / kidney, monkey 10 asialoglycoprotein receptors *Hepatitis Mosaic** 100 basic myelin protein (BMP) cerebellum, monkey / nerves, monkey / intestinal tissue, fetal monkey bile canaliculi Hepatitis Mosaic** bile duct epithelium Hepatitis Mosaic** brain: grey matter cerebellum, monkey / intestinal tissue, fetal monkey brain: white matter cerebellum, monkey / intestinal tissue, fetal monkey canca granulocytes (EOH), human / liver, monkey cartilage trachea, fetal monkey cell nuclei (ANA) HEp-2 cells / liver, monkey CENP-F *HEp-2 cells / liver, monkey centromere HEp-2 cells / liver, monkey cerebrum gyrus precentralis, monkey chondroitin sulfate trachea / cartilage, monkey collagen type VII oesophagus, monkey or tongue, monkey collagenous connective tissue pancreas, monkey colon (epithelial cells) intestinal tissue, fetal monkey cornea eye, monkey cyclin I (PCNA) HEp-2 cells / liver, monkey cyclin II (mitosin) HEp-2 cells / liver, monkey cytoskeleton HEp-2 cells / liver, monkey desmosomes oesophagus, monkey or tongue, monkey 10 dsdna *HEp-2 cells / liver, monkey dsdna Crithidia luciliae elastin stomach, rat / kidney, rat 10 endocardium endocardium, monkey / intestinal tissue, fetal monkey 10 endomysium liver, monkey endoplasmatic reticulum HEp-2 cells / liver, monkey endothelial cells lung, monkey endplates *skeletal muscle, monkey / heart, monkey 100 enterocytes intestinal tissue, fetal monkey eosinophilic granulocytes granulocytes (EOH) / liver, monkey epidermal basement membrane oesophagus, monkey or tongue, monkey eye muscle eye, monkey 10 fibrillarin (U3-nRNP) HEp-2 cells / liver, monkey filaggrin oesophagus, rat ganglion cells ganglion stellatum, monkey / intestinal tissue, fetal monkey gastric mucosa stomach, monkey 10 gastrin-producing cells stomach (antrum), monkey / stomach (corpus), monkey glandula suprarenalis adrenal gland, monkey 10 gliadin *intestinal tissue, fetal monkey / gliadin dots glomerular basement membrane (GBM) kidney, monkey glutamic acid decarboxylase (GAD) cerebellum, monkey / pancreas, monkey goblet cells goblet cells (culture) Golgi apparatus HEp-2 cells / liver, monkey hair follicle epidermis, monkey heart muscle skeletal muscle, monkey / heart, monkey heart valves mitral valve, monkey histones *HEp-2 cells / liver, monkey Hu cerebellum, monkey / nerves, monkey / intestinal tissue, fetal monkey hypothalamus nucl. supraopticus & paraventricularis, monkey *) In addition to the preferential analysis or as a plausibility check. **) Hepatitis Mosaic: liver, monkey / heart, monkey / HEp-2 cells / liver, rat / kidney, rat / stomach, rat. 12

13 Recommended Serum Dilutions for Indirect Immunofluorescence Autoimmunity Antibodies against Substrate IgA IgG IgM IgM inner ear inner ear, rat or guinea pig intercalated discs heart, monkey intestinal epithelial tissue intestinal tissue, fetal monkey intrinsic factor *stomach, monkey / intrinsic factor Jo-1 *HEp-2 cells / liver, monkey Techniques for the Serological Investigation of Antibodies keratin oesophagus, monkey or tongue, monkey keratin, RA-associated (filaggrin) oesophagus, rat Ku *HEp-2 cells / liver, monkey labyrinth inner ear, rat or guinea pig lacrimal gland (excretory ducts and acini) lacrimal gland, monkey laminin epidermis, monkey / lung, monkey / kidney, monkey lamins HEp-2 cells / liver, monkey lipocytes fat tissue, monkey liver membrane (LMA) Hepatitis Mosaic** 100 liver-kidney microsomes (LKM) Hepatitis Mosaic** 100 liver-pancreas antigen (LP) Hepatitis Mosaic** / pancreas, monkey 100 liver-specific protein (LSP) Hepatitis Mosaic** 100 lymphocytes Lymphocytes lysosomes HEp-2 cells / liver, monkey M2 *Hepatitis Mosaic** M3 *Hepatitis Mosaic** M4 *Hepatitis Mosaic** M5 *Hepatitis Mosaic** M6 *Hepatitis Mosaic** M7 *Hepatitis Mosaic** M8 *Hepatitis Mosaic** M9 *Hepatitis Mosaic** medullated nerves cerebellum, monkey / nerves, monkey melanocytes retina, monkey Mi-1 HEp-2 cells / liver, monkey Mi-2 HEp-2 cells / liver, monkey mitochondria (AMA) kidney, rat / stomach, rat / M2 dots / HEp-2 cells mouth mucosa mouth mucosa myelin cerebellum, monkey / nerves, monkey myelin-associated glycoprotein (M) cerebellum, monkey / nerves, monkey myeloperoxidase (MPO) granulocytes (EOH), human / liver, monkey myocardium skeletal muscle, monkey / heart, monkey myolemma skeletal muscle, monkey / heart, monkey myosin skeletal muscle, monkey / heart, monkey native collagen pancreas, monkey 10 nerves cerebellum, monkey / nerves, monkey / intestinal tissue, fetal monkey neuroendothelium cerebellum, monkey / nerves, monkey / intestinal tissue, fetal monkey neurofilaments cerebellum, monkey / nerves, monkey / intestinal tissue, fetal monkey NOR HEp-2 cells / liver, monkey nrnp HEp-2 cells / liver, monkey ovary ovary, monkey panca granulocytes (EOH), human / liver, monkey pancreas acini (Crohn s disease autoantigen) pancreas, monkey pancreas islets pancreas, monkey (1st step: 18 hours) pancreas, excretory duct epithelium pancreas, monkey parathyroid gland parathyroid gland, monkey parietal cells stomach (corpus), monkey parotid gland parotid gland, monkey peripheral nerves cerebellum, monkey / nerves, monkey / intestinal tissue, fetal monkey pituitary gland, anterior lobe pituitary gland, monkey *) In addition to the preferential analysis or as a plausibility check. **) Hepatitis Mosaic: liver, monkey / heart, monkey / HEp-2 cells / liver, rat / kidney, rat / stomach, rat. 13

14 Techniques for the Serological Investigation of Antibodies Recommended Serum Dilutions for Indirect Immunofluorescence Autoimmunity Antibodies against Substrate IgA IgG IgM IgM placenta placenta, human 10 PM-1 HEp-2 cells / liver, monkey proinsulin *pancreas, monkey prostate prostate, monkey 10 proteinase 3 (PR3) granulocytes (EOH), human / liver, monkey Purkinje cell cytoplasm (Yo) cerebellum, monkey RANA Raji cells / HEp-2 cells reticulin intestinal tissue, fetal monkey reticulocytes bone marrow, monkey retina retina, monkey Ri cerebellum, monkey / nerves, monkey / intestinal tissue, fetal monkey ribosomal P-proteins HEp-2 cells / liver, monkey ribosomes HEp-2 cells / liver, monkey RNA polymerase HEp-2 cells / liver, monkey RNA HEp-2 cells / liver, monkey salivary glands (acini and excretory ducts) parotid gland, monkey sarcolemma skeletal muscle, monkey / heart, monkey Scl-70 HEp-2 cells / liver, monkey signal recognition particle (SRP) HEp-2 cells / liver, monkey skeletal muscle skeletal muscle, monkey / heart, monkey Sm HEp-2 cells / liver, monkey smooth muscles (ASMA) stomach, rat / kidney, rat spermatozoa spermatozoa smear, human spindle fibers HEp-2 cells / liver, monkey spleen spleen, monkey SS-A (Ro) *HEp-2 cells / liver, monkey SS-B (La) *HEp-2 cells / liver, monkey ssdna *HEp-2 cells / liver, monkey striated muscles skeletal muscle, monkey / heart, monkey substantia nigra substantia nigra, monkey synovialis joint cartilage, monkey testis testis, monkey thrombocytes (bound antibodies) thrombocyte smear thrombocytes (free antibodies) thrombocytes, human thymus thymus, monkey thyroglobulin thyroid gland, monkey or struma, human/tg thyroid colloid type II thyroid gland, monkey or struma, human thyroid microsomes thyroid gland, monkey or struma, human trachea trachea, monkey tubular basement membrane kidney, monkey U1-nRNP *HEp-2 cells / liver, monkey vasopressin-producing cells nucl. supraopticus & paraventricularis, monkey vestibular organ inner ear, rat or guinea pig vimentin *HEp-2 cells / liver, monkey xanca granulocytes (EOH, acetone, HCHO) / liver, monkey *) In addition to the preferential analysis or as a plausibility check. **) Hepatitis Mosaic: liver, monkey / heart, monkey / HEp-2 cells / liver, rat / kidney, rat / stomach, rat. 14

15 Recommended Serum Dilutions for Indirect Immunofluorescence Infectious Serology Antibodies against IgA IgG IgM Adenovirus (type 3) Afipia felis Bartonella henselae Bartonella quintana Bordetella parapertussis Bordetella pertussis Borrelia afzelii Borrelia burgdorferi sensu stricto (strains CH and USA) Borrelia garinii Borrelia OspC 10 Techniques for the Serological Investigation of Antibodies Borrelia VlsE 100 Campylobacter coli Campylobacter jejuni Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis Chlamydia pneumoniae Chlamydia trachomatis CMV Coxsackie virus types A7, A9, A16, A24, B1 to B Dengue virus EBV-CA, EBV-EA EBNA Echinococcus granulosus Echo virus (type 7, 19) Haemophilus influenzae Helicobacter pylori HIV HIV HHV HSV HSV Influenza virus type A Influenza virus type B Klebsiella pneumoniae Legionella pneumophila (all serotypes) Leishmania Listeria monocytogenes (types 1/2a, 4b) measles virus mumps virus Mycoplasma hominis Mycoplasma pneumoniae Parainfluenza virus types rubella virus RSV Saccharomyces cerevisiae TBE virus Toxoplasma gondii Treponema pallidum Ureaplasma urealyticum VZV West-Nile virus Yersinia enterocolitica O:3; O:4; O:6; O:

16 Diagnostically Relevant Systemic Autoantibodies Techniques for the Serological Investigation of Antibodies Ig- M A G M BASIC SPECTRUM 151 cell nuclei (ANA: IF global testing) 152 ANA profile (differentiation) 1572 dsdns-ncx ELISA 1572 dsdna (dsdna): IF (SLE specific) 1590 ENA ProfilePlus ELISA 1 (nrnp/sm, Sm, SS-A, SS-B, Scl-70, Jo-1) 1590 ENA ProfilePlus ELISA 2 (rib. P protein, nrnp/sm, Sm, SS-A, SS-B, Scl-70, Jo-1, CENP B) 1590 SLE Profile ELISA (dsdna, histones, rib. P prot., nrnp/sm, Sm, SS-A, SS-B, Scl-70) 162 mitochondria (AMA) 171 smooth muscle (ASMA) 120 granulocytes: canca (M. Wegener)* 121 granulocytes: panca* 1010 autoantibody profile (10 IF substrates) 1030 autoantibody profile (30 IF substrates) Ig- M A G M SHARP SYNDROME (MCTD) 151 cell nuclei (ANA: IF global testing) 1576 single-stranded DNA (ssdna) 1591 U1-nRNP Ig- M A G M OTHER AUTOANTIBODIES 1612 centrioles 1613 spindle fibres (MSA-1) 1614 midbody (MSA-2) 1615 chromosome-associated antigen (MSA-3) 1617 centromere F protein (CENP-F) 1641 ribosomes 1642 Golgi apparatus 1643 lysosomes 165 cytoskeleton 1651 actin 1652 vimentin 1653 cytokeratin 1654 tropomyosin 1655 vinculin 1656 desmin 1659 laminin (basement membranes) IMMUNOGLOBULINS: Ig- M A G M ANTI human IgA 1813 human IgE 1814 human IgG (rheumatoid factor) 1815 human IgM CIRCULATING IMMUNE COMPLEXES 1818 C1q binding test**, *** Ig- M A G M SLE: CHRONIC COLLENOSIS 151 cell nuclei (ANA: IF global testing) 156 histones (global testing) 1560 histone profile 1572 dsdns-ncx ELISA 1572 dsdna (dsdna): IF (SLE specific) 1574 nucleosomes (SLE specific) 1576 single-stranded DNA (ssdna) 1582 U3-nRNP (fibrillarin) 1583 RNA polymerase I 1584 PM-Scl (PM-1) RNP (To) S-RNA 1587 nucleolus organizer region (NOR) 159 ENA Pool ELISA 1591 U1-nRNP 1593 Sm (SLE specific) 1595 SS-A (Ro) 159s SS-A 52 kda: recombinant 159t SS-A 60 kda: recombinant 1597 SS-B (La) 1599 Scl-70 (DNA topoisomerase I) 1601 cyclin I (PCNA) 1603 Sp100 (nuclear dots: PBC) 1611 centromeres 1611 centromere B protein (recombinant) 1621 cardiolipin (AMA M1) 162a phosphatidylserine 1632 ß-2-glycoprotein lupus anticoagulant (plasma)** 1640 ribosomal P proteins (SLE specific) 194 collagen (global testing) 1947 collagen type VII 195 elastin 196 endothelial cells Ig- M A G M POLYMYOSITIS, DERMATOMYOSITIS 151 cell nuclei (ANA: IF global testing) 1530 EUROLINE Myositis Profile (Mi-2, Ku, PM-Scl, Jo-1, PL-7, PL-12, Ro-52) 1576 single-stranded DNA (ssdna) 1584 PM-Scl (PM-1) 1605 Ku 1606 Mi Mi signal recognition particle (SRP) 1661 Jo PL PL OJ 1665 EJ Ig- M A G M PROGRESSIVE SYSTEMIC SCLEROSIS 151 cell nuclei (ANA: IF global testing) 1599 Scl-70 (DNA topoisomerase I) 1611 centromeres 1611 centromere B protein (recombinant) 1582 U3-nRNP (fibrillarin) 1583 RNA polymerase I 1584 PM-Scl (PM-1) RNP (To) S-RNA 1587 nucleolus organizer region (NOR) Ig- M A G M (RHEUMATOID) ARTHRITIS 151 cell nuclei (ANA: IF global testing) 156 histones (global testing) 1576 single-stranded DNA (ssdna) 1589 Sa 1591 U1-nRNP 1604 RANA (rheumathoid arthritis nuclear antigen) 1814 human IgG (rheumatoid factor) 194 collagen (global testing) 1947 collagen type VII 121 granulocytes: panca* 1219 granulocyte nuclei (GS ANA) 148 cartilage 1505 cyclic citrullinated peptide (CCP) 1508 filaggrin (RA keratin) 1635 serotonin 1636 polymyalgia rheumatica factor (PMR) FURTHER RHEUMATOID RELEVANT Ig- M A G M ANALYSES 2011 anti-streptolysin 2012 anti-streptokinase 2013 anti-streptodornase 2014 anti-dpnase (anti-nadase) 2031 anti-staphylolysin 2034 anti-hyaluronidase 213 Borrelia burgdorferi 2171 Yersinia enterocolitica O: Chlamydia trachomatis 6311 CRP Ig- M A G M WESTERNBLOT ANA TEST 1520 ANA differentiation (PM-Scl, CENP A/B/C, Ku 86 and 72 kda, M2 74 kda, RNP 70 kda, RNP A/C, Sm B/B /D, SS-A 60 and 52 kda, SS-B 52, 47, 44 and 43 kda, ribosomal P protein P0/P1/P2, Scl-70, Jo-1) Grey boxes: standard analysis * ANCA diagnostics in acute cases within one hour, at any hour ** Use special procedure for taking sample(s) *** Send frozen sample(s) 16

17 Organ-/Tissue-Specific Autoantibodies Ig- M A G M AUTOANTIBODY PROFILE IF substrates (BIOCHIPs) Ig- M A G M THYROID GLAND 1011 thyroid microsomes (MAb) 1012 thyroid peroxidase 1013 thyroglobulin (TAb) 1014 thyroid colloid type II 1015 TSH receptors (TRAb) 1016 T 3 (antibodies against T 3 ) 1017 T 4 (antibodies against T 4 ) Ig- M A G M DIABETES MELLITUS 1021 pancreas islets 1022 glutamic acid decarboxylase 1023 tyrosine phosphatase (IA-2) 1024 insulin: human 1025 insulin receptors Ig- M A G M (POLY)ENDOCRINOPATHY 1011 thyroid microsomes (MAb) 1021 pancreas islets 104 parathyroid gland 1051 adrenal cortex 1052 adrenal medulla Hydroxylase 1061 ovary: theca cells 1062 ovary: corpus luteum 107 placenta 1081 testis: Leydig cells 1091 pituitary gland: anterior lobe 1092 pituitary gland: posterior lobe 110 hypothalamus VPC 1361 stomach: parietal cells 1361 parietal cells (H + /K + -ATPase; ELISA) Ig- M A G M INFERTILITY 1060 ovary: theca cells, corpus luteum, zona pellucida 107 placenta 1081 testis: Leydig cells 1086 spermatozoa 1091 pituitary gland: anterior lobe 1401 prostate 1621 cardiolipin (AMA M1) Ig- M A G M NERVOUS SYSTEM 1111 brain: grey matter (stiff-man synd.) 1022 glutamic acid decarboxylase GAD 1027 amphiphysin 1111 neuronal antigens EUROLINE (amphiphysin, CV2, PNMA2 (Ma-2), Ri, Yo, Hu) 1113 Yo (Purkinje cell cytoplasm; PuCA-1) 1114 Tr (Purkinje cell cytoplasm; PuCA-2) 1115 Ri (neurone nuclei) 1116 Hu (neurone nuclei) 1117 Ma (neurone nucleoli) 1119 CV2 (oligodendrocytes) 1121 myelin 1122 basic myelin protein (MBP) 1123 myelin-assoc. glycoprotein (M) 1124 myelin of peripheral nerves 1153 NMO-IgG (neuromyelitis optica) 1154 aquaporin neurofascin 1156 myelin-oligodendrocytes glycoprotein (MOG) 1126 neuroendothelium 1127 neurofilaments 1128 glial fibrillary acidic protein (GFAP) 1129 non-medullated nerves 1130 ganglioside profile (GM 1, GM 2, GM 3, GD 1a, GD 1b, GT 1b, GQ 1b ) 1621 cardiolipin (AMA M1) 162a phosphatidylserine 1142 phosphatidylcholine 1143 phosphatidylethanolamine 1144 phosphatidylinositol 1145 phosphatidylglycerine 1361 stomach: parietal cells 151 cell nuclei (ANA: global testing) 1572 dsdna (ndna): IF (SLE specific) 213 Borrelia burgd.: serum CSF Ig- M A G M M. WEGENER, VASCULITIS* 120 ANCA Profile ELISA (Proteinase 3, Myeloperoxidase, elastase, cathepsin G, BPI, lactoferrin) 120 granulocytes: canca (M. Wegener)* 1201 canca: proteinase 3 (PR3-hn-hr) 1202 BPI (CAP 57) 121 granulocytes: panca* 1211 panca: myeloperoxidase (MPO) 1212 panca: elastase 1213 panca: cathepsin G 1215 panca: lactoferrin 151 cell nuclei (ANA: global testing) 195 elastin 196 endothelial cells Ig- M A G M KIDNEY, LUNG 125 kidney (IF global testing) 1251 glomerular basement membrane (GBM) 1252 tubular basement membrane (TBM) 1271 alveolar basement membrane 120 granulocytes: canca* 121 granulocytes: panca* 151 cell nuclei (ANA: IF global testing) 1572 dsdna (dsdna): IF (SLE specific) Ig- M A G M EYE 1171 cornea 1172 retina 1173 lens oculi 1174 corpus ciliare 1175 eye muscles 1176 retro bulbar connective tissue 1177 tunica choroidea (chronic chorioretinitis) 1011 thyroid microsomes (MAb) 1119 CV2 (oligodendrocytes) 120 granulocytes: canca* 151 cell nuclei (ANA: IF global testing) Ig- M A G M IMMUNOHEMATOLOGY 1209 granulocyte membrane 1221 lymphocytes 1226 monocytes 1231 thrombocytes: indirect test (free Ab) 1232 thrombocytes: direct test (bound Ab)** 124 erythrocytes: global testing 1361 stomach: parietal cells 1361 parietal cells (H + /K + -ATPase; ELISA) 1362 intrinsic factor Ig- M A G M SKELETAL MUSCLE, THYMUS, HEART 143 skeletal muscle 1431 titin 1432 sarcolemma 1434 MuSK 1435 acetylcholine receptors 1436 myosin 1437 calcium channel (type N) 1438 calcium channel (type PQ) 144 thymus 146 heart muscle 1461 heart: striation 1462 heart: intercalated discs 1463 heart: myolemma 1627 AMA M7 (myocardium specific) Ig- M A G M LIPODYSTROPHY 147 lipocytes Ig- M A G M EPIDERMIS 1501 epidermis: desmosomes 1502 epidermis: basement membrane 1502 epidermis: BP180-4X 1503 urinary bladder: basement membrane 1504 melanocytes 1505 herpes gestationis factor 1509 epidermal keratin 1572 dsdna (dsdna): IF (SLE specific) 191 endomysium (GSE, M. Duhring) 3011 gliadin (GSE, M. Duhring) Ig- M A G M LIVER 130 liver (IF global testing, 6 BIOCHIPs) 130 EUROLINE Profile autoimmune liver diseases (AMA M2, 3E (BPO), Sp100, PML, gp210, LC-1, LKM-1, SLA/LP, Ro-52) 1301 liver specific protein (LSP) 1302 soluble liver antigen (SLA/LP) 1303 asialoglycoprotein receptors 1304 liver cell membrane antigen (LMA) 1305 bile ducts 1306 bile canniculi 1307 liver cytosol (LC-1) 132 liver kidney microsomes (LKM) 1321 LKM 1 ELISA 121 granulocytes: panca 151 cell nuclei (ANA: IF global testing) 1603 Sp100 (nuclear dots: PBC) 1608 nuclear membrane (lamin; GP210) 1609 few nuclear dots (Coilin; P80) 162 mitochondria (AMA) 1620 mitochondria (AMA: types M1 to M9) 1621 AMA M1 (cardiolipin) 1622 AMA M2-3E (PDH + BPO) 1624 AMA M4 (sulfite oxidase) 1627 AMA M7 (myocardium specific) 1629 AMA M9 (glycogen phosphorylase) 1651 F-actin 1653 cytokeratin 8/ smooth muscles (ASMA) Ig- M A G M STOMACH, INTESTINE 1361 stomach: parietal cells 1361 parietal cells (H + /K + -ATPase; ELISA) 1362 intrinsic factor 1366 stomach: gastrin (G) cells 135 mouth mucosa (M. Crohn, Behçet) 1391 pancreas acini (M. Crohn) 1392 pancreas secretion (M. Crohn) 2841 Saccharomyces cerevisiae (M. Crohn) 121 granulocytes: panca (UC) 138 intestinal mucosa 1381 intestinal goblet cells (UC) 1382 enterocytes (M. Crohn, UC) 191 endomysium (GSE, M. Duhring) 191 tissue transglutaminase (GSE, M. D.) 192 reticulin 3011 gliadin GAF-3X (GSE, M. Duhring) PANCREATITIS, SJÖGREN S Ig- M A G M SYNDROME, EXOCRINE GLANDS 139 exocrine pankreas 1391 pancreas acini 1393 pancreas excretory ducts 1401 prostate 1406 mamma 141 lacrimal gland 142 parotid gland 1421 parotid gland acini 1423 parotid gland excretory ducts 151 cell nuclei (ANA: IF global testing) 1576 single-stranded DNA (ssdna) 1595 SS-A (Ro) 1597 SS-B (La) 1604 RANA (rheum. arthritis nuclear antigen) Ig- M A G M ANTIBODIES AINST ANIMAL IgG 3811 human anti-mouse IgG (HAMA) ANTIGEN- AND HORMONE DETERMINATIONS 1013 thyroglobulin (TG) 1016 free triiodthyronin (FT3) 1017 free thyroxin (FT4) 1018 thyrotropin (TSH) 1019 calcitonin IMMUNOHISTOLOGY**,*** 4125 kidney 4143 skeletal muscle 4126 urinary bladder mucosa 4144 myocardium 4127 lung 4150 epidermis 4131 liver 4199 other stomach intestinal mucosa Techniques for the Serological Investigation of Antibodies

18 Antibodies for Infectious Serology Techniques for the Serological Investigation of Antibodies IFT ELISA W.-blot Ig- M A G M BACTERIA A-Z 219a Afipia felis* 219b Bartonella henselae 219d Bartonella quintana 2055 Bordetella parapertussis 2050 Bordetella pertussis 2131 Borrelia afzelii 2132 Borrelia burgdorferi sensu stricto (CH) 2133 Borrelia burgdorferi sensu stricto (USA) 2134 Borrelia garinii 2092 Campylobacter coli* 2091 Campylobacter jejuni* 2192 Chlamydia pneumoniae 2193 Chlamydia psittaci* 2191 Chlamydia trachomatis 2070 Haemophilus influenzae* 2080 Helicobacter pylori 2101 Klebsiella pneumoniae* 216a Legionella bozemanii* 2167 Legionella dumoffii* 2166 Legionella gormanii* 2165 Legionella jordanis* 2168 Legionella longbeachae 2169 Legionella micdadei* 2150 Legionella pneumophila Serotypes 1-14: Listeria monocytogenes* 1/2a 4b 2201 Mycoplasma hominis 2202 Mycoplasma pneumoniae 2111 Treponema pallidum 2205 Ureaplasma urealyticum 2170 Yersinia enterocolitica* O:3 O:4 O:6 O:9 Respiratory tract Exanthem Lymphadenitis CNS Myocarditis Infectious arthritis Gastrointestinal tract Associated hepatitis Ophthalmology Otitis STD Pregnancy IFT ELISA W.-blot Ig- M A G M VIRUSES A-Z 2680 Adenovirus type 3 293a Chikungunya virus 2730 Coxsackievirus type: B1 B2 B3 B4 B5 B6 A7 A9 A16 A Cytomegalovirus Avidity determination 266 Dengue virus type a Echovirus type EBV capsid Ag (EBV-CA) Avidity determination 2795 EBV early Ag (EBV-EA) 2793 EBV nuclear Ag (EBNA) 278 Hantavirus type Hantaan Puumala Seoul Sin Nombre Dobrava Saaremaa 2531 Herpes simplex 1 (HSV-1) 2532 Herpes simplex 2 (HSV-2) 2536 Hum. herpes 6 virus (HHV-6) 2691 Influenza virus type A H1N1 H3N Influenza virus type B 2610 Measles virus 2630 Mumps virus 2720 Parainfluenza virus type: Resp. syncytial virus (RSV) 2590 Rubella virus Avidity determination 2661 TBE virus 2650 Varicella-zoster virus Avidity determination 2662 West-Nile virus Avidity determination 2665 Yellow fever virus Respiratory tract Exanthem Lymphadenitis CNS Myocarditis Infectious arthritis Gastrointestinal tract Associated hepatitis Ophthalmology Otitis STD Pregnancy Ig- M A G M PARASITES A-Z 2320 Echinococcus granulosus 2231 Leishmania donovani 2410 Toxoplasma gondii Avidity determination Ig- M A G M FUNGI A-Z 286 Candida albicans glabrata* krusei* parapsilosis* tropicalis* 2841 Saccharomyces cerevisiae Grey: standard analyses *) Currently not available as IVD in the EC 18

19 Antibodies for Allergology GLOBAL TEST 3840 Determination of total IgE INHALATION 3110 Inhalation Profile 1 (gx, t3, w6, d1, e1, e2, m2) 3110 Inhalation Profile 2 (g1, g3, g6, g12, t2, t3, t4, t7, w1, w6, w9, d1, d2, e1, e2, e3, m1, m2, m3, m6) 3111 Pediatrics (g6, g12, t2, t3, t4, w6, w8, w9, d1, d2, e1, e2, e3, e6, e82, e84, m1, m2, m3, m6) 3120 gx Grass mix (g6/g12) 3121 g1 Sweet vernal grass 3123 g3 Cocksfoot 3126 g6 Timothy grass 3132 g12 Cultivated rye 3152 t2 Alder 3153 t3 Birch 3154 t4 Hazelnut 3157 t7 Oak 3201 w1 Common ragweed 3206 w6 Mugwort 3208 w8 Dandelion 3209 w9 Plantain 3241 d1 House dust mite 1 (Dermatophagoides pteronyssinus) 3242 d2 House dust mite 1 (Dermatophagoides farinae) 3261 e1 Cat 3262 e2 Dog 3263 e3 Horse 3266 e6 Guinea pig 3282 e82 Rabbit 3284 e84 Hamster 3321 m1 Penicillium notatum 3322 m2 Cladosporium herbarum 3323 m3 Aspergillus fumigatus 3326 m6 Alternaria alternata DOMESTIC ANIMALS 3260 Dom. Animal Profile (e1, e2, e3, e6, e82, e84, e71) 3261 e1 Cat 3262 e2 Dog 3263 e3 Horse 3266 e6 Guinea pig 3282 e82 Rabbit 3284 e84 Hamster 3271 e71 Mouse epithelium FOOD 3410 Food Profile 1 (f1, f2, f3, f4, f13, f14, f17) 3410 Food Profile 2 (f1, f75, f2, f45, f4, f5, f9, f14, f13, f17, f20, f49, f237, f84, f85, f31, f25, f35, f3, f23) 3421 f1 Egg white 3425 f75 Egg yolk 3442 f2 Milk 3531 f45 Yeast 3522 f4 Wheat flour 3523 f5 Rye flour 3527 f9 Rice 3544 f14 Soja bean 3543 f13 Peanut 3547 f17 Hazelnut 3550 f20 Almond 3569 f49 Apple 3596 f237 Apricot 3573 f84 Kiwi 3574 f85 Celery 3563 f31 Carrot 3562 f25 Tomato 3565 f35 Potato 3461 f3 Codfish 3462 f23 Crab INSECT VENOMS 3731 i1 Honey bee venom 3733 i3 Wasp venom LATEX AND LATEX-ASSOCIATED ALLERGIES 3760 Latex Plus (k82, k81, f92, f96, f35, f84) 3774 k82 Latex 3773 k81 Ficus spp f92 Banana 3582 f96 Avocado 3565 f35 Potato 3573 f84 Kiwi ATOPY 3710 Atopy Profile (g6, g12, t3, w6, e1, e2, e3, d1, m2, m6, f1, f2, f3, f4, f9, f14, f17, f31, f35, f49) 3126 g6 Timothy grass 3132 g12 Cultivated rye 3153 t3 Birch 3206 w6 Mugwort 3261 e1 Cat 3262 e2 Dog 3263 e3 Horse 3241 d1 House dust mite 1 (Derm. pteronyssinus) 3322 m2 Cladosporium herbarum 3326 m6 Alternaria alternata 3421 f1 Egg white 3442 f2 Milk 3461 f3 Codfish 3522 f4 Wheat flour 3527 f9 Rice 3544 f14 Soja bean 3547 f17 Hazelnut 3563 f31 Carrot 3565 f35 Potato 3569 f49 Apple POLLEN-ASSOCIATED FOOD ALLERGIES 3711 Profile Pollen-Food Cross Reactions (gx, t3, w6, f4, f5, f13, f17, f20, f48, f89, f271, f275, f44, f49, f348, f237, f328, f31, f35, f85) 3120 gx Grass mix (g6/g12) 3153 t3 Birch 3206 w6 Mugwort 3522 f4 Wheat 3523 f5 Rye 3543 f13 Peanut 3547 f17 Hazelnut 3550 f20 Almond 3568 f48 Onion 3672 f89 Mustard 3652 f271 Anise 3656 f275 Lovage 3566 f44 Strawberry 3569 f49 Apple 3629 f348 Lychee 3596 f237 Apricot 3624 f328 Fig 3563 f31 Carrot 3565 f35 Potato 3574 f85 Celery Techniques for the Serological Investigation of Antibodies Grey: standard analyses Allercoat 6 System: Antibodies of class IgE against 600 different allergens of the areas animal allergens, environmental allergens, food, grasses, herbal and flower pollen, house dust, insects, mites, moulds, parasites, pharmaceutical drugs, trees. 19

20 Techniques for the Serological Investigation of Antibodies POD-labelled anti-human antibody specific human antibody substrate POD POD antigen-coated microplate well EUROIMMUN Microplate ELISA stain chromogen Principle of the Test Polystyrene microplate strips coated with purified, biochemically characterized antigens are used as solid phase containing bound antigens. If the sample is positive, specific antibodies in the diluted serum sample attach to the antigens coupled to the solid phase. In a second step, the attached antibodies are detected with peroxidase-labelled anti-human antibodies. In a third step, the bound antibodies are made visible using a chromogen/ substrate solution which is capable of promoting a color reaction. The intensity of the color produced is proportional to the concentration of antibodies in the serum sample. Monospecific ELISA (enzyme immunoassays with a single antigen) provide a quantitative in vitro assay for the detection of antibodies. Profile ELISA provide a semiquantitative in vitro assay for the detection of different antibodies on a single microplate strip. The solid phase of Pool ELISA is coated with an antigen mixture for the semiquantitative detection of antibodies whose specificity must be subsequently investigated by monospecific assays. Reliable and Economical Calibration/Evaluation In the case of a quantitative ELISA, calibration is performed using three calibration sera. Calibration serum 1: upper limit of the measurement range Calibration serum 2: upper limit of the normal range (cut-off value) Calibration serum 3: negative Only three wells are required for calibration, followed by serum samples. There is no need to incubate blank values or duplicate determinations. Semiquantitative ELISA are performed using only one calibrator. The calibration is performed in relative units per milliliter (RU/ml) or, if an international reference serum exists, in international units per milliliter (IU/ml). Each test can be optionally performed using a positive or negative control serum included in the test kit. Kit-specific reference ranges are provided for each calibrator and control serum. All calibrations can be easily performed with the usual ELISA software. A B C D E F G H H. PYL. H. PYL. H. PYL. H. PYL. H. PYL. H. PYL. H. PYL. H. PYL. Easy, Quick and Economical Handling Microplate strips containing break-off wells (except Profile ELISA), each marked with an antigen abbreviation to avoid confusion of wells. Reagents ready for use (wash buffer: concentrate). Reagents are color-coded to ensure positive identification. dark red: calibration serum 1 orange: anti-human IgA POD-conj. red: calibration serum 2 green: anti-human IgG POD-conj. light red: calibration serum 3 red: anti-human IgM POD-conj. dark blue: pos. control serum turquoise: anti-human IgGM POD-conj. green: neg. control serum yellow: anti-human IgM POD-conj. light blue: sample buffer The sample buffer for infectious serology ELISA (detection of antibodies of class IgM) already contains an IgG/RF absorbent. Several tests can be combined on one and the same microplate, since the incubation times (30 min; 30 min; 15 min) are identical for all ELISA. Incubation at room temperature. Compatible with all commercial washer and reader systems. 20

21 Determination of Low-Avidity Antibodies EUROIMMUN Microplate ELISA An alternative principle for the serological diagnosis of fresh infections has been established by investigating the antibody avidity. The first reaction of the immune system following an infection is the formation of low-avidity antibodies. As the infection proceeds, increasingly antigen-adapted IgG is formed, and avidity grows. As long as high-avidity IgG is not yet detected in the serum, it can be assumed that the infection is still in an early stage. To identify low-avidity antibodies in a patient s serum, two microplate ELISA are performed in parallel: one test is carried out in the conventional way, the other one includes urea treatment between incubations with patient s serum and peroxidase-labelled anti-human IgG, resulting in the detachment of low-avidity antibodies from the antigens. Low-avidity antibodies are present if the ELISA extinction is significantly reduced by urea treatment. For an objective interpretation, the relative avidity index (RAI) can be calculated out of the measured values with and without urea incubation. Serum dilution 1 : 100, conjugate class anti-human IgG, POD-labelled. 3-point calibration, quantitative (IgG). The following test kits for avidity determination are available: Toxoplasma gondii, CMV, rubella virus, VZV, West-Nile virus, EBV-CA. Number of Patients RAI = E with urea E without urea Relative Avidity Index (RAI) in % Primary Infection Previous Infection Avidity of antibodies against EBV-CA (IgG) Techniques for the Serological Investigation of Antibodies Antibody Determination in CSF Indication: local infections of the brain. CSF dilution 1 : 2, serum dilution 1 : 401. Conjugate classes anti-human IgG or IgM, POD-labelled. Easy to conduct: ready-for-use reagents. 4-point calibration, quantitative. Identical incubation conditions and times (room temperature; 60 min / 60 min / 15 min): all EUROIMMUN ELISA for CSF diagnostics can be combined without difficulty on one and the same microplate. The antibody concentration in the patient s serum is determined in parallel to the antibody concentration in CSF on one and the same microplate. The CSF/serum quotient CSQ path.-spec. is calculated from both measured values. An intrathecal synthesis of specific antibodies is present if the CSF/serum quotient of the specific antibodies CSQ path.-spec. is significantly higher than the CSF/serum quotient of the whole IgG (CSQ total ) or if necessary the CSQ lim.. The relation of both values indicates the relative CSF/serum quotient CSQ rel. (synonym: antibody specificity index, ASI). Interpretation of results (according to the recommendations of Prof. Reiber): CSQ rel. < 1,3: standard range CSQ rel. 1,3 1,5: borderline range CSQ rel. > 1,5: Indication of pathogen-specific antibody production in the CNS For the automatic calculation of the CSQ rel. EUROIMMUN provides a specific Excel table free of charge. Highest sensitivity, specificity and reproducibility. Antibody concentrations in the serum and CSF are determined within the linear range of the test. The following test kits for CSF diagnostics are available: Borrelia burgdorferi, Toxoplasma gondii, HSV-1, HSV-2, HSV-1/2 Pool, CMV, rubella virus, measles virus, mumps virus, VZV, TBE, EBV-CA. All test systems for CSF diagnostics can also be used only for serology. Perfectly adapted for the automated incubation in incubation devices. A B C D E F G H CA-D ELISA incubation scheme Table-based evaluation of the CSQ rel. CSQ total CA C3 1:2 CB S3 1:401 CC C4 1:2 CD S4 1:401 C1 C5 1:2 1:2 S1 S5 1:401 1:40 1 C2 C6 1:2 1: 2 S2 S6 1:401 1:40 1 CSF calibrators CSF serum C S 80% 60% 40% 20% Reference range of normal values, intact blood-csf barrier Dysfunction of the blood-csf barrier, no Ig production in the CNS Dysfunction of the blood-csf barrier, additional Ig production in the CNS Intact blood-csf barrier, Ig production in the CNS Mistakes during preparation of the sera or the analytical steps CSQ alb. CFS/serum quotient diagram according to Reiber and Lange (1991) 21

22 Techniques for the Serological Investigation of Antibodies ELISA Automation Using the EUROIMMUN Analyzer I EUROIMMUN Analyzer I: The New Automated ELISA System for Microtiter Plates Automation of all EUROIMMUN ELISA, including the allergy system Allercoat 6. Over 900 validated parameters available (60 autoantibody, 100 infection and 650 allergy parameters). Up to 7 microtiter plates can be loaded. Unusually short loading time. Reloading function for patient samples, microtiter plates, reagents and disposable tips. "Walk-away function" fully automated from the start to the end of processing following loading. Own processor, independent of external system, minimises risk of system crashes. Bidirectional online connection to laboratory computer system. Modular System: A Highly Sophisticated Solution High convenience through barcode identification of samples and reagents: automatic scanning when racks are inserted, quality control certificate via 2D hand barcode scanner. Dilution area: 288 dilution positions (Deepwell, 2 ml). Liquid level detection (capacitive), multi-shot (dispensing) mode, automatic tip detection, clot detection. Pipetting possible during plate transport due to separation of transport and pipetting unit. 4 incubators with heating and shaking function, 4 incubators at room temperature. Standard Windows 2000 software available in several languages: open system, all relevant statistical functions included. Memory function for tips and dilution plates: allows full use of the dilution plates, no reloading of tips required. A Convincing and Reliable Package: EUROIMMUN Analyzer I, EUROIMMUN ELISA, EUROIMMUN Service approved approved Comprehensive test system validation for the EUROIMMUN Analyzer I: all parameters validated in accordance with the 98/79/EC directive and based on EN ISO 13485:2003. All ELISA test systems are manufactured according to the European Quality Standards (IVD). National and international conformity (standardisation): CE, IVD, FDA and CMD/CAS. Programming and setup of automated system, including introduction into the system and customer training, performed by qualified personnel. Reliable and fast delivery of disposable materials. Connection to in-house computer system via communication protocol ASTM. Maintenance contract with EUROIMMUN if desired. 22

23 Pipette: Incubating the Microplate ELISA 100 µl per well microplate wells coated with antigens diluted samples ; ;;;; Techniques for the Serological Investigation of Antibodies Incubate: 30 min ;; ;; ;;;;;;;; Wash: 300 µl wash buffer per well 3x Pipette: 100 µl per well enzyme conjugate ;; ; ;;;;;;; Incubate: 30 min ;;; ;;; ;;;;;;;;;;;;; Wash: 300 µl wash buffer per well 3x Pipette: 100 µl per well ; chromogen/ substrate solution Incubate: 15 min ;;;;;;; Pipette: 100 µl per ;; yy stop ;; ;; ;; ;; yy Evaluate: photometric measurement at a wavelength of 450 ;;; yyy ;; yy ;; ;; ;; yy 23

24 Techniques for the Serological Investigation of Antibodies EUROASSAY: A New Technique for the Determination of Antibody Profiles chromogen stain membrane coated with antigen specific human antibody AP AP substrate AP-labelled anti-human antibody Principle of the Test Membrane strips coated with thin parallel lines of several purified, biochemically characterized antigens are used as solid phase. The membrane strips are fixed as BIOCHIPs in the fields of microscope slides. If the sample is positive, specific antibodies in the diluted serum sample attach to the antigens coupled to the solid phase. In a second incubation step, the attached antibodies react with AP-labelled antihuman antibodies. In a third step, the bound antibodies are stained with a chromogen/substrate solution which is capable of promoting a color reaction. An intense dark band at the line of the corresponding antigen appears if the serum sample contains specific antibodies. The microscope slides are incubated using the TITERPLANE Technique: samples and reagents are applied to the reaction areas of a reagent tray. The slides are then placed into the recesses of the reagent tray, where all test strips of one slide come into contact with the liquids, and the individual reactions begin simultaneously. Depending on the spectrum of antigens used, it is possible to analyze several antibodies next to each other and simultaneously under identical conditions. Easy Handling Several serum samples can be analyzed simultaneously on one and the same slide. Total time for performing the EUROASSAY test is about 100 minutes. During the washing procedure, reagents for the next incubation step can be applied to reagent trays. All incubation steps proceed at room temperature. Shaking the slides together with the reagent tray on a circulatory shaker ensures the best possible sensitivity. Low reagent consumption. Only 50 µl each of diluted serum and reagent are needed per test field. Reagents ready for use (wash buffer: concentrate). nrnp/sm Sm SS-A SS-B Scl-70 Jo-1 Control band Reliable and Simple Evaluation Since results are evaluated visually, there is no investment required for photometers, etc. The antigen bands are located at exactly defined positions, which means that evaluation of the test is much simpler than for Westernblots. Correct completion of the individual incubation steps in each test field is indicated by staining of the control band. Positive and negative results can be easily and reliably differentiated from each other. The intensity of the antigen bands correlates with the antibody titer. The antigens used are highly pure, mostly isolated by affinity chromatography. The membrane strips do not contain any superfluous proteins which might cause unspecific positive results. The incubated microscope slides can be stored for long periods. Results can be easily documented. EUROASSAY Anti-ENA ProfilePlus: detection of antibodies against SS-A and SS-B in a case of Sjögren s syndrome. 24

25 Incubating the EUROASSAY (TITERPLANE Technique) slide membrane strips reagent tray Techniques for the Serological Investigation of Antibodies Pipette: 50 µl per field ;;;;;; diluted samples Incubate: 30 min shaking on a circulatory shaker (300 rpm) ;;;;;;; Wash: 5 s flush 15 min cuvette wash buffer Pipette: 50 µl per field ;; ; ;; ; ;; ; ;; ; ;; ; enzyme conjugate ; ; ; ; ; Incubate: 30 min shaking on a circulatory shaker (300 rpm) ; ; ; ; ; Wash: 5 s flush 15 min cuvette wash buffer Pipette: 50 µl per field ;;;;; chromogen/substrate ;;;;; solution Incubate: 10 min shaking on a circulatory shaker (300 rpm) ;;;;; Wash: flush with deionized or distilled water, air dry Evaluate: visual assessment of color intensity 25

26 Techniques for the Serological Investigation of Antibodies AP-labelled anti-human antibody specific human antibody The EUROLINE: A New Technique for Extensive Antibody Profiles substrate AP AP stain chromogen Principle of the Test Membrane strips coated with thin parallel lines of several purified, biochemically characterized antigens are used as solid phase. The membranes are fixed as BIOCHIPs onto synthetic foil. If the sample is positive, specific antibodies in the diluted serum sample attach to the antigens coupled to the solid phase. In a second incubation step, the attached antibodies react with alkalinephosphatase-labelled anti-human antibodies. In a third step, the bound antibodies are stained with a chromogen/substrate solution which is capable of promoting a color reaction. An intense dark band at the line of the corresponding antigen appears if the serum sample contains specific antibodies. Depending on the spectrum of antigens used, it is possible to analyze several antibodies next to each other and simultaneously under identical conditions. membrane coated with antigen Easy Handling, Reliable and Simple Evaluation nrnp/sm Sm SS-A/Ro-52 SS-B Scl-70 PM-Scl Jo-1 CENP B PCNA dsdna/nucleos. histones rib. P proteins AMA M2 A separate membrane strip is incubated for each serum sample. Total time for performing the analysis is about 105 minutes. The incubation can be automated. All incubation steps proceed at room temperature on a rocking platform. The required incubation tray is supplied in each test kit. Prior to first incubation step, the EUROLINE test strips are treated for 5 minutes with sample buffer*. The results are evaluated visually: no investment for photometers or other equipment is necessary. The antigen bands are located at exactly defined positions, which means that the evaluation of the test is much simpler than for Westernblots. Correct completion of the individual incubation steps is indicated by staining of the control band on each EUROLINE test strip. Positive and negative results can be easily and reliable differentiated from each other. The intensity of the antigen bands correlates with the antibody titer. The antigens used are highly pure, mostly isolated by affinity chomatography. The membrane strips do not contain any superfluous proteins which might cause unspecific positive results. The incubated EUROLINE test strips can be stored for long periods. Results can be easily documented. The program EUROLineScan from EUROIMMUN has been developed to enable quantitative evaluation of EUROLINE test strips, to facilitate management of data, and to provide detailed documentation of results. First, the incubated EUROLINE test strips are scanned using a flatbed scanner. EUROLineScan recognizes the position of the strips, even if they have been placed inexactly, identifies the bands, and measures their intensity. The results are then saved together with the image data. A separate results sheet can be produced for each patient. *) only applicable for some EUROLINE test kits control Incubated EUROLINE ANA-Profile 3 test strips. 26

27 Pipette: Incubating the EUROLINE EUROLINE test strip incubation channel sample buffer 1.5 ml per channel* Techniques for the Serological Investigation of Antibodies Incubate: 5 min shaking on a rocking platform* Aspirate off:* Pipette: 1.5 ml per channel ; diluted samples Incubate: Wash: Pipette: Incubate: Wash: Pipette: 30 min shaking on a rocking platform 1.5 ml buffer, 5 min incubation, aspirate off 1.5 ml per channel 30 min shaking on a rocking platform 1.5 ml buffer, 5 min incubation, aspirate off 1.5 ml per channel 3x 3x ; ;;;;; ;;;; ; ;; ; ; ; ;;;;;;;;;;;;;;;;;;;;;;;;;;;; ; wash buffer enzyme conjugate wash buffer chromogen/substrate solution Incubate: Wash: 10 min shaking on a rocking platform rinse with distilled water, aspirate off 3x ; ; Evaluate: visual assessment of bands *) only applicable for some EUROLINE test kits 27

28 Techniques for the Serological Investigation of Antibodies Westernblot/EUROLINE-WB: Reliable Differentiation of Antibodies Present AP-labelled anti-human antibody specific human antibody substrate AP AP membrane coated with antigen stain chromogen Principle of the Test Membrane strips containing electrophoretically separated antigen extracts are used as solid phase. The position of the proteins depends on their respective molecular weights. If the sample is positive, specific antibodies in the diluted serum sample attach to the antigens coupled to the membrane. In a second incubation step, the attached antibodies react with AP-labelled antihuman antibodies. In a third step, the bound antibodies are stained with a chromogen/substrate solution which is capable of promoting a color reaction. An intense dark band at the line of the corresponding antigen appears if the serum sample contains specific antibodies. Evaluating the band patterns on the incubated membrane strips involves differentiating non-specific from specific antibodies. The number and intensity of the specific bands is decisive for the result positive/negative. Antibodies against all antigens contained in the membrane strip can be analyzed simultaneously in one single test procedure. EUROLINE-WB Borrelia VlsE antigen on EURO- LINE membrane chip p 83 p 41, Flag. p 39, Bmp A p 31, Osp A p 30 p 25, Osp C p 21 p 19 p 17 Alignment bar Control band Reliable Evaluation and High Diagnostic Significance A separate membrane strip is incubated for each serum sample. Total time for performing the Westernblot test is about 115 minutes. The bands are assigned according to a lot-specific evaluation matrix provided. A separate lot is issued for each electrophoresis gel, helping to avoid errors in the assignment of the bands. Every test kit contains a membrane strip of the same lot incubated with a positive reference serum. Therefore, there is no need to incubate a positive control serum. The membrane strips are pre-numbered to prevent confusion. Laborious labelling is not necessary. Correct completion of the individual incubation steps for each membrane strip is indicated by staining of the control band at the bottom of the strip. EUROLINE-WB is a combination of westernblot and line blot techniques. Proteins from a whole antigen extract are electrophoretically separated according to molecular mass and transferred onto a nitrocellulose membrane. Highly purified native or recombinant antigens are then printed as lines onto the westernblot strips (EUROLINE membrane chip). EUROBlotCamera EUROBlotScanner Automatic evaluation of results using EUROLineScan For all EUROIMMUN blot systems: EUROLINE, EUROLINE-WB, Westernblot. For all areas: autoimmune diagnostics, infectious serology and allergy. EUROBlotCamera: digitalisation of strips while in the incubation tray. EUROBlotScanner: digitalisation of strips using flatbed scanner. Fully automated identification, quantitation and assignment of bands. Option to modify results (changes are automatically documented). Complete results obtained just a few minutes after finishing the incubation. Fully automated administration and documentation of extensive individual data. Electronic archiving of all images and data (avoids the need to store potentially infectious blot strips). 28

29 Incubating the Westernblot/EUROLINE-WB membrane strip incubation channel universal buffer Pipette: 1.5 ml per channel Techniques for the Serological Investigation of Antibodies Incubate: 15 min shaking on a rocking platform Aspirate off: Pipette: 1.5 ml per channel ; diluted samples Incubate: Wash: Pipette: Incubate: Wash: Pipette: 30 min shaking on a rocking platform 1.5 ml buffer, 5 min incubation, aspirate off 1.5 ml per channel 30 min shaking on a rocking platform 1.5 ml buffer, 5 min incubation, aspirate off 1.5 ml per channel 3x 3x ; ;;;;; ;;;; ; ;; ; ; ; ;;;;;;;;;;;;;;;;;;;;;;;;;;;; ; universal buffer enzyme conjugate universal buffer chromogen/substrate solution Incubate: 10 min shaking on a rocking platform ; ; Wash: rinse with distilled water, aspirate off Evaluate: visual assessment 29

30 Techniques for the Serological Investigation of Antibodies 125 I radioactively labelled antigen ( tracer ) EUROIMMUN Radioimmunoassays (RIA/IRMA) specific human antibody 125 I Test principle RIA (precipitation techniques) In the first incubation step patient sera are incubated with 125 I-labelled antigen in polystyrene tubes. Any specific antibodies in the sera bind to the antigen. In the second incubation step the antigen-antibody complexes are precipitated using a precipitation agent. The precipitate is washed with buffer. After centrifugation and decanting of the supernatant, the radioactivity in the precipitate is counted using a gamma counter. The intensity of the radioactivity is proportional to the concentration of specific antibody in the patient serum. The antibody concentration is evaluated quantitatively using a calibration curve. precipitation agent Test principle RIA (coated tubes) RIA tests (coated tubes) are competitive ligand assays for antibody and antigen determinations. The intensity of radioactive radiation is inversely proportional to the concentration of specific antibodies or antigens in the sample. The quantitative evaluation of the antigen/antibody concentration is carried out using a calibration curve. solid phase (tube surface) antibody radioactively labelled antibody analyte 125 I Test principle IRMA (antigen determination) With this test principle, monoclonal antibodies which are bound directly or indirectly to the inner wall of polystyrene tubes are used. During the first incubation step, the patient sera to be investigated are incubated with the monoclonal 125 I-labelled antibodies in the coated tubes. The antigen in the sample is bound by the immobilised antibodies and by the 125 I- labelled antibodies. This results in a solid-phase bound sandwich complex. The unbound 125 I-labelled antibodies are removed by washing and subsequently decanting. The intensity of radioactive radiation is proportional to the concentration of antigens in the patient serum. The quantitative evaluation of the antigen concentration is carried out using a calibration curve. Simple and economical handling, reliable analysis Simple test procedure. Synchronous processing of samples, including different tests in parallel. Ready-to-use reagents (possible exceptions: tracer, precipitation reagents). Different test formats for small and large sample series. Because of the large measurement range of EUROIMMUN RIA, further measurements with other sample dilutions are generally not necessary. Simple evaluation of test results. Each test can be optionally evaluated with controls which are supplied in the test kit. Test kit-specific reference ranges are given for all controls. EUROIMMUN radioimmunoassays show the following analytical characteristics: High analytical specificity. High detection sensitivity. High clinical sensitivity and specificity. Good reproducibility. 30

31 EUROIMMUN Products for the Determination of Autoantibodies EUROIMMUN PRODUCTS FOR THE DETERMINATION OF AUTOANTIBODIES 31

32 Autoantibodies against Cell Nuclei (ANA) EUROIMMUN Products for the Determination of Autoantibodies EUROPLUS ANA Mosaic 20 (HEp-2 cells, primate liver, SS-A+SS-B BIOCHIPs, rib. P-prot.+Jo-1 BIOCHIPs: antibodies against SS-A/SS-B. Formats FA 1510-####-20 G page 129 Indirect Immunofluorescence Test: EUROPLUS ANA Mosaic 20 Screening test for the detection of antibodies against cell nuclei (ANA). Indications: rheumatic diseases. Initial dilution 1 : 100; conjugate class anti-human IgG, FITC-labelled. Using HEp-2 cells many antibodies against cell nuclei can be analyzed, e.g. antibodies against DNA, histones, RNA, nrnp, Sm, SS-A, SS-B, nuclear dots, centromeres, nuclear membrane, nucleoli (PM-Scl, fibrillarin, RNA polymerase I, NOR), Scl-70, cyclin I and II, spindle fibers, midbody, centrioles. In addition, cytoplasmic autoantibodies are identified with HEp-2 cells: antibodies against ribosomes, Jo-1, mitochondria, Golgi apparatus, actin etc. The primate liver permits the verification of results between both substrates, makes the pre-differentiation of a large number of ANA possible, and helps to establish titer levels. Moreover, the primate liver often contains additional antigens, allowing the identification of further autoantibodies: antibodies against LMA, LSP, endomysium, bile ducts and endothelium cells, as well as canca und panca. The EUROPLUS system is a monospecific test that can be used to confirm the presence of autoantibodies against cell nuclei and cytoplasm with one and the same test kit. The following antigens are currently available as EUROPLUS BIOCHIPs: SS-A, SS-B, nrnp/sm, Sm, Scl-70, Jo-1, ribosomal P-proteins. HEp-2010: antibodies against spindle fibers. Indirect Immunfluorescence Test: New Cell Line from EURO- IMMUN, HEp Screening test for detection of antibodies against cell nuclei. Indications: rheumatic diseases. Initial dilution 1 : 100; conjugate class anti-human IgG, FITC-labelled. Compared to standard HEp-2 cells, HEp cells demonstrate 10-fold more mitotic cells. Antibodies against mitotic-specific structures (centromeres, spindle fibers, midbody, centrioles, NOR) can be more easily identified than with conventional preparations. At the same time, the cell line HEp offers the full antigen spectrum for cell nuclei antibody diagnostics. The BIOCHIP with HEp can be supplemented with additional substrates, for example, primate liver (ANA; FA 1512-####-1 G) as well as rat kidney and rat stomach ( FA 1802-####-3 G). Formats FA 1522-#### G page 130 Incubated EUROASSAY Anti-ENA ProfilePlus. EUROASSAY: Anti-ENA ProfilePlus Differentiation of anti-nuclear antibodies (ANA). Indications: rheumatic diseases. Serum dilution 1 : 100; conjugate class anti-human IgG, AP-labelled. 6 relevant anti-nuclear antibodies against extractable nuclear antigens (ENA) can be detected simultaneously and monospecifically: antibodies against nrnp/sm, Sm, SS-A, SS-B, Scl-70, Jo-1. Native antigens, purified by affinity chromatography. On request EUROASSAY can be produced with special antigen combinations, for example, with dsdna, histones, nucleosomes, PM-Scl, nrnp/sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, ribosomal P proteins, centromere protein B, M2, M4, M9, SLA/LP, LC-1, LKM-1. Formats DA 1590-####-1 G page 75 32

33 Autoantibodies against Cell Nuclei (ANA) EUROLINE: ANA Profile 3 Differentiation of antibodies against cell nuclei (ANA). Indications: Sharp syndrome (MCTD), systemic lupus erythematosus, Sjögren s syndrome, progressive systemic sclerosis, poly/dermatomyositis, PBC. Serum dilution 1 : 100; conjugate class anti-human IgG, AP-labelled. With the EUROLINE ANA-Profile 3, fifteen autoantibodies can be determined: antibodies against nrnp/sm, Sm, SS-A, Ro-52, SS-B, Scl-70, PM-Scl, Jo-1, centromere protein B, PCNA, dsdna, nucleosomes, histones, ribosomal P-proteins, AMA M2. Antibodies against SS-A are characteristic markers for SLE and Sjögren s syndrome. In contrast, antibodies against Ro-52 also occur in patients with other autoimmune diseases. Native antigens, purified by affinity chromatography (exception: centromere protein B, PM-Scl, Ro-52, PCNA). Further antigen combinations: page 76. Test strips can be automatically incubated and evaluated using the systems EUROBlotMaster und EUROLineScan (see page 28). nrnp/sm Sm SS-A Ro-52 SS-B Scl-70 PM-Scl Jo-1 CENP B PCNA dsdna nucleos. histones rib. P-prot. AMA M2 control Incubated EUROLINE ANA Profile 3. Formats DL G page 76 EUROIMMUN Products for the Determination of Autoantibodies EUROLINE: Myositis Profile Differentiation of myositis-associated antibodies against cell-nuclear and cytoplasmic antigens. Indications: poly/dermatomyositis. Serum dilution 1 : 100, conjugate class anti-human IgG, AP-labelled. With the EUROLINE Myositis Profile, seven autoantibodies can be determined: antibodies against Mi-2, Ku, PM-Scl, Jo-1, PL-7, PL-12 and Ro-52. Test strips can be automatically incubated and evaluated using the systems EUROBlotMaster und EUROLineScan (see page 28). Mi-2 Ku PM-Scl Jo-1 PL-7 PL-12 Ro-52 control Incubated EUROLINE Myositis Profile. Formats DL G page 76 EUROLINE-WB: HEp-2 Cell Antigens plus SS-A, Ro-52 and CENP B Differentiation of antibodies against cell-nuclear and cytoplasmic antigens. Indications: Sharp syndrome (MCTD), systemic lupus erythematosus, Sjögren s syndrome, progressive systemic sclerosis, poly/dermatomyositis, PBC. EUROLINE-WB is a combination of westernblot and line blot techniques. Proteins from a whole antigen extract of HEp-2 cells are electrophoretically separated according to molecular mass and transferred onto a nitrocellulose membrane. A membrane chip coated with highly purified native SS-A, recombinant Ro-52 and recombinant CENP B is then added to the westernblot strips. Antibodies against SS-A are characteristic markers for SLE and Sjögren s syndrome. In contrast, antibodies against Ro-52 also occur in patients with other autoimmune diseases. EUROLINE-WB contains both antigens next to each other at defined positions, in addition to the complete HEp-2 antigen spectrum of the Westernblot. The use of native SS-A increases the sensitivity, since 37% of antibodies against SS-A do not show any reaction with the denatured antigen from the Westernblot Serum dilution 1 : 50, conjugate class anti-human IgG, AP-labelled. Antigens: SDS extract from HEp-2 cells (whole antigen), highly purified native SS-A from calf thymus, recombinant Ro-52 and CENP B. rec. CENP B CENP B Ku RNP 70 RNP A Sm B/B Rib.-P native SS-A rec. Ro-52 SS-A Ro-52 Incubated EUROLINE-WB HEp-2 Cell Antigens plus SS-A, Ro-52 and CENP B. Formats DW G page 78 33

34 Autoantibodies against Cell Nuclei (ANA) EUROIMMUN Products for the Determination of Autoantibodies Incubated ELISA ANA Screen (antigen mixture of dsdna, histones, nrnp/sm, Sm, SS-A, SS-B, Scl- 70, Jo-1, ribosomal P-proteins, centromere). Microplate ELISA: ANA Screen, Anti-ENA PoolPlus Screening test for predifferentiation of antibodies against cell nuclei (ANA) and cytoplasm components. Indications: Sharp syndrome (MCTD), systemic lupus erythematosus, Sjögren s syndrome, progressive systemic sclerosis, polymyositis/dermatomyositis. Serum dilution 1 : 200, conjugate class anti-human IgG, POD-labelled. One microplate well incubated per patient. 1-point calibration, semiquantitative. Native antigens (exception: centromere, recombinant). The ANA Screen ELISA supplements the gold standard immunofluorescence. It is based on a mixture of 10 highly purified antigens, which provide higher sensitivity and specificity than the undefined cell extracts used by other manufacturers. Two ELISAs with different antigen combinations, adapted to particular indications or for follow-up of immunofluorescence patterns, are available. Formats EA G page 82 Incubated ELISA Anti-ENA ProfilePlus 2 (antigens: ribosomal P-proteins, nrnp/sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromere). Microplate ELISA: SLE Profile 1/2, Anti-ENA ProfilePlus 1/2 Differentiation of antibodies against cell nuclei (ANA) and cytoplasm components. Indications: Sharp syndrome (MCTD), systemic lupus erythematosus, Sjögren s syndrome, progressive systemic sclerosis, polymyositis/dermatomyositis. Serum dilution 1 : 200; conjugate class anti-human IgG, POD-labelled. 8 or 6 relevant antibodies can be detected simultaneously. 1-point calibration, semiquantitive. Calibrator pool and negative controls each on a separate microplate strip (SLE Profiles and Anti-ENA ProfilePlus 2) or on the same microplate strip as the patient serum. Native antigens (exception: Ro-52, centromere and PM-Scl, recombinant). In total 4 different ELISAs with different antigen combinations, adapted to particular indications or for follow-up of immunofluorescence patterns, are available. Formats EA G page 82 Incubated ELISA Anti-SS-A, Anti-SS-B. Formats EA ####-9601 G page 82 Microplate ELISA: ANA Single-Antigen ELISAs Differentiation of antibodies against cell nuclei (ANA) and cytoplasm components. Indications: rheumatic diseases. Serum dilution 1 : 200; conjugate class anti-human IgG, POD-labelled. Antibodies against cell nuclei components can be determined quantitatively in RU/ml. 3-point calibration, quantitative. Identical incubation conditions and times: all single-antigen tests can be combined with each other on one microplate. Native antigens (exceptions: centromere and PM-Scl, recombinant). Single-antigen ELISAs available for detection of antibodies against cell nuclei and cytoplasm antigens: ssdna, nucleosomes, dsdna, histones, ribosomal P proteins, PM-Scl, nrnp/sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromere. ANA VarioProfile: ELISA test kits (total 12 strips, maximum 4 different microplate strips) can be individually put together from 14 different antigen-coated microplate strips: ssdna, nucleosomes, dsdna, histones, ribosomal P-proteins, PM- Scl, nrnp/sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromere, AMA M2. 34

35 Autoantibodies against Double-Stranded DNA (dsdna) Indirect Immunofluorescence Test: Crithidia luciliae Detection of antibodies against dsdna. Indication: lupus erythematosus disseminatus. Initial dilution: 1:10, conjugate class anti-human IgG, FITC-labelled. Animal pathogenic haemoflagellates of Crithidia luciliae are used for the detection of autoantibodies against double-stranded, native DNA (dsdna, ndna) with indirect immunofluorescence. These protozoa possess a giant mitochondrion containing dsdna (kinetoplast) that, in general, does not show any of the other antigens present in the cell nuclei. Antibodies reacting with the kinetoplast are therefore only directed against dsdna. For the detection of antibodies against dsdna, the sensitivity is much higher when using Crithidia luciliae than with HEp-2 cells or tissue sections. This is due to the different antigen density in the substrate and, when using Crithidia luciliae, the sera is diluted 10 times higher than in the ANA standard test. ELISA or RIA systems are generally more sensitive than the Crithidia luciliae IFT, but the immunofluorescence has a higher specificity for SLE. A titer of 1:10 or more combined with SLE symptoms is indicative of the disease. Crithidia luciliae: antibodies against dsdna. EUROIMMUN Products for the Determination of Autoantibodies Formats FA 1572-#### page 131 Microplate ELISA: Anti-dsDNA-NcX Monospecific detection of antibodies against dsdna. Indication: lupus erythematosus disseminatus. Serum dilution 1: 200, conjugate class anti-human IgG, POD-labelled. Antibodies against dsdna can be determined quantitatively in IU/ml. 3-point calibration, quantitative. Antigen: double-stranded DNA, complexed with nucleosomes (NcX). Due to good sensitivity and specificity, the Anti-dsDNA-NcX ELISA stands out by high diagnostic efficiency. High concentrations of autoantibodies against dsdna in the ELISA are considered to be a reliable marker for the diagnosis or prognosis of SLE. Individual changes in the dsdna antibody concentration correlate with the activity of the disease and can be used for monitoring the development of the disease in SLE patients. In cases of immunosuppressive therapy or clinical remission dsdna antibodies cannot be detected with the ELISA anymore. Incubated ELISA Anti-dsDNA-NcX. Formats EA G page 81 Anti-dsDNA RIA by Farr Monospecific detection of antibodies against dsdna. ndication: lupus erythematosus disseminatus. Use of undiluted samples. Antigen: 125I-labelled dsdna from plasmid DNA. The Farr radioimmunoassay has always been of great importance. On the whole, it has the same specificity as the immunofluorescence test and the same sensitivity as the ELISA. Apparently, its well-known high diagnostic efficiency is based on the fact that only the fraction of the anti-dsdna antibodies which is able to form bigger precipitating immune complexes with circulating DNA in liquid phase contributes to the measuring signal. The principle of the Farr test reflects, so to speak, the significant step in the pathomechanism of SLE: the formation of appropriate immune complexes, deposits of which build up in the joints, kidneys, liver and other organs. RIA Anti-dsDNA. Formats RA page 84 35

36 Autoantibodies against Cyclic Citrullinated Peptide (CCP) EUROIMMUN Products for the Determination of Autoantibodies Microplate ELISA: Anti-CCP Screening test for the specific determination of autoantibodies against cyclic citrullinated peptide (CCP). Indication: rheumatoid arthritis (RA). Serum dilution 1 : 100; conjugate class anti-human IgG, POD-labelled. Antibodies against CCP can be determined quantitatively in RU/ml. Optional reference control for the determination of ratio values. Antigen: synthetic cyclic citrullinated peptides (CCP, second generation). Incubated ELISA Anti-CCP. Formats EA G page 81 Antibodies against cyclic citrullinated peptides (CCP): An ELISA for specific diagnosis of rheumatoid arthritis H N O Peptidylargininedeiminase (PAD) H N O peroxidase-labelled anti-human antibody colourless chromogen stain POD POD NH Ca 2+ NH human antibody against CCP H 2 N + NH 2 L-arginine O NH 2 L-citrulline synthetic CCP The amino acid citrulline Principle of the anti-ccp ELISA Anti-CCP ELISA Rheumatoid arthritis (RA) is one of the most common autoimmune diseases, affecting around 1% of the world population. It is characterised by inflammation of the synovial membrane, which spreads symmetrically from the small to the large joints. Initial symptoms include painful swelling of finger joints with morning stiffness in the joints. Early diagnosis and immediate commencement of suitable therapy is necessary to keep the disease under control. The most commonly performed serological test in suspected RA cases was until now the determination of rheumatoid factors (RF). These are antibodies (predominantly of class IgM) which react with gamma globulins and occur in 60-80% of RA patients. RF are a sensitive but not very specific marker for RA, since they also occur in healthy individuals and in patients with various infections or other autoimmune diseases (systemic lupus erythematosus, Sjögren s syndrome, scleroderma and others) % of RA patients also exhibit autoantibodies against epidermal filaggrin 1 (RA keratin, anti-perinuclear factor) in their serum. Filaggrin is a protein of the epidermis, which links keratin filaments to one another. Autoantibodies against filaggrin are detected by indirect immunofluorescence: the antigen substrate rat oesophagus shows staining of the stratum corneum (RA keratin) on the luminal side; anti-perinuclear factors (APF) are apparent in the cytoplasmic inclusion bodies of human epithelial cells of the oral mucosa. In recent years it has been shown that the rare amino acid citrulline, which is present in filaggrin, is a substantial component of the antigenic epitope. Enzyme immunoassays which use synthetic citrullinated peptide as the target antigen offer a useful alternative to indirect immunofluorescence 2. A direct comparison study demonstrated that the sensitivity can be increased from 49% to 68% by using cyclic citrullinated peptide instead of linear citrullinated peptide as an ELISA substrate 3. Antibodies against cyclic citrullinated peptides (CCP) are a new and highly specific marker for RA. Antibodies against CCP are predominantly of class IgG and have a specificity of 98% for RA. They are observed very early in the disease course and have a high predictive value: patients with anti-ccp antibodies develop significantly more radiologically detectable joint damage than anti-ccpnegative patients 4. Antibodies against CCP possess a much higher specificity than RF (anti-ccp: 97%, RF: 62%) with the same sensitivity (anti-ccp: 79%, RF: 78%) 5. They can be detected in early stages of the disease in 79% of patients. EUROIMMUN offers an innovative microplate ELISA for quantitative determination of autoantibodies against CCP. Diluted patient sera are incubated in wells coated with synthetic cyclic citrullinated peptides (second generation). Specific antibodies in the serum bind to the immobilised antigen and cause a photometric colour reaction by means of an enzyme-coupled secondary antibody. Five calibration sera ensure reliable measurement of antibody concentrations. The EURO- IMMUN Anti-CCP ELISA is a highly specific and sensitive serological test system for the diagnosis of RA. Panel n Anti-CCP positive Sensitivity for RA (78.5%) Asymptomatic blood donors Psoriatic arthritis Other arthritides System. lupus erythematosus Sjögren's syndrome (0.5%) (8.6%) (2.8%) (1.9%) Scleroderma 98 3 (3.1%) Autoimmune thyroiditis Wegener's granulomatosis Anti-parvovirus B19-positive (2.5%) 25 1 (4.0%) (2.4%) Viral hepatitides 54 0 Anti-HIV positive 5 0 Specificity for RA (98.2%) 1) Nogueira et al., Ann. Rheum. Dis. 60: 882 (2001) 2) Schellekens et al., J. Clin. Invest. 101: (1998) 3) Schellekens et al., Arthritis Rheum. 43: (2000) 4) Kroot et al., Arthritis Rheum. 43: (2000) 5) Vasishta, Am. Clin. Lab. 21: (2002) 36

37 Autoantibodies against Mitochondria (AMA) Indirect Immunofluorescence Test: EUROPLUS Rat Kidney and M2 BIOCHIPs Screening test for the detection of antibodies against mitochondria (AMA) including simultaneous confirmation of the subtype AMA M2. Indication: primary biliary cirrhosis (PBC). Initial dilution 1 : 100; polyvalent conjugate anti-human IgM, FITC-labelled. Rat kidney is the standard substrate for detecting anti-mitochondrial antibodies. Nine AMA types (M1 to M9) can be differentiated. The BIOCHIP coated with M2 permits monospecific confirmation of antibodies against the mitochondrial antigen M2 (pyruvate dehydrogenase complex) in one single test procedure, thus a PBC can be diagnosed serologically with confidence. This BIOCHIP Mosaic can be supplemented as required using additional substrates, e.g. HEp-2 cells (ANA, nuclear dots), rat liver (liver-kidney microsomes, LKM) or rat stomach (ASMA). Rat kidney and M2 BIOCHIP: antibodies against mitochondria (AMA). EUROIMMUN Products for the Determination of Autoantibodies Formats FA 1620-####-3 page 131 EUROASSAY: AMA Profile M2, M4, M9 Differentiation of mitochondrial antibodies (AMA). Indication: primary biliary cirrhosis (PBC). Serum dilution 1 : 100; conjugate class anti-human IgGM, AP-labelled. 3 relevant mitochondrial antibodies can be detected simultaneously and monospecifically: antibodies against M2, M4, M9. Native antigens: pyruvate dehydrogenase complex (M2), sulfite oxidase (M4), glycogen phosphorylase (M9). Anti- Associated diseases M2 Primary biliary cirrhosis (high titers), other chronic liver diseases M4 Primary biliary cirrhosis M9 Early phase of primary biliary cirrhosis Incubated EUROASSAY AMA Profile M2, M4, M9. Formats DA 1620-####-1 O page 75 Microplate ELISA: Anti-M2-3E Differentiation of mitochondrial antibodies (AMA). Indication: primary biliary cirrhosis (PBC). Serum dilution 1 : 200; conjugate class anti-human IgG, POD-labelled. Antibodies against M2 can be determined quantitatively in RU/ml. Antigen: native pyruvate dehydrogenase complex plus recombinant M2 fusion protein (BPO) containing the immunogenic domains of the E2 subunits of PDH, BCOADH and OGDH. Incubated ELISA anti-m2-3e. Formats EA G page 83 37

38 Autoantibodies against Liver Antigens EUROIMMUN Products for the Determination of Autoantibodies HEp-2 cells: anti-nuclear dots. Primate liver: anti- LSP. Rat kidney: AMA. Rat liver: ANA. Rat stomach: ASMA. VSM47: Anti-actin. Indirect Immunofluorescence Test: Liver Mosaic 8 Screening and differentiation test for the detection of liver-specific antibodies, antibodies against mitochondria (AMA), antibodies against cell nuclei (ANA), antibodies against smooth muscles (ASMA), F-actin and other autoantibodies. Indications: autoimmune hepatitis, primary biliary cirrhosis, rheumatic diseases. Initial dilution 1 : 100; polyvalent conjugate anti-human IgM, FITC-labelled. The BIOCHIP Mosaic consists of 6 substrates: human epithelial cells (HEp-2), primate liver, rat kidney, rat liver, rat stomach, VSM47. Thus, a broad spectrum of antigens is present, allowing not only targeted serological diagnoses, but also frequently yielding additional results with clinical relevance. Antibodies against cell nuclei (ANA) can be particularly well demonstrated using HEp-2 cells and primate liver, and are identified according to their fluorescence patterns. However, they also stain the cell nuclei of the other tissues more or less intensely. Clinical significance: rheumatic diseases, primary biliary cirrhosis (antibodies against nuclear dots). With primate liver, several liver-specific autoantibodies can be investigated e.g. antibodies against liver cell membrane (anti-lma) and liver-specific protein (anti- LSP). Clinical significance: autoimmune hepatitis. Antibodies against mitochondria (AMA) show a granular cytoplasmic fluorescence on all 6 substrates. With the standard substrate rat kidney, the proximal and distal tubule cells fluoresce equally. Clinical significance: primary biliary cirrhosis. Autoantibodies against liver-kidney microsomes (anti-lkm) react with rat liver and rat kidney (see below). The other substrates are essentially negative. In the case of autoantibodies against smooth muscles (ASMA), the tunica muscularis, the lamina muscularis mucosa as well as the interglandular contractile fibrils in the tunica mucosa fluoresce on the rat stomach. ASMA directed against the target antigen F-actin furthermore react with the cytoskeleton of HEp- 2 cells and the bile canaliculi of primate liver. The substrate VSM47 reacts very specifically, showing a filamentous, needle-like fluorescence. Clinical significance: autoimmune (lupoid) chronic active hepatitis. The BIOCHIP Mosaic can be supplemented as required with additional substrates, e.g. Crithidia luciliae (antibodies against dsdna), musculus iliopsoas (antibodies against skeletal muscles), heart (antibodies against striated muscles, antibodies against intercalated disks, AMA M7), different EUROPLUS substrates (AMA M2, Sp100, SLA/LP, LC-1). Formats FA 1300-####-8 page 125 Rat liver and rat kidney: antibodies against liverkidney microsomes (anti-lkm). Formats FA 1300-####-1 page 125 Indirect Immunofluorescence Test: BIOCHIP Mosaic Rat Liver/Rat Kidney (Liver Mosaic 1) Specific detection of antibodies against liver-kidney microsomes (anti-lkm). Indications: autoimmune hepatitis, often associated with extrahepatic syndromes such as arthralgias, glomerulonephritis, vitiligo and chronic inflammatory bowel diseases. Initial dilution 1 : 100; polyvalent conjugate anti-human IgM, FITC-labelled. Autoantibodies against liver-kidney microsomes react with rat liver and generate a smooth staining in the cytoplasm of the hepatocytes. In rat kidney, particularly in the cortex area, a fine granular fluorescence of the proximal tubules recognizable by the luminal brush border is visible. The distal tubules are negative. The fluorescence intensity of the liver cells is normally stronger than that of the proximal renal tubules. The differentiation between autoimmune hepatitis and virus-induced hepatitis can additionally be accomplished by investigating the appropriate viral parameters. 38

39 Autoantibodies against Liver Antigens EUROLINE: Profile Autoimmune Liver Diseases Differentiation of antibodies in autoimmune liver diseases. Indications: autoimmune hepatitis, primary biliary cirrhosis, overlap syndromes. Serum dilution 1 : 100, conjugate class anti-human IgG, AP-labelled. With the EUROLINE Profile Autoimmune Liver Diseases, nine autoantibodies can be determined: antibodies against AMA M2, M2-3E (BPO), Sp100, PML, gp210, LKM-1, LC-1, SLA/LP and Ro-52. Test strips can be automatically incubated and evaluated using the systems EUROBlotMaster und EUROLineScan (see page 28). Further antigen combinations on page 77. AMA M2 3E (BPO) Sp100 PML gp210 LKM-1 LC-1 SLA/LP Ro-52 EUROIMMUN Products for the Determination of Autoantibodies Anti- Associated Diseases M2, Sp100, PML, gp210 Primary biliary cirrhosis LKM-1, SLA/LP, LC-1 Autoimmune hepatitis Ro-52 Autoimmune hepatitis, rheumatic diseases control Incubated EUROLINE Profile Autoimmune Liver Diseases. Formats DL G page 76 EUROASSAY: Liver Profile (Anti-M2, -LKM-1, LC-1, -SLA/LP) Determination of mitochondrial antibodies AMA M2, antibodies against liverkidney microsomes type 1 (LKM-1), antibodies against liver cytosolic antigen type 1 (LC-1), as well as of antibodies against soluble liver antigen/liver-pancreas antigen (SLA/LP). Indication: autoimmune liver diseases. Serum dilution 1 : 100, conjugate class anti-human IgG, AP-labelled. Antibodies against M2, LKM-1, LC-1 and SLA/LP can be detected simultaneously and monospecifically. Antigens: pyruvate dehydrogenase complex (M2, native), cytochrome P450 IID6 (LKM-1, recombinant), formiminotransferase-cyclodeaminase (LC-1, recombinant) and soluble liver antigen/liver-pancreas antigen (SLA/LP, recombinant). Incubated EUROASSAY M2, LKM-1, LC-1, SLA/LP. Formats DA G page 75 Microplate ELISA: Anti-SLA/LP, Anti-LC-1, Anti-LKM-1 Monospecific determination of antibodies against soluble liver antigen/liverpancreas antigen (SLA/LP), cytosolic liver antigen type 1 (LC-1) and liver-kidney microsomes type 1 (LKM-1). Indication: autoimmune hepatitis. Serum dilution 1 : 100, conjugate class anti-human IgG, POD-labelled. 3-point calibration, quantitative (exception: Anti-LC-1, semi-quantitative). Identical incubation conditions and times: all tests can be combined without difficulty on one and the same microplate. Recombinant antigens: soluble liver antigen/liver-pancreas antigen (SLA/LP), formiminotransferase-cyclodeaminase (LC-1) and cytochrome P450 IID6 (LKM-1). The corresponding human cdna was expressed in E. coli (SLA/LP) or insect cells (LC-1, LKM-1). Incubated ELISA Anti-SLA/LP, Anti-LC-1, Anti-LKM-1. (anti-sla/lp) Formats EA G page 81 39

40 Autoantibodies against Thyroid Gland Antigens / Antigen Detections EUROIMMUN Products for the Determination of Autoantibodies Thyroid gland, unfixed and thyroglobulin BIOCHIP: antibodies against thyroid microsomes and thyroglobulin. Formats FA 1010-####-3 page 120 Indirect Immunofluorescence Test: EUROPLUS Thyroid Gland (unfixed) and Thyroglobulin Detection of antibodies against thyroid gland antigens. Indications: autoimmune thyroid diseases (Basedow s disease, Hashimoto autoimmune thyroiditis). Initial dilution 1 : 10; conjugate class anti-human IgG, FITC-labelled. Using unfixed thyroid tissue, two important thyroid-specific antibodies can be found: Autoantibodies against thyroid microsomes (MAb) give a granular staining in the cytoplasm of the follicle epithelium (target antigen: thyroid peroxidase, TPO). Autoantibodies against thyroglobulin (TAb) react with the colloid of all follicles of the thyroid tissue and cause a reticular fluorescence pattern. With the thyroglobulin-coated BIOCHIP, autoantibodies against thyroglobulin (TG) can be confirmed monospecifically in one and the same test procedure. This BIOCHIP Mosaic can be supplemented as required with further substrates, e.g. rat kidney, to achieve a differentiation of antibodies against thyroid microsomes from mitochondrial antibodies (AMA). For a serological diagnosis of autoimmune polyendocrinopathies, BIOC RIA for thyroid diagnostics. (anti-tpo) Formats RA 1012-####-# page 84 Radioimmunoassays (RIA/IRMA): Thyroid Specific Autoantibodies, Antigens and Hormones Monospecific detection of autoantibodies against thyroglobulin (TG), thyroid peroxidase (TPO) and thyrotropin receptor (TSH-R). Specific detection of the thyroid antigen thyrotropin and the hormones free triiodothyronine (FT3), free thyroxine (FT4), thyrotropin (TSH), calcitonin. Indications: autoimmune hyperthyrose s (Graves' disease, Hashimoto's thyroiditis), medullary thyroid carcinoma, thyroidal C-cell hyperplasia, therapy controls in hyper- and hypothyrosis. Serum dilutions: 1:50 for anti-tg and anti-tpo (magnetic), 1:20 for anti-tg and anti-tpo (precipitation), undiluted for all remaining test kits. 5-point to 8-point calibration (quantitative). Analyte Analyte Anti-TPO RA 1012-####-# FT3 RD Anti-TG RA # FT4 RD TRAb RA TSH RD Thyrotropin RD Calcitonin RD Incubated ELISA Anti-Thyroid antigens. (Anti-TPO) Formats EA G page 81 Microplate ELISA: Anti-Thyroglobulin, Anti-Thyroid Peroxidase, Anti-TSH receptor Monospecific determination of antibodies against thyroglobulin (TG), thyroid peroxidase (TPO), and thyrotropin receptor (TSH-R). Indications: autoimmune thyroid diseases (Grave s disease, Hashimoto autoimmune thyroiditis). Serum dilution 1 : 200 (exception: anti-tsh-r undiluted); conjugate class antihuman IgG, POD-labelled (anti-tsh-r: avidin-labelled). 3-point calibration (exception: anti-tsh-r, 5-point calibration or semi-quantitative). The quantification is carried out according to international reference preparations (anti-tg: NIBSC 65/93; anti-tpo: NIBSC 66/387; anti-tsh-r: NIBSC 90/672). Thyroglobulin/TSH-R: native antigen; thyroid peroxidase: recombinant antigen. Antigen Thyroid peroxidase Thyroglobulin TSH receptor EA G EA G EA G 40

41 Autoantibodies against Neuronal Antigens Indirect Immunofluorescence Test: BIOCHIP Mosaic Cerebellum/ Peripheral Nerves/Intestinal Tissue Screening test for the detection of antibodies against neuronal antigens. Indications: neurological diseases. Initial dilution 1 : 10; conjugate class anti-human IgM, FITC-labelled. Primate cerebellum and primate nerves are the standard substrates for the determination of various neuronal antibodies. The parallel use of primate intestine permits the reliable differentiation from other autoantibodies (e.g. ANA) and makes it possible to distinguish between anti-ri and anti-hu. Antibodies against grey matter react intensively with the stratum granulosum and in a weaker form with the stratum moleculare of the cerebellum. Target antigen: glutamic acid decarboxylase (GAD). Clinical significance: stiff man syndrome, diabetes mellitus type I. Antibodies against Yo stain exclusively the cytoplasm of the Purkinje cells in the cerebellum. Clinical significance: paraneoplastic cerebellum syndrome, indication of a malignoma. In the case of antibodies against Hu and Ri all neurone nuclei in the grey matter show a granular fluorescence. Hu antibodies react in the intestine with cell nuclei of the plexus myentericus, whereas Ri antibodies do not. Clinical significance: paraneoplastic cerebellum syndrome, indication of a malignoma. Antibodies against neurofilaments appear as a fibrillar structure particularly in the stratum granulosum. Clinical significance: dysglobulinemias with progressive axonal polyneuropathy. The white matter of the cerebellum is stained by antibodies against myelin, which appear as hyaline cylinders on tissue sections of peripheral nerves. Clinical significance: multiple sclerosis (controversial). However, antibodies against myelin-associated glycoprotein (M) cause a rather streaked fluorescence pattern. They can be found in patients with Guillain- Barré syndrome. Antibodies against non-medullated nerves react in various organs with segments of autonomous nerves. In the intestine, antigens against plexus myentericus and plexus submucosus are targeted. They can be detected in chronic-inflammatory bowel diseases. The BIOCHIP Mosaic can be supplemented as required with further substrates, e.g. cerebrum (antibodies against astrocytes), primate liver (ANA), Crithidia luciliae (anti-dsdna), primate stomach (parietal cell antibodies), Borrelia (neuroborreliosis-associated). Cerebellum: antibodies against GAD and Yo (top), against Hu and Ri (middle). Peripheral nerves: antibodies against myelin and M (bottom). EUROIMMUN Products for the Determination of Autoantibodies Formats FA 1111-####-1 page 121 EUROLINE: Neuronal Antigens Profile Differentiation of antibodies against neuronal antigens. Indication: paraneoplastic neurologic syndromes (PNS). Serum dilution 1 : 100; conjugate class anti-human IgG, AP-labelled. With the EUROLINE Profile Neuronal Antigens, six autoantibodies can be determined: antibodies against amphiphysin, CV2/CRMP5, PNMA2 (Ma2/Ta), Ri, Yo and Hu. Test strips can be automatically incubated and evaluated using the systems EUROBlotMaster und EUROLineScan (see page 28). Additionally, EUROIMMUN offers a Westernblot for the detection of antibodies against neuronal antigens: DW G. amphiphysin CV2/CRMP5 PNMA2 (Ma2/Ta) Ri Yo Hu control Incubated EUROLINE Neuronal Antigens Profile. Formats DL G page 76 41

42 Autoantibodies against Islet Cell Antigens EUROIMMUN Products for the Determination of Autoantibodies Primate pancreas: antibodies against islet cells. Formats FA 1020-#### page 120 Indirect Immunofluorescence Test: Primate Pancreas Detection of antibodies against islet cells. Indications: Differentiation between a late manifestation of diabetes type 1 (latent autoimmune diabetes in adulthood, LADA) and diabetes type 2. Initial dilution 1 : 10; conjugate class anti-human IgG, FITC-labelled. For a reliable determination of antibodies against islet cells an extended incubation time of 18 hours for the patient serum must be observed. The incubation time may be reduced to 2 hours but this will lead to a decrease in the sensitivity of the antibody detection test. The comparison with a simultaneously tested control serum (order no: CA ) allows the determination of the antibody concentration in JDF units. With indirect immunofluorescence autoantibodies against pancreas islets (ICA) can be detected in 80% of patients with new-onset diabetes type 1. Two target antigens of ICA have been identified so far: the enzymes glutamic acid decarboxylase (GAD) and tyrosine phosphatase (IA2). This BIOCHIP may be supplemented with further substrates, e. g. primate cerebellum for the detection of antibodies against GAD. Incubated ELISA anti-gad. (Anti-GAD) Formats EA G page 81 Microplate ELISA: Anti-GAD, Anti-IA2, Anti-GAD/IA2 Pool Monospecific detection of antibodies against glutamic acid decarboxylase (GAD), tyrosine phosphatase (IA2) or bispecific detection of both antibodies in a single reagent well. Indications: early diagnosis of diabetes mellitus type 1, risk prediction in first grade relatives, prognosis of the clinical progression of diabetes type 1 for prediction of insulin dependence, differential diagnosis in gestational diabetes, differentiation between a late manifestation of diabetes type 1 (latent autoimmune diabetes in adulthood, LADA) and diabetes type 2. Use of undiluted samples. Similar incubation conditions and times. Manual or automated test performance. Multipoint calibration. The quantitation is based on an international reference preparation (NIBSC 97/550). GAD and IA2: human, recombinant antigens. Antigen Order no. Glutamic acid decarboxylase (GAD) EA G Tyrosinr phosphatase (IA2) EA G GAD/IA2 Pool EA G RIA Anti-IA2. (Anti-IA2) Formats RA 1023-#### page 84 RIA: Anti-GAD, Anti-IA2, Anti-Insulin Monospecific detection of antibodies against glutamic acid decarboxylase (GAD), tyrosine phosphatase (IA2) and insulin. Indications: Early diagnosis of diabetes mellitus type 1, risk prediction in first grade relatives, prognosis of the clinical progression of diabetes type 1 for prediction of insulin dependence, differential diagnosis in gestational diabetes, differentiation between a late manifestation of diabetes type 1 (latent autoimmune diabetes in adulthood, LADA) and diabetes type 2. Use of undiluted samples. Similar incubation conditions and times. Manual or automated test performance. Test kit formats for 50 or 100 determinations. GAD and IA2: human, recombinant, 125 I-labelled antigens, insulin: human, synthetic, 125 I-labelled antigen. Antigen Order no. Glutamat-Decarboxylase (GAD) RA 1022-#### Tyrosin-Phosphatase (IA2) RA 1023-#### Insulin RA 1024-#### 42

43 Autoantibodies against Parietal Cells (PCA) Indirect Immunfluorescence Test: Primate Stomach with Urea Pretreatment Screening test for detection of antibodies against parietal cells. Indications: forms of chronic atrophic gastritis, pernicious anemia, funicular myelosis, various autoimmune endocrinopathies such as Basedow s and Addison s diseases. Initial dilution 1 : 10; polyvalent conjugate anti-human IgM, FITC-labelled. Primate stomach is the standard substrate for detection of parietal cell antibodies. For titration, stomach tissue from rat or mouse is sufficient. With positive results the parietal cells show a course granular to clumpy fluorescence, and the surrounding areas are usually dark. Parietal cell antibodies (PCA) are often mixed up with antibodies against mitochondria (AMA) in microscopic analysis. The latter give an even fine granular fluorescence of the parietal cell cytoplasm, with the surrounding region showing a (weaker) reaction. For reliable differentiation of both types of antibody, a 30-minute pretreatment of the tissue sections with urea-glycine buffer (order no. ZF , see page 96) is recommended. The cytomplasmic fluorescence of parietal cells resulting from PCA occurs with the same intensity with or without urea pretreatment. The typical pattern of mitochondrial antibodies is almost completely supressed by urea pretreatment, greatly facilitating PCA diagnostics. In some AMA-positive samples it is possible to detect PCA that are obscured by the AMA pattern in conventional tissue sections. The urea-pretreated tissue shows a significantly darker background, enabling specific fluorescence to be more easily and reliable identified. This BIOCHIP can be supplemented with additional substrates, for example, thyroid (thyroid peroxidase, thyroglobulin), pancreas (pancreas islets), adrenal gland (adrenal cortex), ovary (ovary antigens), testis (Leydig cells), and intrinsic factor. Primate stomach: antibodies against parietal cells. With urea-pretreatment (top) and without ureapretreatment (bottom). EUROIMMUN Products for the Determination of Autoantibodies Primate stomach: antibodies against mitochondria. With urea-pretreatment (top) and without urea-pretreatment (bottom). Formats FA 1360-#### G page 126 Microplate ELISA: Anti-Parietal Cells Monospecific detection of antibodies against parietal cells (PCA). Indications: forms of chronic atrophic gastritis, pernicious anemia, funicular myelosis, various autoimmune endocrinopathies such as Basedow s and Addison s diseases Serum dilution 1 : 200; conjugate class anti-human IgG, POD-labelled. 3-point calibration, quantitative. Native antigen: H + /K + -ATPase, purified by affinity chromatography. Incubated ELISA Anti-Parietal Cells. Formats EA G page 81 43

44 Autoantibodies against Granulocyte Cytoplasm (canca/panca) EUROIMMUN Products for the Determination of Autoantibodies EUROPLUS Granulocyte Mosaic 23 (granuloc. (EOH), granuloc. (HCHO), PR3, MPO, HEp-2, primate liver): pattern panca, formalin-resistant. Formats FA 1201-####-23 page 124 Indirect Immunofluorescence Test: EUROPLUS Granulocyte Mosaic 23 Screening test for the detection of antibodies against granulocyte cytoplasm (ANCA). Indications: Wegener s granulomatosis, various forms of glomerulonephritis, primary sclerosing cholangitis, ulcerative colitis, Crohn s disease. Initial dilution: serum 1 : 10; conjugate class anti-human IgG, FITC-labelled. Using ethanol-fixed granulocytes, antibodies against granulocyte cytoplasm can be detected. In this case, two fluorescence patterns have to be differentiated: a granular fluorescence which is distributed evenly over the entire cytoplasm, leaving the cell nuclei free (cytoplasmic type, canca) or a smooth fluorescence wrapped ribbon-like around the cell nuclei (perinuclear type, panca). Antibodies against all relevant granulocyte antigens as well as against further, as yet unknown antigens are detected simultaneously: Pattern Target antigen Associated diseases canca Proteinase 3 Wegener s granulomatosis panca Myeloperoxidase Microscopic arteritis, Churg-Strauss syndrome, polyarteritis nodosa panca Elastase Ulcerative colitis, Crohn s disease, primary sclerosing cholangitis, systemic lupus erythematosus panca Cathepsin G Ulcerative colitis, primary sclerosing cholangitis, Crohn s disease panca Lysozyme Ulcerative colitis, primary sclerosing cholangitis, Crohn s disease panca Lactoferrin Ulcerative colitis, primary sclerosing cholangitis, Crohn s disease, systemic lupus erythematosus, rheumatoid arthritis canca BPI Primary sclerosing cholangitis, ulcerative colitis, or panca Crohn s disease panca unknown Ulcerative colitis, Crohn s disease The primate liver enables one to differentiate between panca and anti-nuclear antibodies (ANA) which can easily be confused when using ethanol-fixed granulocytes: In the case of a positive ANA result all nuclei of the hepatocytes fluoresce, whereas in the case of panca (as well as canca) only the granulocytes in the sinusoids of primate liver fluoresce. The EUROPLUS substrates PR3 and MPO are monospecific tests for the confirmation of results achieved with conventional granulocyte screening tests. They help to facilitate the evaluation of problematic fluorescence patterns (e.g. unspecific fluorescence caused by other cytoplasm antibodies). Incubated ELISA ANCA Profile (antigens: proteinase 3, lactoferrin, myeloperoxidase, elastase, cathepsin G, BPI. Formats EA G page 81 Microplate ELISA: ANCA Profile Differentiation of antibodies against granulocyte cytoplasm (ANCA). Indications: Wegener s granulomatosis, various forms of glomerulonephritis, primary sclerosing cholangitis, ulcerative colitis, Crohn s disease. Serum dilution 1 : 100; conjugate class anti-human IgG, POD-labelled. 6 relevant anti-granulocyte antibodies can be detected simultaneously and monospecifically: autoantibodies against proteinase 3, lactoferrin, myeloperoxidase, elastase, cathepsin G, BPI. 1-point calibration, semi-quantitative. Calibrator pool and serum sample on the same microplate strip. Native antigens, purified by affinity chromatography. Available individual ELISA (3-point calibration, quantitative): Antigen Proteinase 3 (classic ELISA) Proteinase 3 (Capture ELISA) Proteinase 3 (PR3-hn-hr: native/recombinant) Myeloperoxidase EA G EA G EA G EA G 44

45 Cost-effective Strategy for the Detection of Autoantibodies against Granulocyte Cytoplasm (ANCA) A Granulocytes (EOH-fixed) B Granulocytes (HCHO-fixed) Screening test indirect immunofluorescence: BIOCHIP quartet granulocytes (EOH), granulocytes (HCHO), human epithelial cells (HEp-2), and primate liver D Primate liver C HEp-2 cells Perinuclear fluorescence of granulocytes (A, D) Fluorescence of all cell nuclei (A, C, D) Fluorescence of all cell nuclei (A, C, D), granuloc. accent. (D) Cytoplasmic fluorescence of granulocytes (A, B, D) EUROIMMUN Products for the Determination of Autoantibodies panca only ANA ANA and panca canca MPA % CSS % SLE 9-25 % RA 3-25 % UC 67 % CD 7 % PSC 87 % WG % MPA % CSS % PAN < 9 % At B cytoplasmic fluorescence At B no cytoplasmic fluorescence Cytoplasmic fluorescence of granulocytes (B) Nuclei of granuloc. brighter than nuclei of hepatocytes (D), B neg. ANCA reaction at A, ANA reaction at C & D panca, formalin-resistant panca, formalin-sensitive panca, formalin-res. & ANA panca, formalin-sens. & ANA panca, formalin-sens.? & ANA MPA % ELISA: anti-mpo AAb against MPO MPA 53 % ELISA: ANCA Profile AAb against PR3, MPO, elastase, cathepsin G, BPI, lactoferrin WG MPA MPA RA, vasculitides SLE 5 % (BPI) 53 % (MPO) 3 % (LF) 45 % (LF) 6 % (EL) Qualified ANA diagnostics: screening test using HEp-2 cells/primate liver (C, D), differentiation using ELISA, EUROASSAY, EUROLINE, Westernblot AAb against dsdna, ssdna, nucleosomes, histones, nuclear membrane, nrnp/sm, Sm, SS-A, Ro-52, SS-B, Ku, cyclin I (PCNA), mitosin (CENP-F, cyclin II), nuclear dots, centromeres (CENP B), spindle fibres, midbody, centrioles, Scl-70, PM-Scl, fibrillarin, RNA polymerase I, NOR, ribosomal P-proteins, Jo-1, PL-7, PL-12, Mi-2, mitochondria (AMA), lysosomes, Golgi apparatus, vimentin, tropomyosin, actin. ELISA: anti-pr3 / anti-pr3 capture / ANCA Profile (BPI) AAb against PR3 (ELISA) WG 73 % AAb against PR3 (capture ELISA) WG 88 % AAb against BPI WG 5 % See EUROIMMUN poster: " Strategy for Determination of Autoantibodies against Cell Nuclei (ANA) and Cytoplasm Components" The highest diagnostic sensitivity in the determination of autoantibodies against neutrophil granulocytes (ANCA) is achieved by using indirect immunofluorescence and enzyme immunoassays with defined target antigens (particularly PR3 and MPO) simultaneously at the start. However, under the pressure of cost optimisation, an immunofluorescence test may be performed on its own and then followed up by specific ELISA tests only if the result is positive. Ethanol-fixed human granulocytes are the standard substrate for indirect immunofluorescence. With this substrate two relevant fluorescence patterns can be differentiated: the cytoplasmic type (canca) associated with Wegener s granulomatosis and the perinuclear type (panca), which indicates a range of various diseases. The differentiation of panca from antibodies against cell nuclei (ANA) is often difficult. Therefore, HEp-2 cells are used as an additional substrate (possibly with sedimented granulocytes). Primate liver is also suitable: the cell nuclei of hepatocytes and granulocytes present in the sinusoids are in the same field of view. If ANA and panca occur together, the granulocytes show a much brighter fluorescence than the hepatocyte nuclei. Thanks to EUROIMMUN BIOCHIPs it is not necessary to incubate human epithelial cells on a second slide in parallel for the exclusion of cell nucleus antibodies, since all substrates are present in one and the same test field. A fourth BIOCHIP with formalin-fixed human granulocytes detects a large proportion of the diagnostically relevant antibodies against myeloperoxidase, whereas other panca (which are particularly important in gastroenterology) and almost all antibodies against cell nuclei (whose differentiation is a separate chapter in autoantibody diagnostics) are generally completely suppressed. With the initial dilution of 1:10 recommended by EUROIMMUN for the indirect immunofluorescence test, some antibodies with a low titre, predominantly against PR3, are not detected. Thus, the prevalence for patients with Wegener s granulomatosis in IFT is between 80 and 90% (canca). With the EUROIMMUN Anti-PR3 Capture ELISA the prevalence can be increased to 92%, detecting Wegener s granulomatosis in many individuals in whom the disease had not yet established itself at the time of examination or where it is currently showing a low clinical activity. However, due to the fact that such findings mostly have no therapeutic significance for these patients, the cost-effective strategy presented in the above scheme is acceptable in general laboratory diagnostics. But when clinical symptoms and laboratory results are contradictory, it is always advisable to use all available methods simultaneously. ANA: anti-nuclear antibodies BPI: bactericidal permeability increasing protein canca: anti-neutrophil cytoplasmic antibodies, cytoplasmic type CD: Crohn s disease CSS: Churg-Strauss syndrome EL: elastase EOH: ethanol HCHO: formalin HEp-2: human epithelial cells IFT: immunofluorescence test LF: lactoferrin MPA: microscopic polyangiitis MPO: myeloperoxidase PAN: polyarteritis nodosa panca: anti-neutrophil cytoplasmic antibodies, perinuclear type PR3: proteinase 3 PSC: primary sclerosing cholangitis RA: rheumatoid arthritis SLE: systemic lupus erythematosus UC: ulcerative colitis WG: Wegener s granulomatosis 45

46 Antibodies against Endomysium and Gliadin EUROIMMUN Products for the Determination of Autoantibodies Primate liver and gliadin BIOCHIP: antibodies against endomysium and gliadin. Indirect Immunofluorescence Test: EUROPLUS Primate Liver and Gliadin BIOCHIPs Detection of antibodies against endomysium and gliadin. Indications: gluten-sensitive enteropathy (celiac disease, non-tropical sprue), Duhring s herpetiform dermatitis. Initial dilution 1 : 10; conjugate class anti-human IgA, FITC-labelled. Autoantibodies against endomysium react with many types of tissue, e.g. primate oesophagus. The most suitable substrate, however, is primate liver: in the case of a positive sample, filamentous linings of the intralobular sinusoids react. With the gliadin-coated BIOCHIP, antibodies against gliadin can be analyzed in one and the same test procedure. Both anti-endomysium antibodies and antibodies against gliadin (class IgA) are reliable serological markers for an active gluten-sensitive enteropathy. Therefore, their determination can in many cases replace endoscopy and biopsy. Formats FA 1914-####-1 A page 135 Incubated ELISA Anti-Gliadin (GAF-3X). Microplate ELISA: Anti-Gliadin (GAF-3X) Monospecific detection of antibodies against gliadin. Indications: gluten-sensitive enteropathy (celiac disease, non-tropical sprue), Duhring s herpetiform dermatitis. Serum dilution 1 : 200; conjugate class anti-human IgA or IgG, POD-labelled. 3-point calibration. Identical incubation conditions and times: the investigation of IgA and IgG antibodies can be combined without difficulty on one and the same microplate. Antigen: Gliadin-analogue fusion peptide (GAF-3X). The quantitative determination of antibodies against gliadin is very suitable for monitoring the progress of the disease, compliance with a gluten-free diet, or a gluten tolerance test. Formats EV A or G page 89 Microplate ELISA: Anti-Tissue Transglutaminase (Endomysium) Monospecific detection of antibodies against tissue transglutaminase. Indications: gluten-sensitive enteropathy (celiac disease, non-tropical sprue), Duhring s herpetiform dermatitis. Serum dilution 1 : 200; conjugate class anti-human IgA or IgG, POD-labelled. 3-point calibration, quantitative. Antigen: recombinant, expression with the baculovirus vector in insect cells. Incubated ELISA Anti-Tissue Transglutaminase (Endomysium). Formats EA A or G page 83 46

47 EUROIMMUN Products for Infectious Serology EUROIMMUN PRODUCTS FOR INFECTIOUS SEROLOGY 47

48 Antibodies against Borrelia/TBE Virus Indirect Immunofluorescence Test: EUROPLUS Anti-Borrelia afzelii, Borrelia burgdorferi, VlsE and OspC Antigen EUROIMMUN Products for Infectious Serology Antibodies against Borrelia afzelii, VlsE (top), Borrelia burgdorferi and OspC (bottom). Formats FI 2136-####-1 G or M page 139 Sensitive screening test for the detection of anti-borrelia antibodies. Indications: erythema chronicum migrans, lymphadenosis cutis benigna, lymphocytic meningoradiculitis, carditis, arthritis, acrodermatitis chronica atrophicans, neuroborreliosis. Initial dilution 1 : 10 (IgM), 1 : 100 (IgG). If antibodies against Borrelia afzelii or Borrelia burgdorferi are present, a distinct fluorescence of the bacteria in the smear is obtained. With the VlsE or OspC coated BIOCHIPs antibodies against the highly specific and highly sensitive marker antigens VlsE (IgG) or OspC (IgM) can be determined monospecifically in one and the same test procedure. If these antigens fluoresce the antibody result is positive even if the bacteria smears show a negative reaction. Thus, the BIOCHIP Mosaic helps to increase specificity and sensitivity in Borrelia diagnostics. The BIOCHIP can be supplemented as required using further substrates, e.g. Borrelia burgdorferi sensu stricto (strains CH or USA) and TBE virus infected cells. Incubated ELISA Anti-Borrelia plus VlsE. Microplate ELISA: Anti-Borrelia plus VlsE Sensitive screening test for the detection of anti-borrelia antibodies. Indications: erythema chronicum migrans, lymphadenosis cutis benigna, lymphocytic meningoradiculitis, carditis, arthritis, acrodermatitis chronica atrophicans, neuroborreliosis. Serum dilution 1 : 100; conjugate class anti-igg, anti-igm or anti-igm (VlsE: -IgG only), POD-labelled. 3-point calibration (IgG and IgM). Identical incubation conditions and times: all tests can be combined without difficulty on one and the same microplate. Antigens: extract of Borrelia-burgdorferi sensu stricto, Borrelia garinii and Borrelia afzelii (whole antigen) / recombinant VlsE from Borrelia burgdorferi sensu stricto. VlsE (variable major protein-like sequence, expressed) is a newly characterized surface protein of Borrelia which is expressed exclusively in vivo and which contains conserved and highly immunogenic epitopes. IgM test kit (Anti-Borrelia) includes IgG/RF absorbent in sample buffer for IgG absorption in preparation for the determination of specific IgM class antibodies. Formats EI G or M page 85 Microplate ELISA: Anti-TBE Virus Sensitive screening test for the detection of anti-tbe virus antibodies. Indication: Tick-borne encephalitis (TBE). Serum dilution 1 : 100; conjugate class anti-igg or anti-igm, POD-labelled. 3-point calibration (IgG and IgM). Identical incubation conditions and times: both tests can be combined without difficulty on one and the same microplate. Antigen: native, strain K23. IgM test kit includes IgG/RF absorbent in sample buffer for IgG absorption in preparation for the determination of specific IgM class antibodies. Incubated ELISA Anti-TBE Virus. Formats EI G or M page 87 48

49 Antibodies against Borrelia/TBE Virus EUROLINE-WB: Anti-Borrelia (Whole Antigen plus VlsE) Specific confirmatory test for the detection of antibodies against Borrelia. Indications: erythema chronicum migrans, lymphadenosis cutis benigna, lymphocytic meningoradiculitis, carditis, arthritis, acrodermatitis chronica atrophicans, neuroborreliosis. Serum dilution 1 : 50; conjugate class anti-igg or anti-igm, AP-labelled. Antigens: SDS extract of a Borrelia afzelii strain. EUROLINE-WB is a combination of westernblot and line blot techniques. An SDS extract of a Borrelia afzelii strain is electrophoretically separated according to molecular mass and transferred onto a nitrocellulose membrane. A membrane chip coated with highly purified recombinant VlsE-Antigen is then added to the westernblot strips. By additionally determining antibodies against VlsE the serological hit rate can be increased by 20% compared to whole extract Westernblots and by 30% compared to recombinant antigen Westernblots. Of all recombinant antigens, VlsE possesses the highest sensitivity for the detection of a Borrelia infection. Over 85% of IgG-positive sera could be identified at a glance by assessing the VlsE band. VlsE allows detection of antibodies against all Borrelia species, and the risk of a false negative reaction due to species differences is ten times lower. VlsE p 83 Incubated EUROLINE-WB Anti-Borrelia. Formats DY G or M page 79 p 41, Flag. p 39, Bmp A p 31, Osp A p 30 p 25, Osp C p p 17 Control band EUROIMMUN Products for Infectious Serology Westernblot: Anti-Borrelia burgdorferi/b. garinii/b. afzelii Specific confirmatory test for the detection of antibodies against the humanpathogen genospecies of Borrelia burgdorferi sensu lato. Indications: erythema chronicum migrans, lymphadenosis cutis benigna, lymphocytic meningoradiculitis, carditis, arthritis, acrodermatitis chronica atrophicans, neuroborreliosis. Serum dilution 1 : 50; conjugate class anti-igg or anti-igm, AP-labelled. Antigens: SDS extract of a Borrelia burgdorferi strain. Bands from all specific antigens are included and clearly separated. Test strips can be automatically incubated and evaluated using the systems EUROBlotMaster und EUROLineScan (see page 28). p 83 p 41, Flag. p 39, Bmp A p 34, Osp B p 31, Osp A p 25, Osp C p 21/22 p 18 Alignment bar Control band Incubated Westernblot Anti-Borrelia burgdorferi. Formats DY G or M page 79 Automated Evaluation of Incubated Membrane Strips with the System EUROLineScan The program EUROLineScan from EUROIM- MUN has been developed to enable quantitative evaluation of membrane based test systems, facilitate management of data, and provide detailed documentation of results tasks which have until now required considerable time. First, the incubated test strips are scanned using a flatbed scanner or camera system. EUROLineScan recognizes the position of the strips, even if they have been placed inexactly, identifies the bands, and measures their intensity. The automated evaluation can be monitored, and it is possible to supplement the data manually. The results are then saved together with the image data. It is no longer necessary to archive (potentially infectious) incubated test strips. A separate results sheet can be produced for each patient. 49

50 Antibodies against Epstein-Barr Virus (EBV) Indirect Immunofluorescence Test: BIOCHIP Sequence EBV EUROIMMUN Products for Infectious Serology Gold standard for the detection of antibodies against the antigens EBV-CA (Epstein-Barr virus capsid antigen), EBV-EA (Epstein-Barr early antigen) and EBNA (Epstein-Barr nuclear antigen). Indications: infectious mononucleosis, Burkitt s lymphoma, nasopharyngeal carcinoma. For each patient (format 1001) 1 slide is incubated according to the following scheme: Substrate 1 st incubation Field A EBV-CA (IgG) Serum sample 1:10 Field B EBV-CA (IgG) Serum sample 1:10 Field C EBV-CA (IgM) Serum sample 1:10 Field D EBV-EA (IgG) Serum sample 1:10 Field E EBNA (IgG) Serum sample 1:10 2 nd incubation PBS 8 M urea solution PBS PBS Complement 3 rd incubation FITC-antihuman IgG FITC-antihuman IgG FITC-antihuman IgM FITC-antihuman IgG FITC-antihuman C3c Antibodies against Epstein-Barr virus: anti-ebv- CA (top), anti-ebna (middle), anti-ebv-ea (bottom). Formats FI 2799-####-1 X page 152 Class IgG antibodies against EBV-CA indicate an EBV infection. An at least twofold increase in titer and the absence of antibodies against EBNA at the same time characterize the early stage of an infection. Class IgM antibodies against EBV-CA as well as antibodies against EBV-EA may also occur in a primary infection, but are not obligatory. If antibodies against EBNA are present, the late phase of an EBV infection has usually been reached. If a primary EBV infection cannot be differentiated with confidence from a relapse or reinfection, the determination of the antibody avidity using a modified immunofluorescence test as an additional parameter can be beneficial (see incubation scheme). Therefore, a further incubation with urea solution (ZF ) must be carried out. The detection of low-avidity antibodies against EBV- CA proves a primary infection. IgG absorbtion in preparation for the determination of IgM antibodies: page 56. Further anti-ebv test kits for indirect immunofluorescence: Substrate Substrate EBV-CA FI 2791-#### G EBV-EA FI 2795-#### G EBV-CA FI 2791-#### M EBV-CA & EBV-EA FI 2791-####-2 G EBNA FI 2793-#### G (2 BIOCHIPs per field) Microplate ELISA: Anti-EBV-CA, Anti-EBNA-1, Anti-EBV-EA Incubated ELISA Anti-EBNA-1. (anti-ebna-1) Formats EI G page 89 Specific confirmatory test for antibodies against EBV-CA, EBNA-1 or EBV-EA. Indications: infectious mononucleosis, Burkitt s lymphoma, nasopharyngeal carcinoma. Serum dilution 1 : 100; conjugate class anti-iga, -IgG or IgM, POD-labelled. 1-point calibration, semi-quantitative (IgA, IgM) or 3-point calibration, quantitative (IgG). Identical incubation conditions and times: all tests can be combined without difficulty on one and the same microplate. EBV-CA: native antigen, purified by affinity chromatography; EBNA-1 and EBV-EA: recombinant antigen. IgM test kit includes IgG/RF absorbent in sample buffer for IgG absorption in preparation for the determination of specific IgM class antibodies. Available individual ELISA: Antigen EBV-CA EBNA-1 EBV-EA EI A, G or M EI G EI A, G or M 50

51 Antibodies against Epstein-Barr Virus (EBV) Determination of Low-Avidity Antibodies against EBV-CA An alternative principle for the serological diagnosis of fresh infections with EBV has been established by investigating the antibody avidity. The first reaction of the immune system following an infection is the formation of low-avidity antibodies. As the infection proceeds, increasingly antigen-adapted IgG is formed, and avidity grows. As long as high-avidity IgG is not yet detected in the serum, it can be assumed that the infection is still in an early stage. To identify low-avidity antibodies against EBV-CA in a patient s serum, two microplate ELISA or immunofluorescence tests are performed in parallel: one test is carried out in the conventional way, the other one includes urea treatment between incubations with patient s serum and peroxidase-labelled anti-human IgG, resulting in the detachment of low-avidity antibodies from the antigens. Low-avidity antibodies against EBV-CA are present if the ELISA extinction is significantly reduced by urea treatment. For an objective interpretation, the relative avidity index (RAI) can be calculated out of the measured values with and without urea incubation. With the immunofluorescence test the presence of low-avidity antibodies has been proved if the test using urea treatment gives a far weaker fluorescence than the two-step test. Number of Patients RAI = E with urea E without urea Relative Avidity Index (RAI) in % Formats EI G page 88 Primary Infection Previous Infection Avidity of antibodies against EBV-CA (IgG) EUROIMMUN Products for Infectious Serology EUROLINE: EBV Profile 2 Differentiation of antibodies against Epstein-Barr virus antigens. Indications: infectious mononucleosis, Burkitt s lymphoma, nasopharyngeal carcinoma. Serum dilution 1 : 100; conjugate class anti-human IgG or IgM, AP-labelled. With the EUROLINE EBV Profile 2, five different antibodies can be determined: antibodies against VCA gp125, VCA p19, EBNA-1, p22, EA-D. Recombinant antigens (exception: VCA gp125, native, purified by affinity chromatography). EBNA-1 (IgG) negative und VCA (IgG and IgM) positive: acute (fresh) infection. EBNA-1 (IgG) and VCA (IgG) positive and VCA (IgM) negative: late phase of infection. EBNA-1 (IgG) negative, but band p22 (IgG) and VCA (IgG) positive: late phase of infection with loss of anti-ebna-1. Test strips can be automatically incubated and evaluated using the systems EUROBlotMaster und EUROLineScan (see page 28). VCA gp125 VCA p19 EBNA-1 p22 EA-D Control Incubated EUROLINE EBV Profile 2. Formats DN G or M page 77 Westernblot: Anti-EBV Specific confirmatory test for the detection of antibodies against Epstein-Barr virus antigens, differentiation of antibodies against Epstein-Barr virus antigens. Indications: infectious mononucleosis, Burkitt s lymphoma, nasopharyngeal carcinoma. Serum dilution 1 : 50; conjugate class anti-igg or anti-igm, AP-labelled. Antigens: whole antigen, SDS extract. Bands from all specific antigens are included and clearly separated. EBNA-1 (IgG) negative und VCA (IgG and IgM) positive: acute (fresh) infection. EBNA-1 (IgG) and VCA (IgG) positive and VCA (IgM) negative: late phase of infection. EBNA-1 (IgG) negative, but band p22 (IgG) and VCA (IgG) positive: late phase of infection with loss of anti-ebna-1. Test strips can be automatically incubated and evaluated using the systems EUROBlotMaster und EUROLineScan (see page 28). VCA 125 VCA 65 VCA 40/41/42 VCA 33 VCA 22 Incubated Westernblot Anti-EBV. EA R EBNA-1 EA D Control band Formats DY G or M page 80 51

52 Antibodies against Helicobacter pylori Indirect Immunofluorescence Test: Anti-Helicobacter pylori EUROIMMUN Products for Infectious Serology Antibodies against Helicobacter pylori. Sensitive screening test for the detection of antibodies against Helicobacter pylori. Indications: gastritis, ulcus ventriculi et duodeni. Late consequences: MALT lymphomas and adenocarcinomas. Initial dilution 1 : 10 (IgM), 1 : 100 (IgG), 1 : 32 (IgA). If antibodies against Helicobacter pylori are present, a distinct fluorescence of the bacteria in the smear is obtained. A positive IgA result correlates well with the activity of a gastritis. An increased IgG antibody titer is considered to be a marker for chronic infections. A significant drop in the IgG antibody titer about 6 months after therapy is a sign of success. The BIOCHIP can be supplemented as required with further substrates, e.g. other infectious agents or tissue sections of primate stomach. Formats FI 2080-#### A or G page 137 Incubated ELISA Anti-Helicobacter pylori. Microplate ELISA: Anti-Helicobacter pylori Sensitive screening test for the detection of antibodies against Helicobacter pylori. Indications: gastritis, ulcus ventriculi et duodeni. Late consequences: MALT lymphomas and adenocarcinomas. Serum dilution 1 : 100; conjugate class anti-iga or anti-igg, POD-labelled. Antibodies against Helicobacter pylori antigens can be determined quantitatively in RU/ml. 1-point calibration, semi-quantitative (IgA) or 3-point calibration, quantitative (IgG). Identical incubation conditions and times: both tests can be combined without difficulty on one and the same microplate. Native antigens. Formats EI A or G page 85 p 120, CagA p 95, VacA p 66, UreB p 33 p 30 p 29, UreA p 26 p 19, OMP p 17 Alignment bar Incubated Westernblot Anti-Helicobacter pylori. Formats DY A or G page 79 Control band Westernblot: Anti-Helicobacter Pylori Specific confirmatory test for the detection of antibodies against Helicobacter pylori. Indications: gastritis, ulcus ventriculi et duodeni. Late consequences: MALT lymphomas and adenocarcinomas. Serum dilution 1 : 50; conjugate class anti-iga or anti-igg, AP-labelled. Antigens: antigen extract from a particularly suitable Helicobacter pylori strain. Bands from all specific antigens are included and clearly separated. Test strips can be automatically incubated and evaluated using the systems EUROBlotMaster und EUROLineScan (see page 28). 52

53 Antibodies against Herpes Simplex Virus (HSV) Indirect Immunofluorescence Test: BIOCHIP Mosaic HSV-1/HSV-2 Sensitive screening test for the detection of antibodies against herpes simplex viruses. Indication: herpes simplex. Initial dilution 1 : 10 (IgM), 1 : 100 (IgG). If antibodies against herpes simplex-2 virus are present in the sample, a typical fluorescence of the infected cells is obtained mainly in the outspread cytoplasm, less in the cell nuclei. As HSV-1 and HSV-2 are morphologically and immunologically closely related, cross-reactions can occur. Differentiation may be attempted by testing a serum against both antigen substrates and comparing the titers. The BIOCHIP Mosaic can be supplemented as required with further substrates, e.g. other infectious agents. Anti-HSV individual tests for indirect immunofluorescence: Substrate HSV-1 HSV-2 HSV-1 and -2 FI 2531-#### G or M FI 2532-#### G or M FI 2531-####-1 G or M Antibodies against HSV-1 and HSV-2. Formats FI 2531-####-1 G or M page 145 EUROIMMUN Products for Infectious Serology Microplate ELISA: Anti-HSV-1, Anti-HSV-2 Specific confirmatory tests for antibodies against HSV-1 or HSV-2. Indication: herpes simplex. Serum dilution 1 : 100; conjugate class anti-igg or anti-igm, POD-labelled. 1-point calibration, semiquantitative (IgM) or 3-point calibration, quantitative (IgG). Identical incubation conditions and times: all tests can be combined without difficulty on one and the same microplate. Antigens: type-specific glycoproteins C1 or G2, purified by affinity chromatography. Cross-reactions do not occur. IgM test kit includes IgG/RF absorbent in sample buffer for IgG absorption in preparation for the determination of specific IgM class antibodies. Available individual ELISA: Antigen HSV-1 HSV-2 HSV-1/2-Pool EI G or M EI G or M EI G or M Incubated ELISA Anti-HSV-1. (anti-hsv-1) Formats EI G or M page 86 EUROLINE-WB: Anti-HSV Specific confirmatory test for the differentiation of antibodies against HSV-1 and HSV-2. Indication: herpes simplex. Serum dilution 1 : 50; conjugate class anti-igg or anti-igm, AP-labelled. EUROLINE-WB is a combination of westernblot and line blot techniques. Proteins from an SDS extract of HSV-1 are electrophoretically separated according to molecular mass and transferred onto a nitrocellulose membrane. A membrane chip coated with HSV-2 type-specific glycoprotein G2 (gg 2), purified by affinity chromatography, is then added to the westernblot strips. Bands from all specific antigens are included and clearly separated. The gg 2 band allows the simple differentiation between HSV-1 and HSV-2 infections. Test strips can be automatically incubated and evaluated using the systems EUROBlotMaster und EUROLineScan (see page 28). gc 1 gb 1 gd 1 gg 2 Alignment bar Control band Incubated EUROLINE-WB Anti-HSV. Formats DY G or M page 80 53

54 BIOCHIP Mosaics for Infectious Serology (For formats see pages ) EUROIMMUN Products for Infectious Serology FI G FI G RESPIRATORY TRACT PROFILE 1 EXANTHEMA PROFILE 1 IgG IgM IgG IgM Field A 1 : 10 1 : 10 Field A 1 : 10 1 : RSV 1. HHV-6 2. Adenovirus type 3 2. Rubella virus* 3. Influenza virus type A (H1N1) 3. Measles virus 4. Influenza virus type A (H3N2) 4. Mumps virus Field B 1 : 10 1 : 10 Field B 1 : 10 1 : Influenza virus type B 5. VZV 6. Parainfluenza virus type 1 6. EBV-CA** 7. Parainfluenza virus type 2 7. EBV-EA 8. Parainfluenza virus type 3 8. Treponema pallidum Field C 1 : 10 1 : 10 Field C 1 : : Parainfluenza virus type 4 9. HSV Bordetella pertussis** 10. HSV Bordetella parapertussis** 11. Coxsackie virus type B1 12. Mycoplasma pneumoniae 12. Coxsackie virus type A9 Field D 1 : : 10 Field D 1 : : Coxsackie virus type B1 13. Echo virus type Coxsackie virus type A7 14. Borrelia afzelii 15. Echo virus type Borrelia burgdorferi sensu stricto (CH) 16. Chlamydia pneumoniae 16. Borrelia garinii Field E 1 : : 100 Field E 1 : : Haemophilus influenzae*, ** 17. CMV 18. Klebsiella pneumoniae* 18. Candida albicans** 19. Legionella pneumophila serotype 1*, ** 19. Candida krusei*, ** 20. Legionella pneumophila serotype 12*, ** 20. Candida tropicalis*, ** FI G FI G LYMPHADENITIS PROFILE 1 CENTRAL NERVOUS SYSTEM PROFILE 1 IgG IgM IgG IgM Field A 1 : 10 1 : 10 Field A 1 : 10 1 : HIV-1* 1. Rubella virus* 2. HIV-2* 2. Measles virus 3. HHV-6 3. Mumps virus 4. Rubella virus* 4. VZV Field B 1 : 10 1 : 10 Field B 1 : 10 1 : Measles virus 5. Adenovirus type 3 6. Mumps virus 6. EBV-CA** 7. Adenovirus type 3 7. Treponema pallidum 8. Parainfluenza virus type 1 8. Toxoplasma gondii** Field C 1 : 10 1 : 10 Field C 1 : : EBV-CA** 9. HSV EBV-EA 10. HSV Toxoplasma gondii** 11. Coxsackie virus type B1 12. Treponema pallidum 12. Coxsackie virus type A7 Field D 1 : : 10 Field D 1 : : HSV Echo virus type HSV Borrelia afzelii 15. CMV** 15. Borrelia burgdorferi sensu stricto (CH) 16. Coxsackie virus type B5 16. Borrelia garinii Field E 1 : : 10 Field E 1 : : Coxsackie virus type A9 17. CMV 18. Bartonella henselae** 18. Haemophilus influenzae*, ** 19. Chlamydia trachomatis** 19. Listeria monocytogenes 1/2a* 20. Chlamydia pneumoniae 20. Listeria monocytogenes 4b* * For clinical evaluation the results must be confirmed with a CE approved test. ** For practical reasons the recommended incubation differs from the standard incubation for this substrate. BIOCHIP Mosaics containing fewer substrates can be produced upon request. 54

55 BIOCHIP Mosaics for Infectious Serology (For formats see pages ) FI G FI G MYOCARDITIS PROFILE 1 INFECTARTHRITIS PROFILE 1 IgG IgM IgG IgM Field A 1 : 10 1 : 10 Field A 1 : 10 1 : Mumps virus 1. VZV 2. Adenovirus type 3 2. Influenza virus type A (H1N1) 3. Influenza virus type A (H1N1) 3. Influenza virus type A (H3N2) 4. Influenza virus type A (H3N2) 4. Influenza virus type B Field B 1 : 10 1 : 10 Field B 1 : 10 1 : Influenza virus type B 5. Yersinia enterocolitica O:3*, ** 6. Parainfluenza virus type 1 6. Yersinia enterocolitica O:6*, ** 7. Parainfluenza virus type 2 7. Yersinia enterocolitica O:9*, ** 8. Mycoplasma pneumoniae 8. Toxoplasma gondii** Field C 1 : : 10 Field C 1 : : CMV** 9. Borrelia afzelii 10. Coxsackie virus type B1 10. Borrelia burgdorferi sensu stricto (CH) 11. Coxsackie virus type A Borrelia garinii 12. Echo virus type Chlamydia trachomatis** Field D 1 : : Borrelia afzelii 14. Borrelia burgdorferi sensu stricto (CH) 15. Borrelia garinii 16. Chlamydia pneumoniae EUROIMMUN Products for Infectious Serology FI G FI G GASTROINTESTINAL TRACT PROFILE 1 ACCOMPANYING HEPATITIS PROFILE 1 IgG IgM IgG IgM Field A 1 : 10 1 : 10 Field A 1 : 10 1 : Adenovirus type 3 1. Adenovirus type 3 2. Yersinia enterocolitica O:3*, ** 2. EBV-CA** 3. Yersinia enterocolitica O:6*, ** 3. EBV-EA 4. Yersinia enterocolitica O:9*, ** 4. Toxoplasma gondii** Field B 1 : : 10 Field B 1 : : Coxsackie virus type B3 5. HSV-1 6. Coxsackie virus type A7 6. HSV-2 7. Echo virus type 7 7. CMV** 8. Campylobacter jejuni*, ** 8. Coxsackie virus type B5 Field C 1 : : 100 Field C 1 : 10 1 : Campylobacter coli*, ** 9. Coxsackie virus type A9 10. Helicobacter pylori** 10. Echo virus Typ Klebsiella pneumoniae* 11. Echinococcus granulosus** 12. Candida albicans** FI G FI G OPHTHALMOLOGY PROFILE 1 PREGNANCY PROFILE 1 IgG IgM IgG IgM Field A 1 : 10 1 : 10 Field A 1 : 10 1 : Measeles virus 1. Rubella virus* 2. VZV 2. Toxoplasma gondii** 3. Adenovirus type 3 3. HIV-1* 4. Toxoplasma gondii** 4. HIV-2* Field B 1 : : 10 Field B 1 : : HSV-1 5. Chlamydia trachomatis** 6. HSV-2 6. CMV** 7. Coxsackie virus type A24 7. HSV-2 8. Chlamydia trachomatis** 8. VZV** * For clinical evaluation the results must be confirmed with a CE approved test. ** For practical reasons the recommended incubation differs from the standard incubation for this substrate. BIOCHIP Mosaics containing fewer substrates can be produced upon request. 55

56 IgG Absorption in Preparation for the Determination of Specific IgM Class Antibodies Principle EUROIMMUN Products for Infectious Serology rheumatoid factor IgG Before a patient s serum is tested for specific antibodies of the IgM class, antibodies of class IgG must be removed by ultracentrifugation, chromatography or immunoabsorption. Specifically bound IgG would displace IgM from the antigen leading to false IgM negative test results. Moreover, the absorption prevents any IgM class rheumatoid factors present from reacting with specifically bound IgG and thus leading to false IgM positive test results. Indication: an IgG absorption of serum samples should always be performed for all IgM antibody determinations in infectious serology before incubating the sera. absorbent EUROSORB IgG/RF Absorbent for Indirect Immunofluorescence EUROSORB IgG/RF Absorbent. Functional principle: the EUROSORB reagent contains an anti-human IgG antibody preparation from goat. Immunoglobulin G of a serum or plasma sample is bound with high specificity by these antibodies and precipitated. If the sample also contains rheumatoid factors, these will be absorbed by the anti-human IgG/ IgG complex. Incubation time of the sample with the reagent is 15 minutes. A centrifugation step for a subsequent investigation by immunofluorescence is recommended. All IgG subclasses are bound and precipitated by the anti-human IgG antibodies. Human serum IgG in concentrations of up to 15 mg/ml and rheumatoid factors are completely removed by the absorbent (average serum IgG concentration in adults: 12 mg/ml). The recovery rate of the IgM fraction is almost 100%. One unit contains 4.5 ml absorbent, sufficient for the absorption of 100 serum samples. Formats ZF page

57 EUROIMMUN PRODUCTS FOR ALLERGOLOGY EUROIMMUN Products for Allergology 57

58 Antibodies of Class IgE against Allergens EUROASSAY: Specific IgE EUROIMMUN Products for Allergology Incubated EUROASSAY Allergy Profile Inhalation. (Inhalation) Formate and Price DE 3110-#### E Page 76 Determination of specific IgE in serum. Indication: Clarification of allergic reactions to inhalation allergens, food allergens, insect venoms and latex and latex-related allergens. Serum dilution: undiluted; conjugate class anti-ige (monoclonal), AP-labelled. Antibodies against up to 7 allergens per field and 35 allergens per slide can be simultaneously monospecifically detected. EUROASSAY profiles with different allergen compositions are available for various test requirements: inhalation, food, domestic animals, insect venoms, latex, latex plus. grasses trees weeds mites animal hair mould spores indicators Incubated EUROLINE Allergy Profile Inhalation. (Inhalation) Format and Price DP E Page 77 EUROLINE: Specific IgE Determination of specific IgE in serum. Indication: Clarification of allergic reactions to inhalation allergens, food allergens and cross-reactive allergens (pollen-associated food allergies). Serum dilution: undiluted (or 1 : 10); conjugate class anti-ige (monoclonal), APlabelled. Calibration: 3 indicator bands on each strip for semiquantitative evaluation. Antibodies against up to 20 allergens per strip can be simultaneously monospecifically detected. EUROLINE profiles with different allergen compositions are available for various test requirements: atopy, inhalation, food and cross reactions. The program EUROLineScan from EUROIMMUN has been developed to enable quantitative evaluation of EUROLINE analyses, facilitate management of data, and provide detailed documentation of results. The incubated EUROLINE test strips are scanned using a flatbed scanner. EUROLineScan recognizes the position of the strips, even if they have been placed inexactly, identifies the bands, and measures their intensity. EUROIMMUN Microplate ELISA: Total IgE Determination of the total IgE concentration in serum. Indications: Differentiation between allergic and intrinsic asthma, between allergic and vasomotor rhinitis, and between atopic and seborrhoic dermatitis. Serum dilution 1 : 10; conjugate class anti-ige (monoclonal), POD-labelled. One microplate well incubated per patient. 4-point calibration, quantitative. Coating: anti-human IgE, polyclonal. The Total IgE ELISA serves as a screening test for allergy diagnostics and provides an indication for the presence of an allergic reaction. Incubated ELISA Total IgE. Format and Price EV E Page 89 58

59 Antibodies of Class IgE against Allergens Allercoat 6 Microplate ELISA: specific IgE Determination of allergen-specific IgE concentrations in serum. Indication: identification of allergic reactions to more than 600 different allergens and allergen mixtures. Serum dilution: undiluted, conjugate class anti-human IgE, AP-labelled. One microplate well per allergen/allergen mixture is incubated for each patient. Calibration: 6-point calibration, quantitative; using reference preparation 2 IRP 75/ 502 from the WHO. The allergens are coupled to paper rings and can be flexibly configured for each sample according to the analysis. Customized pre-assembled microplates with individual allergy parameters are available on request (Order no.: EP ). Orders can be made online with the provided software. Please contact us! A light table and special evaluation software are available to supplement the simple manual Allercoat 6 ELISA procedure. Allercoat 6 ELISA are automatable. Allercoat TM 6 ELISA. Format and Price EP ####-0110 E Page EUROIMMUN Products for Allergology Individual equipment with allergen rings allergen rings Pipette: 50 µl per well undiluted samples ; ;;;; Incubate: 60 min, 37 C Wash: Pipette: 300 µl wash buffer per well 50 µl per well 4x ;; ;; ;;;;;;;; enzyme conjugate ;; ; ;;;;;;; Incubate: 60 min, 37 C Wash: Pipette: 300 µl wash buffer per well 100 µl per well 8x ;;; ;;; ;;;;;;;;;;;;; ; chromogen-/ substrate sol. Fitting of allergen rings into microplate wells Incubate: 30 min, 37 C Pipette: 100 µl per well ;;;; ;; yy stop ;; ;; ;; ;; yy Evaluate: photometric measurement at a wavelength of 405 ;; yy ;; ;; yy ;; ;; ;; yy 59

60 ORDER INFORMATION AND PRODUCT DATA FI G Format 1601: 16 single test strips 1208: 12 microplate strips with 8 wells each 9601: 96 individual break-apart wells (12 microplate strips with 8 wells each) 5001: 50 individual tubes 0001: 100 individual tubes 1003: 10 slides with 3 fields each 1005: 10 slides with 5 fields each 2005: 20 slides with 5 fields each 1010: 10 slides with 10 fields each 1050: 10 slides with 50 fields each 1096: 10 slides with 96 fields each 1001: 10 slides to be incubated with 1 patient serum each 1002: 10 slides to be incubated with 2 patient sera each Immunoglobulin Class A: IgA E: IgE G: IgG Product Code M: IgM O: IgGM Product Classification P: Polyvalent (IgM) AF: Fluorescence-labelled antibodies for EUROIMMUN IIFT X: low-avide antibodies of class IgG CA: Control for EUROIMMUN IIFT (autoimmunity) H: high-avide antibodies of class IgG CI: Control for EUROIMMUN IIFT (infectious serology) CV: Control for EUROIMMUN IIFT (determination of further antibodies) CW: Control for EUROIMMUN Westernblot/EUROLINE-WB DA: EUROASSAY test system (autoimmunity) DE: EUROASSAY test system (allergology) DL: EUROLINE test system (autoimmunity) DN: EUROLINE test system (infectious serology) DP: EUROLINE test system (allergology) DW: Westernblot/EUROLINE-WB test system (autoimmunity) DY: Westernblot/EUROLINE-WB test system (infectious serology) EA: Microplate ELISA test system (autoimmunity) EI: Microplate ELISA test system (infectious serology) EP: Microplate ELISA test system (allergology) EQ: Microplate ELISA test system (serum proteins and tumour markers) EV: Microplate ELISA test system (determination of further antibodies) FA: Test system for indirect immunofluorescence (autoimmunity) FB: Single slides for indirect immunofluorescence (autoimmunity) FI: Test system for indirect immunofluorescence (infectious serology) FK: Single slides for indirect immunofluorescence (infectious serology) FV: Test system for indirect immunofluorescence (determination of further antibodies) FX: Single slides for indirect immunofluorescence (determination of further antibodies) RA: Radioimmunoassay (autoimmunity) RD: Radioimmunoassay (direct detection of autoantigens, hormone determination) ZF: Further reagents for EUROIMMUN IIFT ZZ: Other items for EUROIMMUN IIFT When placing an order, please indicate quantity, order number and designation of the required product. Examples: 2 x FA liver, monkey (2 test systems with 10 slides each, 10 fields per slide) 1 x FA kidney, rat / stomach, rat (1 test system with 20 slides, 5 fields per slide) 2 x FI G Measles virus (2 IgG class test systems with 10 slides each, 3 fields per slide) Test systems comprise all reagents needed to perform the serological investigation, for diagnostics in indirect immunofluorescence, e.g. slides, FITC-labelled antibodies against human immunoglobulin, positive and negative control sera (not available for some products) as well as embedding medium, cover glasses, sachets of PBS and Tween 20. EUROSORB for the determination of IgM class antibodies is not included in the immunofluorescence test systems. Single slides are supplied with cover glasses only. Substrates consisting of cell cultures and tissues which do not appear in this catalogue can be made to specification. In addition, BIOCHIP Mosaics can be produced according to individual requirements. Apart from the customary package sizes and slide formats, special sizes are available as well. Quotations can be provided upon request. 60

61 Fluorescence-Labelled Antibodies: Fluorescein (FITC) for EUROIMMUN IIFT Antiserum Format AF FITC-labelled anti-human IgA 1.5 ml (ready for use) AF (goat) 6.0 ml (ready for use) AF FITC-labelled anti-human IgG 1.5 ml (ready for use) AF (goat) 6.0 ml (ready for use) AF FITC-labelled anti-human IgM 1.5 ml (ready for use) AF (goat) 6.0 ml (ready for use) AF FITC-labelled anti-human IgM 1.5 ml (ready for use) AF (IgA + IgG + IgM goat) 6.0 ml (ready for use) AF FITC-labelled anti-human Ig 1.5 ml (ready for use) AF (IgA + IgG goat) 6.0 ml (ready for use) AF FITC-labelled anti-human C3c 1.5 ml (ready for use) AF (goat) 6.0 ml (ready for use) AF FITC-labelled anti-human IgG 1.5 ml (ready for use) AF (goat) 6.0 ml (ready for use) primate absorbed AF FITC-labelled anti-human IgA 1.5 ml (ready for use) AF (goat) 6.0 ml (ready for use) with Evans Blue AF FITC-labelled anti-human IgG 1.5 ml (ready for use) AF (goat) 6.0 ml (ready for use) with Evans Blue AF FITC-labelled anti-human IgM 1.5 ml (ready for use) AF (goat) 6.0 ml (ready for use) with Evans Blue AF FITC-labelled anti-human IgM 1.5 ml (ready for use) AF (IgA + IgG + IgM goat) 6.0 ml (ready for use) with Evans Blue AF FITC-labelled anti-human Ig 1.5 ml (ready for use) AF (IgA + IgG goat) 6.0 ml (ready for use) with Evans Blue Fluorescence- Labelled Antibodies AF FITC-labelled anti-human C3c 1.5 ml (ready for use) AF (goat) 6.0 ml (ready for use) with Evans Blue 61

62 Controls for EUROIMMUN IIFT: Organ-Specific Autoantibodies Control (Ready for Use) Ig Class Format CA autoantibody-free control IgG 0.1 ml 5.00 (aab negative) CA antibodies against thyroid microsomes IgG 0.1 ml 5.00 and thyroglobulin (MAb+TAb control) CA antibodies against thyroid microsomes IgG 0.1 ml 5.00 (MAb control) CA antibodies against thyroglobulin IgG 0.1 ml 5.00 (TAb control) CA antibodies against pancreas islets IgG 0.1 ml 5.00 (islet cell ab control) CA antibodies against pancreas islets IgG 0.1 ml 5.00 control with indication of titer in JDF units CA antibodies against glutamic acid decarboxylase IgG 0.1 ml 5.00 (GAD ab control) CA antibodies against adrenal cortex IgG 0.1 ml 5.00 (adrenal cortex ab control) CA antibodies against ovary: theca cells IgG 0.1 ml 5.00 (ovary ab control) CA antibodies against ovary: zona pellucida IgG 0.1 ml 5.00 (zona pellucida ab control) CA * antibodies against placenta: IgG 0.1 ml 5.00 syncytiotrophoblast (placenta ab control) Controls for the Determination of Autoantibodies CA antibodies against testis: Leydig cells IgG 0.1 ml 5.00 (testis ab control) CA antibodies against spermatozoa IgG 0.1 ml 5.00 (spermatozoa ab control) CA antibodies against brain: grey matter IgG 0.1 ml 5.00 (stiff man syndrome; SMS control) CA antibodies against Purkinje cell cytoplasm IgG 0.1 ml 5.00 (Yo ab control) CA antibodies against neurone nuclei: Ri antigen IgG 0.1 ml 5.00 (Ri ab control) CA antibodies against neurone nuclei: Hu antigen IgG 0.1 ml 5.00 (Hu ab control) CA antibodies against myelin IgG 0.1 ml 5.00 (myelin ab control) CA antibodies against myelin-associated IgG 0.1 ml 5.00 glycoprotein (M ab control) CA antibodies against medullated nerves IgG 0.1 ml 5.00 (myelin sheath ab control) CA antibodies against neuroendothelium IgG 0.1 ml 5.00 (neuroendothelium ab control) CA antibodies against neurofilaments IgG 0.1 ml 5.00 (neurofilament ab control) CA antibodies against non-medullated nerves IgG 0.1 ml 5.00 (non-medullated nerves ab control) CA antibodies against granulocyte cytoplasm, IgG 0.1 ml 5.00 cytoplasmic pattern (canca control, Wegener s granulomatosis) *) Currently not available as IVD in the European Union. 62

63 Controls for EUROIMMUN IIFT: Organ-Specific Autoantibodies Control (Ready for Use) Ig Class Format CA antibodies against granulocyte cytoplasm, IgG 10 x 60 µl, ready for use CA aliquots from positive control for ANCA diagnostics 80 x 60 µl, ready for use (10 different fluorescence patterns) CA antibodies against granulocyte cytoplasm, IgG 0.1 ml 5.00 perinuclear pattern (panca control) CA antibodies against myeloperoxidase IgG 0.1 ml 5.00 (MPO ab control) CA antibodies against granulocyte cytoplasm, IgG 0.1 ml 5.00 perinuclear pattern (xanca control) CA antibodies against thrombocytes IgG 0.1 ml 5.00 (thrombocyte ab control) CA antibodies against renal glomeruli IgG 0.1 ml 5.00 (Goodpasture syndrome; GBM ab control) CA antibodies against renal tubuli IgG 0.1 ml 5.00 (TBM ab control) CA antibodies against liver-specific protein IgG 0.1 ml 5.00 (LSP ab control) CA antibodies against liver membrane IgG 0.1 ml 5.00 (LMA control) CA antibodies against bile canaliculi IgG 0.1 ml 5.00 (bile canaliculi ab control) CA antibodies against liver-kidney microsomes IgG 0.1 ml 5.00 (LKM ab control) CA antibodies against parietal cells IgG 0.1 ml 5.00 (PCA control) CA antibodies against intrinsic factor IgG 0.1 ml 5.00 (intrinsic factor ab control) CA antibodies against parietal cells + intrinsic factor IgG 0.1 ml 5.00 (PCA + intrinsic factor ab control) CA A antibodies against intestinal goblet cells IgA 0.1 ml 5.00 (ulcerative colitis; UC IgA control) CA G antibodies against intestinal goblet cells IgG 0.1 ml 5.00 (ulcerative colitis; UC IgG control) Controls for the Determination of Autoantibodies CA antibodies against pancreas acini IgG 0.1 ml 5.00 (Crohn s disease 1 control) CA antibodies against pancreas secretion IgG 0.1 ml 5.00 (Crohn s disease 2 control) CA antibodies against parotid excretory ducts IgG 0.1 ml 5.00 (parotid gland ab control) CA antibodies against striated muscles IgG 0.1 ml 5.00 (myasthenia gravis control) CA antibodies against striation IgG 0.1 ml 5.00 (heart 1 ab control) CA antibodies against intercalated discs IgG 0.1 ml 5.00 (heart 2 ab control) CA antibodies against epidermis: desmosomes IgG 0.1 ml 5.00 (pemphigus vulgaris control) CA antibodies against epidermis: basement membrane IgG 0.1 ml 5.00 (bullous pemphigoid control) CA antibodies against keratin IgG 0.1 ml 5.00 (filaggrin ab control) 63

64 Controls for EUROIMMUN IIFT: Systemic Autoantibodies Control (Ready for Use) Ig Class Format CA antibodies against cell nuclei IgG 0.1 ml 5.00 (ANA control), homogeneous pattern CA antibodies against cell nuclei (ANA control), IgG 8 aliquots concentrate 50 µl each CA homogeneous pattern 96 aliquots concentrate 50 µl each control serum with indication of titer CA antibodies against cell nuclei, IgG 20 x 60 µl, ready for use CA aliquots from positive control for ANA diagnostics 80 x 60 µl, ready for use (20 different fluorescence patterns) CA antibodies against dsdna IgG 0.1 ml 5.00 (dsdna ab control) CA antibodies against cell nuclei IgG 0.1 ml 5.00 (ANA control), nucleolar pattern CA antibodies against RNA IgG 0.1 ml 5.00 (RNA ab control) CA antibodies against cell nuclei IgG 0.1 ml 5.00 (ANA control), granular pattern CA antibodies against U1-nRNP IgG 0.1 ml 5.00 CA antibodies against Sm IgG 0.1 ml 5.00 CA antibodies against SS-A (Ro) IgG 0.1 ml 5.00 CA antibodies against SS-B (La) IgG 0.1 ml 5.00 CA antibodies against Scl-70 IgG 0.1 ml 5.00 Controls for the Determination of Autoantibodies CA antibodies against PCNA (cyclin I) IgG 0.1 ml 5.00 CA antibodies against mitosin (cyclin II) IgG 0.1 ml 5.00 CA antibodies against Sp100 (nuclear granula, IgG 0.1 ml 5.00 nuclear dots; PBC-associated) CA antibodies against Ku IgG 0.1 ml 5.00 (Ku ab control) CA antibodies against nuclear membrane IgG 0.1 ml 5.00 (lamin ab control) CA antibodies against cell nuclei IgG 0.1 ml 5.00 (ANA control), centromere pattern CA antibodies against spindle fibers (MSA-1) IgG 0.1 ml 5.00 CA antibodies against mitochondria IgG 0.1 ml 5.00 (AMA control) CA antibodies against mitochondria IgG 0.1 ml 5.00 (AMA M2 control; PBC-associated) CA antibodies against mitochondria IgG 0.1 ml 5.00 (AMA M9 control) CA antibodies against ribosomes IgG 0.1 ml 5.00 CA antibodies against Golgi apparatus IgG 0.1 ml 5.00 CA antibodies against F-actin IgG 0.1 ml 5.00 (F-actin control) CA antibodies against vimentin IgG 0.1 ml 5.00 CA antibodies against histidyl-trna synthetase IgG 0.1 ml 5.00 (Jo-1 ab control) CA antibodies against smooth muscles IgG 0.1 ml 5.00 (ASMA control) CA antibodies against actin IgG 0.1 ml

65 Controls for EUROIMMUN IIFT: Systemic Autoantibodies Control (Ready for Use) Ig Class Format CA A antibodies against endomysium IgA 0.1 ml 5.00 (endomysium IgA control) CA A antibodies against endomysium plus gliadin IgA 0.1 ml 5.00 (endomysium plus gliadin IgA control) CA G antibodies against elastin IgG 0.1 ml 5.00 (elastin ab control) CA G antibodies against vascular endothelium IgG 0.1 ml 5.00 (vascular endothelium ab control) Further control sera for the determination of autoantibodies available upon request. Controls for the Determination of Autoantibodies 65

66 Controls for EUROIMMUN IIFT: Infectious Serology Control (Ready for Use) Ig Class Format CI A antibodies against Bordetella pertussis IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Bordetella pertussis IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Bordetella pertussis IgM 0.1 ml 5.00 IgM positive control CI Z Bordetella pertussis/parapertussis IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against Bordetella parapertussis IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Bordetella parapertussis IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Bordetella parapertussis IgM 0.1 ml 5.00 IgM positive control CI G * antibodies against Haemophilus influenzae IgG 0.1 ml 5.00 IgG positive control CI Z * Haemophilus influenzae IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against Helicobacter pylori IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Helicobacter pylori IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Helicobacter pylori IgM 0.1 ml 5.00 IgM positive control CI Z Helicobacter pylori IgA, IgG, IgM 0.1 ml 5.00 negative control Controls for Infectious Serology CI G * antibodies against Campylobacter jejuni IgG 0.1 ml 5.00 IgG positive control CI Z * Campylobacter jejuni/coli IgA, IgG, IgM 0.1 ml 5.00 negative control CI G * antibodies against Campylobacter coli IgG 0.1 ml 5.00 IgG positive control CI G * antibodies against Klebsiella pneumoniae IgG 0.1 ml 5.00 IgG positive control CI Z * Klebsiella pneumoniae IgA, IgG, IgM 0.1 ml 5.00 negative control CI G antibodies against Treponema pallidum IgG 0.1 ml 5.00 FTA IgG positive control CI M antibodies against Treponema pallidum IgM 0.1 ml 5.00 FTA IgM positive control CI Z Treponema pallidum IgA, IgG, IgM 0.1 ml 5.00 FTA negative control CI G antibodies against Treponema pallidum IgG 50 µl serum concentrate 5.00 IgG positive control for FTA absorption CI G antibodies against Reiter spirochetes IgG 0.1 ml 5.00 unspecific FTA IgG positive control CI G antibodies against Borrelia afzelii/b. burgdorferi/b. garinii IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Borrelia afzelii/b. burgdorferi/b. garinii IgM 0.1 ml 5.00 IgM positive control CI Z Borrelia afzelii/b. burgdorferi/b. garinii IgA, IgG, IgM 0.1 ml 5.00 negative control *) Currently not available as IVD in the European Union. 66

67 Controls for EUROIMMUN IIFT: Infectious Serology Control (Ready for Use) Ig Class Format CI 213a-0101 M antibodies against Borrelia (OspC antigen) IgM 0.1 ml 5.00 IgM positive control CI 213b-0101 G antibodies against Borrelia (VlsE antigen) IgG 0.1 ml 5.00 IgG positive control CI Z * Listeria monocytogenes IgA, IgG, IgM 0.1 ml 5.00 negative control CI G * antibodies against Listeria monocytogenes 1/2a IgG 0.1 ml 5.00 IgG positive control CI G * antibodies against Listeria monocytogenes 4b IgG 0.1 ml 5.00 IgG positive control CI P antibodies against Legionella pneumophila serotypes 1 or 4 IgM 0.1 ml 5.00 positive control CI G * antibodies against Legionella pneumophila serotype 1 IgG 0.1 ml 5.00 IgG positive control CI Z Legionella pneumophila/non-pneumophila IgA, IgG, IgM 0.1 ml 5.00 negative control CI 215b-0101 P antibodies against Legionella pneumophila mixture IgM 0.1 ml 5.00 IgM positive control CI 215d-0101 P antibodies against Legionella pneumophila mixture IgM 0.1 ml 5.00 IgM positive control CI 215f-0101 P antibodies against Legionella pneumophila mixture IgM 0.1 ml 5.00 IgM positive control CI 215h-0101 P antibodies against Legionella pneumophila mixture IgM 0.1 ml 5.00 IgM positive control CI G * antibodies against Yersinia enterocolitica IgG 0.1 ml 5.00 IgG positive control (for diagnosing various forms of arthritis) CI Z * Yersinia enterocolitica IgA, IgG, IgM 0.1 ml 5.00 negative control (for diagnosing various forms of arthritis) CI A antibodies against Chlamydia trachomatis IgA 0.1 ml 5.00 IgA positive control Controls for Infectious Serology CI G antibodies against Chlamydia trachomatis IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Chlamydia trachomatis IgM 0.1 ml 5.00 IgM positive control CI Z Chlamydia IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against Chlamydia pneumoniae IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Chlamydia pneumoniae IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Chlamydia pneumoniae IgM 0.1 ml 5.00 IgM positive control CI 219a-0101 G * antibodies against Afipia felis IgG 0.1 ml 5.00 IgG positive control CI 219a-0101 Z * Afipia felis IgA, IgG, IgM 0.1 ml 5.00 negative control CI 219b-0101 G antibodies against Bartonella henselae IgG 0.1 ml 5.00 IgG positive control CI 219b-0101 M antibodies against Bartonella henselae IgM 0.1 ml 5.00 IgM positive control *) Currently not available as IVD in the European Union. 67

68 Controls for EUROIMMUN IIFT: Infectious Serology Control (Ready for Use) Ig Class Format CI 219b-0101 Z Bartonella henselae/quintana IgA, IgG, IgM 0.1 ml 5.00 negative control CI 219d-0101 G antibodies against Bartonella quintana IgG 0.1 ml 5.00 IgG positive control CI 219d-0101 M antibodies against Bartonella quintana IgM 0.1 ml 5.00 IgM positive control CI G antibodies against Mycoplasma hominis IgG 0.1 ml 5.00 IgG positive control CI Z Mycoplasma hominis/pneumoniae and IgA, IgG, IgM 0.1 ml 5.00 Ureaplasma urealyticum negative control CI G antibodies against Mycoplasma pneumoniae IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Mycoplasma pneumoniae IgM 0.1 ml 5.00 IgM positive control CI G antibodies against Ureaplasma urealyticum IgG 0.1 ml 5.00 IgG positive control CI A antibodies against Leishmania donovani IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Leishmania donovani IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Leishmania donovani IgM 0.1 ml 5.00 IgM positive control CI Z Leishmania donovani IgA, IgG, IgM 0.1 ml 5.00 negative control CI G antibodies against Plasmodia IgG 0.1 ml 5.00 IgG positive control Controls for Infectious Serology CI Z Plasmodia IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against Echinococcus granulosus IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Echinococcus granulosus IgG 0.1 ml 5.00 IgG positive control CI Z Echinococcus granulosus IgA, IgG, IgM 0.1 ml 5.00 negative control CI A * antibodies against Toxoplasma gondii IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Toxoplasma gondii IgG 0.1 ml 5.00 IgG positive control CI H high-avid antibodies against Toxoplasma gondii IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Toxoplasma gondii IgM 0.1 ml 5.00 IgM positive control CI X low-avid antibodies against Toxoplasma gondii IgG 0.1 ml 5.00 IgG positive control CI Z Toxoplasma gondii IgA, IgG, IgM 0.1 ml 5.00 negative control CI G * antibodies against HIV-1 IgG 0.1 ml 5.00 IgG positive control CI Z * HIV-1/2 IgA, IgG, IgM 0.1 ml 5.00 negative control CI G * antibodies against HIV-2 IgG 0.1 ml 5.00 IgG positive control *) Currently not available as IVD in the European Union. 68

69 Controls for EUROIMMUN IIFT: Infectious Serology Control (Ready for Use) Ig Class Format CI G antibodies against Herpes simplex virus 1 (HSV-1) IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Herpes simplex virus 1 (HSV-1) IgM 0.1 ml 5.00 IgM positive control CI Z HSV-1/HSV-2 IgA, IgG, IgM 0.1 ml 5.00 negative control CI G antibodies against Herpes simplex virus 2 (HSV-2) IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Herpes simplex virus 2 (HSV-2) IgM 0.1 ml 5.00 IgM positive control CI G antibodies against human herpes virus 6 (HHV-6) IgG 0.1 ml 5.00 IgG positive control CI Z human herpes virus 6 (HHV-6) IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against Cytomegalovirus (CMV) IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Cytomegalovirus (CMV) IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Cytomegalovirus (CMV) IgM 0.1 ml 5.00 IgM positive control CI Z Cytomegalovirus (CMV) IgA, IgG, IgM 0.1 ml 5.00 negative control CI G antibodies against Rubella virus IgG 0.1 ml 5.00 IgG positive control CI H high-avid antibodies against Rubella virus IgG 0.1 ml 5.00 IgG positive control CI X low-avid antibodies against Rubella virus IgG 0.1 ml 5.00 IgG positive control CI Z Rubella virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against SARS coronavirus IgA 0.1 ml 5.00 IgA positive control CI G antibodies against SARS coronavirus IgG 0.1 ml 5.00 IgG positive control Controls for Infectious Serology CI M antibodies against SARS coronavirus IgM 0.1 ml 5.00 IgM positive control CI Z SARS coronavirus IgA, IgG, IgM 0.1 ml 5.00 negative control CI G antibodies against Measles virus IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Measles virus IgM 0.1 ml 5.00 IgM positive control CI Z Measles virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI G antibodies against Mumps virus IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Mumps virus IgM 0.1 ml 5.00 IgM positive control CI Z Mumps virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against Varicella zoster virus (VZV) IgA 0.1 ml 5.00 IgA positive control 69

70 Controls for EUROIMMUN IIFT: Infectious Serology Control (Ready for Use) Ig Class Format CI G antibodies against Varicella zoster virus (VZV) IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Varicella zoster virus (VZV) IgM 0.1 ml 5.00 IgM positive control CI Z Varicella zoster virus (VZV) IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against TBE virus IgA 0.1 ml 5.00 IgA positive control CI G antibodies against TBE virus IgG 0.1 ml 5.00 IgG positive control CI M antibodies against TBE virus IgM 0.1 ml 5.00 IgM positive control CI Z TBE virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI G antibodies against West-Nile virus IgG 0.1 ml 5.00 IgG positive control CI H high-avid antibodies against West-Nile virus IgG 0.1 ml 5.00 IgG positive control CI M antibodies against West-Nile virus IgM 0.1 ml 5.00 IgM positive control CI X low-avid antibodies against West-Nile virus IgG 0.1 ml 5.00 IgG positive control CI Z West-Nile virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI G * antibodies against Japanese encephalitis virus IgG 0.1 ml 5.00 IgG positive control Controls for Infectious Serology CI M * antibodies against Japanese encephalitis virus IgM 0.1 ml 5.00 IgM positive control CI Z * antibodies against Japanese encephalitis virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI G antibodies against Yellow fever virus IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Yellow fever virus IgM 0.1 ml 5.00 IgM positive control CI Z Yellow fever virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI 266a-0101 G antibodies against Dengue virus IgG 0.1 ml 5.00 IgG positive control CI 266a-0101 M antibodies against Dengue virus IgM 0.1 ml 5.00 IgM positive control CI 266a-0101 Z Dengue virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against Respiratory syncytial virus (RSV) IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Respiratory syncytial virus (RSV) IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Respiratory syncytial virus (RSV) IgM 0.1 ml 5.00 IgM positive control CI Z Respiratory syncytial virus (RSV) IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against Adenovirus IgA 0.1 ml 5.00 IgA positive control *) Currently not available as IVD in the European Union. 70

71 Controls for EUROIMMUN IIFT: Infectious Serology Control (Ready for Use) Ig Class Format CI G antibodies against Adenovirus IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Adenovirus IgM 0.1 ml 5.00 IgM positive control CI Z Adenovirus IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against Influenza virus type A IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Influenza virus type A IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Influenza virus type A IgM 0.1 ml 5.00 IgM positive control CI Z Influenza virus type A/B IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against Influenza virus type B IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Influenza virus type B IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Influenza virus type B IgM 0.1 ml 5.00 IgM positive control CI A antibodies against Parainfluenza virus types 1-4 IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Parainfluenza virus types 1-4 IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Parainfluenza virus types 1-4 IgM 0.1 ml 5.00 IgM positive control CI Z Parainfluenza virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI G antibodies against Coxsackie virus IgG 0.1 ml 5.00 IgG positive control CI Z Coxsackie virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI 275a-0101 G antibodies against Echo virus IgG 0.1 ml 5.00 IgG positive control Controls for Infectious Serology CI 275a-0101 Z Echo virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI 277a G * antibodies against Sandfly fever virus IgG 0.1 ml 5.00 IgG positive control CI 277a Z * Sandfly fever virus IgA, IgG, IgM 0.1 ml 5.00 negative control CI 278h G antibodies against Hantavirus IgG 0.1 ml 5.00 IgG positive control CI 278h M antibodies against Hantavirus IgM 0.1 ml 5.00 IgM positive control CI 278h Z Hantavirus IgA, IgG, IgM 0.1 ml 5.00 negative control CI A antibodies against Epstein-Barr virus capsid antigen (EBV-CA) IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Epstein-Barr virus capsid antigen (EBV-CA) IgG 0.1 ml 5.00 IgG positive control CI H high-avid antibodies against Epstein-Barr virus capsid antigen (EBV-CA) IgG 0.1 ml 5.00 IgG positive control *) Currently not available as IVD in the European Union. 71

72 Controls for EUROIMMUN IIFT: Infectious Serology Control (Ready for Use) Ig Class Format CI M antibodies against Epstein-Barr virus capsid antigen (EBV-CA) IgM 0.1 ml 5.00 IgM positive control CI X low-avid antibodies against Epstein-Barr virus (EBV-CA) IgG 0.1 ml 5.00 IgG positive control CI Z Epstein-Barr virus (EBV) IgA, IgG, IgM 0.1 ml 5.00 negative control CI C antibodies against Epstein-Barr virus nuclear antigen (EBNA) IgG 0.1 ml 5.00 complement-binding, positive control CI A antibodies against Epstein-Barr virus early antigen (EBV-EA) IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Epstein-Barr virus early antigen (EBV-EA) IgG 0.1 ml 5.00 IgG positive control CI H high-avid antibodies against Epstein-Barr virus early antigen (EBV-EA) IgG 0.1 ml 5.00 IgG positive control CI X low-avid antibodies against Epstein-Barr virus early antigen (EBV-EA) IgG 0.1 ml 5.00 IgG positive control CI A antibodies against Candida albicans IgA 0.1 ml 5.00 IgA positive control CI G antibodies against Candida albicans IgG 0.1 ml 5.00 IgG positive control CI M antibodies against Candida albicans IgM 0.1 ml 5.00 IgM positive control CI Z Candida albicans IgA, IgG, IgM 0.1 ml 5.00 negative control CI 293a-0101 G antibodies against Chikungunya virus IgG 0.1 ml 5.00 IgG positive control Controls for Infectious Serology CI 293a-0101 M antibodies against Chikungunya virus IgM 0.1 ml 5.00 IgM positive control CI 293a-0101 Z Chikungunya virus IgA, IgG, IgM 0.1 ml 5.00 negative control Further control sera for infectious serology available upon request. Controls for EUROIMMUN IIFT: Determination of Further Antibodies Control (Ready for Use) Ig Class Format CV A antibodies against Saccharomyces cerevisiae IgA 0.1 ml 5.00 IgA positive control CV G antibodies against Saccharomyces cerevisiae IgG 0.1 ml 5.00 IgG positive control CV M antibodies against Saccharomyces cerevisiae IgM 0.1 ml 5.00 IgM positive control CV Z Saccharomyces cerevisiae IgA, IgG, IgM 0.1 ml 5.00 negative control CV A antibodies against gliadin IgA 0.1 ml 5.00 (gliadin IgA control) CV G antibodies against gliadin IgG 0.1 ml 5.00 (gliadin IgG control) 72

73 Controls for EUROIMMUN Westernblots/EUROLINE-WB Control (50-fold concentrate) Ig Class Format CW A antibodies against Helicobacter pylori IgA 0.1 ml 8.00 IgA positive control CW G antibodies against Helicobacter pylori IgG 0.1 ml 8.00 IgG positive control CW ZA antibodies against Helicobacter pylori IgA 0.1 ml 8.00 IgA negative control CW ZG antibodies against Helicobacter pylori IgG 0.1 ml 8.00 IgG negative control CW YM antibodies against Treponema pallidum IgM 0.1 ml 8.00 IgM weakly reactive control CW G antibodies against Borrelia afzelii IgG 0.1 ml 8.00 IgG positive control (Westernblot/EUROLINE-WB) CW M antibodies against Borrelia afzelii IgM 0.1 ml 8.00 IgM positive control (Westernblot/EUROLINE-WB) CW YM antibodies against Borrelia afzelii IgM 0.1 ml 8.00 IgM weakly reactive control (Westernblot/EUROLINE-WB) CW ZG antibodies against Borrelia afzelii IgG 0.1 ml 8.00 IgG negative control (Westernblot/EUROLINE-WB) CW ZM antibodies against Borrelia afzelii IgM 0.1 ml 8.00 IgM negative control (Westernblot/EUROLINE-WB) CW G antibodies against Borrelia afzelii IgG 0.1 ml 8.00 IgG positive control 2 (Westernblot/EUROLINE-WB) CW G antibodies against Borrelia burgdorferi IgG 0.1 ml 8.00 IgG positive control CW M antibodies against Borrelia burgdorferi IgM 0.1 ml 8.00 IgM positive control CW YM antibodies against Borrelia burgdorferi IgM 0.1 ml 8.00 IgM weakly reactive control CW ZG antibodies against Borrelia burgdorferi IgG 0.1 ml 8.00 IgG negative control Controls for Infectious Serology CW ZM antibodies against Borrelia burgdorferi IgM 0.1 ml 8.00 IgM negative control CW G antibodies against Borrelia garinii IgG 0.1 ml 8.00 IgG positive control CW M antibodies against Borrelia garinii IgM 0.1 ml 8.00 IgM positive control CW YM antibodies against Borrelia garinii IgM 0.1 ml 8.00 IgM weakly reactive control CW ZG antibodies against Borrelia garinii IgG 0.1 ml 8.00 IgG negative control CW ZM antibodies against Borrelia garinii IgM 0.1 ml 8.00 IgM negative control CW A antibodies against Yersinia enterocolitica IgA 0.1 ml 8.00 IgA positive control (for diagnosing various forms of arthritis) CW G antibodies against Yersinia enterocolitica IgG 0.1 ml 8.00 IgG positive control (for diagnosing various forms of arthritis) 73

74 Controls for EUROIMMUN Westernblots/EUROLINE-WB Control (50-fold concentrate) Ig Class Format CW YA antibodies against Yersinia enterocolitica IgA 0.1 ml 8.00 IgA weakly reactive control (for diagnosing various forms of arthritis) CW ZA antibodies against Yersinia enterocolitica IgA 0.1 ml 8.00 IgA negative control (for diagnosing various forms of arthritis) CW ZG antibodies against Yersinia enterocolitica IgG 0.1 ml 8.00 IgG negative control (for diagnosing various forms of arthritis) CW G antibodies against Herpes simplex virus (HSV) IgG 0.1 ml 8.00 IgG positive control CW ZG antibodies against Herpes simplex virus (HSV) IgG 0.1 ml 8.00 IgG negative control CW ZM antibodies against Herpes simplex virus (HSV) IgM 0.1 ml 8.00 IgM negative control CW G antibodies against Epstein-Barr virus (EBV) IgG 0.1 ml 8.00 IgG positive control Controls for Infectious Serology 74

75 EUROASSAY for the Determination of Autoantibodies (Test Systems) Antibodies Ig Class Substrate Format against Slides x Fields per Field per Kit DA G thyroid peroxidase (TPO) IgG EUROASSAY strip 10 x DA G thyroglobulin (TG) with antigens 10 x DA G myeloperoxidase (MPO) IgG EUROASSAY strip 10 x DA G proteinase 3 (PR3) with antigens 10 x DA G AMA M2, LKM-1, SLA/LP IgG EUROASSAY strip 10 x with antigens DA G LKM-1, LC-1, SLA/LP IgG EUROASSAY strip 10 x DA G with antigens 10 x DA G Liver Profile IgG EUROASSAY strip 10 x AMA M2, LKM-1, LC-1, SLA/LP with antigens DA G Anti-ENA ProfilePlus IgG EUROASSAY strip 10 x DA G (nrnp/sm, Sm, SS-A, SS-B, Scl-70, with antigens 10 x Jo-1 separately) DA G Anti-ENA ProfilePlus with AMA M2 IgG EUROASSAY strip 10 x (nrnp/sm, Sm, SS-A, SS-B, Scl-70, with antigens Jo-1, AMA M2 separately) DA G SLE Profile IgG EUROASSAY strip 10 x DA G (nrnp/sm, Sm, SS-A, SS-B, dsdna, with antigens 10 x histones, ribosomal P-proteins separately) DA G Anti-ENA ProfilePlus with dsdna IgG EUROASSAY strip 10 x DA G (nrnp/sm, Sm, dsdna, Jo-1, with antigens 10 x SS-A, SS-B, Scl-70 separately) DA G Anti ENA Profile IgG EUROASSAY strip 10 x DA G (nrnp/sm, Sm, SS-A, SS-B separately) with antigens 10 x DA G Anti-ENA ProfilePlus with centromere protein B IgG EUROASSAY strip 10 x DA G (nrnp/sm, Sm, SS-A, SS-B, Scl-70, with antigens 10 x Jo-1, centromere protein B separately) DA G Anti-ENA ProfilePlus with histones IgG EUROASSAY strip 10 x DA G (nrnp/sm, Sm, SS-A, SS-B, Scl-70, with antigens 10 x Jo-1, histones separately) DA G Anti-ENA ProfilePlus with PM-Scl IgG EUROASSAY strip 10 x DA G (nrnp/sm, Sm, SS-A, SS-B, Scl-70, with antigens 10 x Jo-1, PM-Scl separately) DA G SLE Profile 2 IgG EUROASSAY strip 10 x DA G (nrnp/sm, Sm, SS-A, SS-B, dsdna, with antigens 10 x histones, nucleosomes separately) DA G SLE Profile 3 IgG EUROASSAY strip 10 x DA G (dsdna, histones, nucleosomes, with antigens 10 x ribosomal P-proteins separately) EUROASSAY/EUROLINE Westernblot DA G Anti-ENA ProfilePlus with Ro-52 IgG EUROASSAY strip 10 x DA G (nrnp/sm, Sm, SS-A, SS-B, Scl-70, with antigens 10 x Jo-1, Ro-52 separately) DA G Scl-70, Jo-1, PM-Scl IgG EUROASSAY strip 10 x DA G with antigens 10 x DA G Anti-ENA ProfilePlus with ribosomal P-proteins IgG EUROASSAY strip 10 x DA G (nrnp/sm, Sm, SS-A, SS-B, Scl-70, with antigens 10 x Jo-1, ribosomal P-proteins separately) DA G Anti-ENA ProfilePlus with nucleosomes IgG EUROASSAY strip 10 x DA G (nrnp/sm, Sm, nucleosomes, Jo-1, with antigens 10 x SS-A, SS-B, Scl-70 separately) DA O AMA Profile IgGM EUROASSAY strip 10 x (AMA M2, M4, M9 separately) with antigens If requested the EUROASSAY can be manufactured individually, thus offering special antigen combinations, e.g. dsdna, histones, nucleosomes, PM-Scl, nrnp/sm, Sm, SS-A (60 kda), Ro-52, SS-B, Scl-70, Jo-1, ribosomal P-proteins, centromere protein B, AMA M2, M4, M9, SLA/LP, LC-1, LKM-1. Slides with only one field can be delivered as special format. 75

76 EUROASSAY for Allergology (Test Systems) Antibodies Ig Class Substrate Format against Slides x Fields per Field per Kit DE E * allergy profile inhalation IgE EUROASSAY strip 10 x DE E * (gx, t3, w6, d1, e1, e2, m2) with allergens 10 x DE E * allergy profile food IgE EUROASSAY strip 10 x DE E * (f1, f2, f3, f4, f13, f14, f17) with allergens 10 x EUROLINE for the Determination of Autoantibodies (Test Systems) Antibodies Ig Class Substrate Format against per Strip per Kit DL G Neuronal Antigens Profile IgG membrane strip with antigens 16 x (amphiphysin, CV2, PNMA2 (Ma-2), (EUROLINE) Ri, Yo, Hu separately) DL G Gangliosides Profile 1 IgG membrane strip with antigens 16 x (GM1, GD1b, GQ1b separately) (EUROLINE) DL M Gangliosides Profile 1 IgM membrane strip with antigens 16 x (GM1, GD1b, GQ1b separately) (EUROLINE) DL G Gangliosides Profile 2 IgG membrane strip with antigens 16 x (GM1, GM2, GM3, GD1a, GD1b, GT1b, GQ1b separately) (EUROLINE) DL M Gangliosides Profile 2 IgM membrane strip with antigens 16 x (GM1, GM2, GM3, GD1a, GD1b, GT1b, GQ1b separately) (EUROLINE) EUROASSAY/EUROLINE Westernblot DL G myeloperoxidase (MPO) IgG membrane strip with antigens 16 x proteinase 3 (PR3) (EUROLINE) DL G myeloperoxidase (MPO) IgG membrane strip with antigens 16 x proteinase 3 (PR3) (EUROLINE) glomerular basement membrane (GBM) DL G Liver Profile IgG membrane strip with antigens 16 x (AMA M2, LKM-1, LC-1, SLA/LP separately) (EUROLINE) DL G Profile Autoimmune Liver Diseases IgG membrane strip with antigens 16 x (AMA M2, 3E (BPO), Sp100, PML, gp210, (EUROLINE) LC-1, LKM-1, SLA/LP, Ro-52 separately) DL G Myositis Profile IgG membrane strip with antigens 16 x (Mi-2, Ku, PM-Scl, Jo-1, PL-7, (EUROLINE) PL-12, Ro-52 separately) DL G Anti-ENA ProfilePlus 1 IgG membrane strip with antigens 16 x (nrnp/sm, Sm, SS-A, Ro-52, SS-B, (EUROLINE) Scl-70, Jo-1 separately) DL G ANA Profile 3 IgG membrane strip with antigens 16 x (nrnp/sm, Sm, SS-A, Ro-52, SS-B, Scl-70, (EUROLINE) PM-Scl, Jo-1, centromere protein B, PCNA, dsdna, nucleosomes, histones, ribosomal P-proteins, AMA M2 separately) DL G ANA Profile 1 IgG membrane strip with antigens 16 x (nrnp/sm, Sm, SS-A, Ro-52, SS-B, Scl-70, (EUROLINE) Jo-1, centromere protein B, dsdna, nucleosomes, histones, ribosomal P-proteins separately) *) Currently not available as IVD in the European Union. 76

77 EUROLINE for Infectious Serology (Test Systems) Antibodies Ig Class Substrate Format against per Strip per Kit DN G Malaria Profile 1 IgG membrane strip with antigens 16 x (Plasmodium falciparum HRP-2 and MSP-2, (EUROLINE) Plasmodium vivax MSP and CSP separately) DN G * TO.R.C.H. Profile IgG membrane strip with antigens 16 x (Toxoplasma gondii, Rubella virus, (EUROLINE) CMV, HSV-1, HSV-2 separately) DN M * TO.R.C.H. Profile IgM membrane strip with antigens 16 x (Toxoplasma gondii, Rubella virus, (EUROLINE) CMV, HSV-1, HSV-2 separately) DN G EBV Profile 2 IgG membrane strip with antigens 16 x (VCA gp125, VCA p19, (EUROLINE) EBNA-1, p22, EA-D separately) DN M EBV Profile 2 IgM membrane strip with antigens 16 x (VCA gp125, VCA p19, (EUROLINE) EBNA-1, p22, EA-D separately) EUROLINE for Allergology (Test Systems) Antibodies Ig Class Substrate Format against per Strip per Kit DP E allergy profile inhalation IgE membrane strip with allergens 16 x (g1, g3, g6, g12, t2, t3, t4, t7, w1, w6, w9, (EUROLINE) d1, d2, e1, e2, e3, m1, m2, m3, m6) DP E allergy profile pediatric inhalation IgE membrane strip with allergens 16 x (g6, g12, t2, t3, t4, w6, w8, w9, d1, d2, (EUROLINE) e1, e2, e3, e6, e82, e84, m1, m2, m3, m6) DP E allergy profile Mediterranean inhalation IgE membrane strip with allergens 16 x (g2, g6, t3, t4, t9, t11, t23, t210, w1, w6, w9, w19, (EUROLINE) d1, d2, d70, e1, e2, e3, m2, m6) DP E allergy profile inhalation South East Asia IgE membrane strip with allergens 16 x (gs1, ts19, t104, t119, t223, ds1, i6, e1, e2, es172, e6, (EUROLINE) e71, e82, e84, ms1, ms4, m5, m12, m45, u134) DP E * allergy profile inhalation Korea 1 IgE membrane strip with allergens 16 x (g2, g3, g6, g12, ts3, ts11, ts14, ts15, t4, t7, t12, t19, t71, (EUROLINE) w100, f1, f2, f14, f23, f234, f95) DP E * allergy profile inhalation Korea 2 IgE membrane strip with allergens 16 x (w1, w6, w8, w11, w14, w12, m1, m2, m3, m6, e1, e2, (EUROLINE) i6, h1, d1, d2, g7, ts4, t1, t16) DP E * allergy profile inhalation China IgE membrane strip with allergens 16 x (gs23, ts21, t3, t8, t11, t12, t14, t70, ws18, w1, w6, (EUROLINE) w9, es1, d1, d2, i6, ms5, m1, u73, u80) EUROASSAY/EUROLINE Westernblot DP E * allergy profile inhalation Middle East IgE membrane strip with allergens 16 x (g1, g6,g12, t2, t3, t7, t9, w1, w6, w8, d1, d2, i6, e1, (EUROLINE) e84, m1, m2, m3, m5, m6) DP E * allergy profile inhalation Gulf IgE membrane strip with allergens 16 x (g6, g12, t2, t3, t7, t9, w1, w6, d1, d2, i6, (EUROLINE) e1, e2, e3, e17, m1, m2, m3, m5, m6) DP E allergy profile food IgE membrane strip with allergens 16 x (f1, f75, f2, f45, f4, f5, f9, f13, f14, f17, f20, (EUROLINE) f49, f84, f237, f25, f31, f35, f85, f3, f23) DP E allergy profile food South East Asia 1 IgE membrane strip with allergens 16 x (f1, f75, f2, f4, f9, f10, f14, f13, f17, f63, f64, f83, (EUROLINE) fs10, fs14, f23, f24, f80, f179, f105, f336) DP E * allergy profile food South East Asia 2 IgE membrane strip with allergens 16 x (f1, f75, f2, f4, f9, f10, f14, f13, f17, f63, f340, f83, fs10, (EUROLINE) fs14, f23, f24, f80, f179, f105, f336) DP E * allergy profile food Korea 1 IgE membrane strip with allergens 16 x (f1, f2, f14, f81, f3, f23, f40, f41, f234, f26, f27, f83, fs15, (EUROLINE) f95, f4, f6, f9, f292, f47, f48) *) Currently not available as IVD in the European Union. 77

78 EUROLINE for Allergology (Test Systems) Antibodies Ig Class Substrate Format against per Strip per Kit DP E * allergy profile food Korea 2 IgE membrane strip with allergens 16 x (f1, f2, f14, f81, f3, f23, f40, f41, f234, f26, f27, f83, fs15, (EUROLINE) f95, f4, f6, f9, f292, f47, f48) DP E * allergy profile food China IgE membrane strip with allergens 16 x (f1, f2, f4, f7, f27, f88, fs35, f13, f14, fs40, f25, f292, (EUROLINE) fs42, f23, f234, f3, f41, f56, fs41, fs77) DP E * allergy profile food Middle East IgE membrane strip with allergens 16 x (f1, f75, f2, f78, e204, f4, f14, f45, f13, f17, f20, f33, f49, (EUROLINE) f29, f25, f31, f85, f48, f89, f88) DP E * allergy profile food Gulf IgE membrane strip with allergens 16 x (f1, f75, f2, f105, f4, f14, f45, fs36, f13, f29, f33, (EUROLINE) f44, f93, f25, f31, f48, f83, f88, f3, f23) DP E * allergy profile food Cyprus 1 IgE membrane strip with allergens 16 x (f1, f2, f75, f76, f77, f78, f81, f4, f45, f5, f14, (EUROLINE) f7, f79, f9, f10, f13, f144, f17, f20, f49) DP E * allergy profile food Cyprus 2 IgE membrane strip with allergens 16 x (f177, f23, f234, f24, f258, f3, f37, f40, f41, f80, (EUROLINE) f48, f108, f132, f212, f25, f292, f31, f35, f47, f96) DP E * allergy profile food Cyprus 3 IgE membrane strip with allergens 16 x (f26, f63, f83, f88, f237, f29, f32, f328, f33, f44, f49, (EUROLINE) f72, f84, f95, f281, f86, f89, f90, f105, f93) DP E allergy profile atopy IgE membrane strip with allergens 16 x (g6, g12, t3, w6, d1, e1, e2, e3, m2, m6, f1, f2, (EUROLINE) f3, f4, f9, f14, f17, f31, f35, f49) DP E allergy profile pollen-food cross reactions IgE membrane strip with allergens 16 x (g6, t3, w6, f4, f5, f13, f17, f20, f48, f89, f271, f275, (EUROLINE) f44, f49, f348, f237, f328, f31, f35, f85) DP E allergy profile pediatrics IgE membrane strip with allergens 16 x (gx, t3, w6, d1, d2, e1, e2, e3, m2, m3, m6,f1, f2, f3, (EUROLINE) f4, f9, f13, f14, f17, f31, f35, f49, f75, f76, f77, f78) EUROASSAY/EUROLINE Westernblot DP E allergy profile atopy China IgE membrane strip with allergens 16 x (ts20, w1, w6, ds1, h1, e1, e2, i6, ms1, u80, f1, f2, f13, (EUROLINE) f14, f27, f88, fs33, fs34, f23, f234) DP E allergy profile atopy China 2 IgE membrane strip with allergens 16 x (w18, w6, u80, ds1, es1, ms5, f245, (EUROLINE) fs56, fs43, fs42, fs34) DP E * allergy profile atopy China 3 IgE membrane strip with allergens 16 x (ts22, w6, us1, ds1, es1, h1, ms5, f245, fs9, fs43, (EUROLINE) fs56, fs34, fs44) DP E allergy profile insect venoms IgE membrane strip with allergens 16 x (i1, i3) (EUROLINE) Westernblot/EUROLINE-WB for the Determination of Autoantibodies (Test Systems) Antibodies Antigen and Ig Class Format against Antigen Source per Strip per Kit DW G EUROLINE-WB whole antigen, SDS extract IgG 16 x DW G neuronal antigens (Hu, Yo, Ri) of primate cerebellum 24 x plus recombinant Hu, Yo and Ri plus recombinant Hu, Yo and Ri DW G EUROLINE-WB whole antigen, SDS extract IgG 16 x DW G HEp-2 cell antigens of HEp-2 cells plus native SS-A 30 x (nucleolar, cytoplasmic, mitochondrial) and recombinant CENP B and Ro-52 plus CENP B, SS-A and Ro-52 DW G EUROLINE-WB whole antigen, SDS extract of IgG 16 x Myositis HeLa cells plus recombinant (Mi-2, Ku plus recombinant PM-Scl, PM-Scl, PL-7, PL-12 and native Jo-1 PL-7, PL-12 and native Jo-1) *) Currently not available as IVD in the European Union. 78

79 Westernblot/EUROLINE-WB for Infectious Serology (Test Systems) Antibodies Antigen and Ig Class Format against Antigen Source per Strip per Kit DY A Helicobacter pylori whole antigen, IgA 16 x DY A SDS extract 30 x DY G Helicobacter pylori whole antigen, IgG 16 x DY G SDS extract 30 x DY G Treponema pallidum 15 kda, 17 kda, IgG 16 x DY G 45 kda (tmpa), 47 kda 24 x DY M Treponema pallidum 15 kda, 17 kda, IgM 16 x DY M 45 kda (tmpa), 47 kda 24 x DY G EUROLINE-WB 15 kda, 17 kda, 45 kda (tmpa) 47 kda, IgG 16 x DY G Treponema pallidum plus purified cardiolipin 24 x plus cardiolipin DY M EUROLINE-WB 15 kda, 17 kda, 45 kda (tmpa) 47 kda, IgM 16 x DY M Treponema pallidum plus purified cardiolipin 24 x plus cardiolipin DY G Borrelia afzelii whole antigen, SDS extract of IgG 16 x DY G Borrelia afzelii 30 x DY G 32 x DY G 240 x , DY M Borrelia afzelii whole antigen, SDS extract of IgM 16 x DY M Borrelia afzelii 30 x DY M 32 x DY M 240 x , DY G EUROLINE-WB whole antigen, SDS extract of IgG 16 x DY G Borrelia Borrelia afzelii plus VlsE 30 x DY G 240 x , DY M EUROLINE-WB whole antigen, SDS extract of IgM 16 x DY M Borrelia Borrelia afzelii plus VlsE 30 x DY M 240 x , DY G Borrelia burgdorferi whole antigen, SDS extract of IgG 16 x DY G Borrelia burgdorferi sensu stricto 30 x DY G 32 x DY G 240 x , DY M Borrelia burgdorferi whole antigen, SDS extract of IgM 16 x DY M Borrelia burgdorferi sensu stricto 30 x DY M 32 x DY M 240 x , DY G Borrelia garinii whole antigen, SDS extract IgG 16 x DY G of Borrelia garinii 30 x DY G 32 x DY G 240 x , DY M Borrelia garinii whole antigen, SDS extract of IgM 16 x DY M Borrelia garinii 30 x DY M 32 x DY M 240 x , EUROASSAY/EUROLINE Westernblot DY A Yersinia enterocolitica isolated virulence factors IgA 16 x DY A Detection of antibodies against virulence factors of the (release proteins, Yop) 30 x Yersinia enterocolitica pathogen in human serum of Yersinia enterocolitica (for diagnosing various forms of arthritis). DY G Yersinia enterocolitica isolated virulence factors IgG 16 x DY G Detection of antibodies against virulence factors of the (release proteins, Yop) 30 x Yersinia enterocolitica pathogen in human serum of Yersinia enterocolitica (for diagnosing various forms of arthritis). DY G Echinococcus granulosus whole antigen, IgG 16 x DY G SDS extract 24 x

80 Westernblot/EUROLINE-WB for Infectious Serology (Test Systems) Antibodies Antigen and Ig Class Format against Antigen Source per Strip per Kit DY G EUROLINE-WB whole antigen, SDS extract of the IgG 16 x DY G Herpes simplex virus 1 (HSV-1) HSV-1 strain McIntire plus gg2 24 x plus HSV-2 type-specific purified by affinity chromatography glycoprotein G2 DY M EUROLINE-WB whole antigen, SDS extract of the IgM 16 x DY M Herpes simplex virus 1 (HSV-1) HSV-1 strain McIntire plus gg2 24 x plus HSV-2 type-specific purified by affinity chromatography glycoprotein G2 DY G * Cytomegalovirus whole antigen, IgG 16 x DY G * (CMV) SDS extract 24 x DY M * Cytomegalovirus whole antigen, IgM 16 x DY M * (CMV) SDS extract 24 x DY G Epstein-Barr virus whole antigen, IgG 16 x DY G (EBV) SDS extract 24 x DY M Epstein-Barr virus whole antigen, IgM 16 x DY M (EBV) SDS extract 24 x EUROASSAY/EUROLINE Westernblot *) Currently not available as IVD in the European Union. 80

81 Microplate ELISA for the Determination of Autoantibodies (Test Systems) Antibodies Antigen and Ig Class Calibration Format against Antigen Source per Well per Kit EA G thyroid peroxidase recombinant, expression with IgG 10/50/500 IU/ml 96 x (TPO) Baculovirus vector in insect cells EA G thyroglobulin native, human IgG 20/100/1000 IU/ml 96 x (TG) thyroid gland EA G TSH receptor native, IgG 0/1/2/8/40 IU/l 96 x (thyrotropin receptor) porcine thyrocytes EA G TSH receptor native, IgG 0.1/1/2/8/40 IE/l 96 x (thyrotropin receptor) porcine thyrocytes Fast ELISA EA G GAD recombinant IgG 5/15/35/120/ 96 x glutamic acid decarboxylase 250/2000 IU/ml EA G GAD/IA2 Pool recombinant IgG 4/10/20/70/ 96 x glutamic acid decarboxylase/ 145/450 IU/ml tyrosine phosphatase EA G IA2 recombinant IgG 15/60/200/400/ 96 x tyrosine phosphatase 4000 IU/ml EA G ANCA Profile (proteinase 3, MPO, elastase, native, human IgG semi-quantitative 12 x cathepsin G, BPI, lactoferrin separately) neutrophil granulocytes EA G canca: native, human IgG 2/20/200 RU/ml 96 x proteinase 3 neutrophil granulocytes EA G canca: native, human IgG 2/20/200 RU/ml 96 x proteinase 3 neutrophil granulocytes (capture test) EA G canca: native, human IgG 2/20/200 RU/ml 96 x proteinase 3 neutrophil granulocytes (PR3-hn-hr) recombinant, human c-dna expressed in human cell line EA G panca: native, human IgG 2/20/200 RU/ml 96 x myeloperoxidase (MPO) neutrophil granulocytes EA G glomerular basement membrane alpha-3-chain of type IV collagen, IgG 2/20/200 RU/ml 96 x (GBM) incl. NC1 domain, from bovine kidney EA G soluble liver antigen/ recombinant SLA/LP IgG 2/20/200 RU/ml 96 x liver-pancreas antigen (SLA/LP) expression in E. coli EA G cytosolic recombinant formiminotransferase- IgG semi-quantitative 96 x liver antigen type 1 cyclodeaminase, expression with (LC-1) baculovirus vector in insect cells EA G liver-kidney microsomes recombinant cytochrome P450 IID6, IgG 2/20/200 RU/ml 96 x LKM-1 expression with baculovirus vector in insect cells EA G parietal cells native, H+/K+ ATPase, IgG 2/20/200 RU/ml 96 x (PCA) porcine gastric mucosa EA G intrinsic factor native, porcine IgG 2/20/200 RU/ml 96 x gastric mucosa Microplate ELISA for the Determination of Autoantibodies EA G BP180-4X recombinant, expression in E. coli, IgG 2/20/200 RU/ml 48 x tetramer of the NC16A domain EA G cyclic citrullinated peptides highly purified synthetic IgG 1/5/20/100/200 RU/ml 96 x (CCP) CCP (second generation) EA G histones native, mixture of individually isolated IgG 2/20/200 RU/ml 96 x histone types H1/H2a/H2b/H3/H4, bovine EA G double-stranded DNA highly purified genomic IgG 10/100/800 IU/ml 96 x (dsdna) double-stranded DNA EA G dsdna-ncx highly purified genomic IgG 10/100/800 IU/ml 96 x double-stranded DNA, complexed with nucleosomes EA G C1q native, IgG 2/20/200 RU/ml 96 x human C1q 81

82 Microplate ELISA for the Determination of Autoantibodies (Test Systems) Antibodies Antigen and Ig Class Calibration Format against Antigen Source per Well per Kit EA G nucleosomes native, nucleosomes, IgG 2/20/200 RU/ml 96 x calf thymus EA G single-stranded DNA heat-denatured ssdna IgG 2/20/200 RU/ml 96 x (ssdna) EA G PM-Scl recombinant, IgG 2/20/200 RU/ml 96 x expression in E. coli EA G Anti-ENA ProfilePlus 1 (nrnp/sm, see individual ELISA IgG semi-quantitative 12 x Sm, SS-A, SS-B, Scl-70, Jo-1 separately) EA G Anti-ENA ProfilePlus 2 (ribosomal see individual ELISA IgG semi-quantitative 12 x P-proteins, nrnp/sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromere, separately) EA G Anti-ENA SLE Profile 1 (dsdna, histones, see individual ELISA IgG semi-quantitative 12 x ribosomal P-proteins, nrnp/sm, Sm, SS-A, SS-B, Scl-70 separately) EA G Anti-ENA PoolPlus (antigen mixture: see individual ELISA IgG semi-quantitative 96 x nrnp/sm, Sm, SS-A, SS-B, Scl-70, Jo-1) EA G ANA screen (antigen mixture: dsdna, see individual ELISA IgG semi-quantitative 96 x histones, ribosomal P-proteins, nrnp/sm, Sm, SS-A, SS-B, Scl-70, Jo-1, centromere) EA G * Anti-ENA Pool (antigen mixture: see individual ELISA IgG semi-quantitative 96 x nrnp/sm, Sm, SS-A, SS-B, Scl-70, ribosomal P-proteins, Ro-52) EA G ANA VarioProfile (optionally histones, see individual ELISA IgG semi-quantitative 96 x dsdna, nucleosomes, ssdna, PM-Scl, nrnp/sm, Sm, SS-A, SS-B, Scl-70, ribosomal P-proteins, Jo-1, AMA M2, centromere) maximum 4 different microplate strips EA G *ANA screen 11 (antigen mixture: PCNA, PM-Scl,see individual ELISA IgG semi-quantitative 96 x ribosomal P-proteins, nrnp/sm, Sm, SS-A, Ro-52, SS-B, Scl-70, Jo-1, centromere) Microplate ELISA for the Determination of Autoantibodies EA G Anti-ENA SLE Profile 2 (dsdna, histones, see individual ELISA IgG semi-quantitative 12 x nucleosomes, nrnp/sm, Sm, SS-A, SS-B, Scl-70 separately) EA G *ANA screen 9 (antigen mixture: PCNA, PM-Scl,see individual ELISA IgG semi-quantitative 96 x ribosomal P-proteins, nrnp/sm, Sm, SS-A, SS-B, Scl-70, Jo-1) EA G nrnp/sm native, U1-nRNP, incl. 70K, A, C, B, B, IgG 2/20/200 RU/ml 96 x D, E, F, G, calf thymus EA G Sm native, U2, U4, U5, U6-nRNP, incl. B, B, IgG 2/20/200 RU/ml 96 x D, E, F, G, bovine thymus EA G SS-A (Ro) native, SS-A-specific proteins (60 kda), IgG 2/20/200 RU/ml 96 x bovine spleen and thymus EA G SS-B (La) native, SS-B-specific protein (48 kda), IgG 2/20/200 RU/ml 96 x calf and rabbit thymus EA G Scl-70 native, DNA topoisomerase I, IgG 2/20/200 RU/ml 96 x calf thymus EA G centromeres recombinant centromere protein B, IgG 2/20/200 RU/ml 96 x expression with baculovirus vector in insect cells EA A cardiolipin (AMA M1) native, IgA 2/12/120 PL IgA U/ml 96 x bovine heart EA G cardiolipin (AMA M1) native, IgG 2/12/120 PL IgG U/ml 96 x bovine heart EA M cardiolipin (AMA M1) native, IgM 2/12/120 PL IgM U/ml 96 x bovine heart *) Currently not available as IVD in the European Union. 82

83 Microplate ELISA for the Determination of Autoantibodies (Test Systems) Antibodies Antigen and Ig Class Calibration Format against Antigen Source per Well per Kit EA P cardiolipin (AMA M1) native, IgM 2/12/120 RU/ml 96 x bovine heart EA 162a-9601 A phosphatidylserine native, IgA 2/12/120 RU/ml 96 x bovine brain EA 162a-9601 G phosphatidylserine native, IgG 2/12/120 RU/ml 96 x bovine brain EA 162a-9601 M phosphatidylserine native, IgM 2/12/120 RU/ml 96 x bovine brain EA 162a-9601 P phosphatidylserine native, IgM 2/12/120 RU/ml 96 x bovine brain EA G AMA M2-3E native, pyruvate dehydrogenase IgG 2/20/200 RU/ml 96 x complex, porcine heart plus recombinant M2 fusion antigen (BPO) EA A ß2-glycoprotein 1 native, IgA 2/20/200 RU/ml 96 x human serum EA G ß2-glycoprotein 1 native, IgG 2/20/200 RU/ml 96 x human serum EA M ß2-glycoprotein 1 native, IgM 2/20/200 RU/ml 96 x human serum EA P ß2-glycoprotein 1 native, IgM 2/20/200 RU/ml 96 x human serum EA G ribosomal P-proteins native, P0/P1/P2 of the 60S ribosomal IgG 2/20/200 RU/ml 96 x subunit, bovine and rabbit thymus EA G Jo-1 native, histidyl-trna synthetase, IgG 2/20/200 RU/ml 96 x calf thymus EA A IgA rheumatoid factor IgG, IgA 2/20/200 RU/ml 96 x (ab of class IgA against IgG) human EA G IgG rheumatoid factor IgG, IgG 2/20/200 RU/ml 96 x (ab of class IgG against IgG) goat EA M IgM rheumatoid factor IgG, IgM 2/20/200 RU/ml 96 x (ab of class IgM against IgG) human EA G circulating immune complexes native, IgG 2/20/200 RU/ml 96 x (CIC) human C1q EA A tissue transglutaminase recombinant, IgA 2/20/200 RU/ml 96 x (endomysium) expression with baculovirus vector in insect cells EA G tissue transglutaminase recombinant, IgG semi-quantitative 96 x (endomysium) expression with baculovirus vector in insect cells EA N * tissue transglutaminase recombinant, Ig 2/20/200 RU/ml 96 x (endomysium) expression with baculovirus vector in insect cells Microplate ELISA for the Determination of Autoantibodies *) Currently not available as IVD in the European Union. 83

84 Radioimmunoassays (RIA) for the Determination of Autoantibodies (Test Systems) Antibodies Antigen and Calibration Format against Antigen Source per Well per Kit RA thyroid peroxidase (TPO) native thyroid 0/8/40/200/1000/ 100 x coated tubes (CT) peroxidase, human 7500 U/ml RA thyroid peroxidase (TPO) native thyroid 12/40/120/400/ 100 x precipitation peroxidase, human 1200/4000 U/ml RA thyroid peroxidase (TPO) native thyroid 20/80/400/2000/ 100 x RA magnetic separation peroxidase, human 8000 U/ml 200 x RA thyroglobulin (TG) native thyroglobulin, 0/20/50/200/1000/ 100 x coated tubes (CT) human 4000 U/ml RA thyroglobulin (TG) native thyroglobulin, 6/20/60/200/600/ 100 x precipitation human 2000 U/ml RA thyroglobulin (TG) native thyroglobulin, 20/80/250/1000/ 100 x magnetic separation human 4000 U/ml RA TSH receptor native TSH receptor, 0/1/2/8/40 IU/l 100 x coated tubes (CT) porcine RA TSH receptor native TSH receptor, 0/5/15/45/135/405 U/l 100 x polyethyleneglycol (PEG) separation porcine RA GAD recombinant 0/1/3/10/30/300 U/ml 50 x RA precipitation glutamic acid decarboxylase 100 x RA IA2 recombinant 0/0.75/2/10/50 U/ml 50 x RA precipitation tyrosine phosphatase 100 x RA insulin synthetic product, 0/0.5/1/10/50 U/ml 50 x RA precipitation human 100 x RA acetylcholine receptor (ACHR) extract, 0/0.25/0.5/2/ 25 x RA precipitation human 4/8 nmol/l 100 x RA * P/Q calcium channels (VGCC) extract, indirect 12 x precipitation leporine RA double-stranded DNA (dsdna) plasmid DNA variable calibration 100 x precipitation Microplate ELISA for the Determination of Autoantibodies RIA for Direct Detection of Autoantigens, Hormone Determination (Test Systems) Antigen Analyte Calibration Format per Well RD thyroglobulin (TG) native 0.3/1/4/20/100/ 100 x coated tubes (CT); IRMA thyroglobulin 250 ng/ml per Kit RD free triiodothyronin (FT3) triiodothyronin, 0/2/5/10/20/ 100 x coated tubes (CT) human 40 pmol/l RD free thyroxin (FT4) thyroxin, 0/6/12/25/50/ 100 x coated tubes (CT) human 100 pmol/l RD thyrotropin (TSH) thyrotropin, 0/0.06/0.15/0.6/2.5/ 100 x coated tubes (CT); IRMA human 15/50/100 µlu/ml RD calcitonin calcitonin, 6 standards, variable 100 x coated tubes (CT); IRMA human pg/ml *) Currently not available as IVD in the European Union. 84

85 Microplate ELISA for Infectious Serology (Test Systems) Antibodies Antigen and Ig Class Calibration Format against Antigen Source per Well per Kit EI G diphtheria toxoid inactivated IgG 0.01/0.1/1/2 IU/ml 96 x diphtheria toxin EI G tetanus toxoid inactivated IgG 0,01/0,1/1/4/10 IU/ml 96 x tetanus toxin EI A Helicobacter pylori bacterial lysate, IgA semi-quantitative 96 x strain ATCC EI G Helicobacter pylori bacterial lysate, IgG 2/20/200 RU/ml 96 x strain ATCC EI A Helicobacter pylori recombinant CagA, IgA semi-quantitative 96 x (CagA) expression in E. coli EI G Helicobacter pylori recombinant CagA, IgG 2/20/200 RU/ml 96 x (CagA) expression in E. coli EI G Treponema pallidum 15 kda, 17 kda, 47 kda, IgG 2/20/200 RU/ml 96 x kda (TmpA) EI M Treponema pallidum 15 kda, 17 kda, 47 kda, IgM semi-quantitative 96 x incl. IgG/RF absorbent 42 kda (TmpA) EI O Treponema pallidum 15 kda, 17 kda, 47 kda, IgGM 2/20/200 RU/ml 96 x screen ELISA 42 kda (TmpA) EI L G Treponema pallidum 15 kda, 17 kda, 47 kda, IgG 5/25/50/100 U 96 x antibody determination in CSF 42 kda (TmpA) EI G Borrelia whole antigen, SDS extracts of IgG 2/20/200 RU/ml 96 x Borrelia burgdorferi sensu stricto, Borrelia garinii and Borrelia afzelii EI M Borrelia whole antigen, SDS extracts of IgM 2/20/200 RU/ml 96 x incl. IgG/RF absorbent Borrelia burgdorferi sensu stricto, Borrelia garinii and Borrelia afzelii EI G Borrelia burgdorferi recombinant VlsE from IgG 2/20/200 RU/ml 96 x VlsE Borrelia burgdorferi sensu stricto EI G Borrelia whole antigen, SDS extracts of IgG 2/20/200 RU/ml 96 x PLUS VlsE Borrelia burgdorferi sensu stricto, Borrelia garinii and Borrelia afzelii PLUS recombinant VlsE from Borrelia burgdorferi sensu stricto EI L G Borrelia PLUS VlsE whole antigen, SDS extracts of IgG 5/25/50/100 U 96 x antibody determination in CSF Borrelia burgdorferi sensu stricto, Borrelia garinii and Borrelia afzelii PLUS recombinant VlsE from Borrelia burgdorferi sensu stricto EI L M Borrelia whole antigen, SDS extracts of IgM 5/25/50/100 U 96 x antibody determination in CSF Borrelia burgdorferi sensu stricto, Borrelia garinii and Borrelia afzelii EI A Legionella pneumophila native, lipopolysaccharide (LPS) IgA semi-quantitative 96 x of the serotypes 1-7 Microplate ELISA for Infectious Serology EI G Legionella pneumophila native, lipopolysaccharide (LPS) IgG 2/20/200 RU/ml 96 x of the serotypes 1-7 EI M Legionella pneumophila native, lipopolysaccharide (LPS) IgM semi-quantitative 96 x incl. IgG/RF absorbent of the serotypes 1-7 EI A Yersinia enterocolitica recombinant Yop D IgA semi-quantitative 96 x Detection of antibodies against virulence of Yersinia factors of the Yersinia enterocolitica pathogen enterocolitica in human serum (for diagnosing various forms of arthritis) EI G Yersinia enterocolitica isolated virulence factors IgG 2/20/200 RU/ml 96 x Detection of antibodies against virulence (release proteins, Yop) factors of the Yersinia enterocolitica pathogen of Yersinia in human serum (for diagnosing various enterocolitica forms of arthritis) 85

86 Microplate ELISA for Infectious Serology (Test Systems) Antibodies Antigen and Ig Class Calibration Format against Antigen Source per Well per Kit EI A Brucella abortus bacterial lysate, IgA semi-quantitative 96 x Brucella abortus strain W99 EI G Brucella abortus bacterial lysate, IgG 2/20/200 RU/ml 96 x Brucella abortus strain W99 EI M Brucella abortus bacterial lysate, IgM semi-quantitative 96 x incl. IgG/RF absorbent Brucella abortus strain W99 EI A Chlamydia trachomatis native MOMP antigen, IgA semi-quantitative 96 x infected BGM cells, serotype K EI G Chlamydia trachomatis native MOMP antigen, IgG 2/20/200 RU/ml 96 x infected BGM cells, serotype K EI M Chlamydia trachomatis native MOMP antigen, IgM semi-quantitative 96 x incl. IgG/RF absorbent infected BGM cells, serotype K EI A Chlamydia pneumoniae cell lysate of HL cells, IgA semi-quantitative 96 x strain CDC/CWL-029 EI G Chlamydia pneumoniae cell lysate of HL cells, IgG 2/20/200 RU/ml 96 x strain CDC/CWL-029 EI M Chlamydia pneumoniae cell lysate of HL cells, IgM semi-quantitative 96 x incl. IgG/RF absorbent strain CDC/CWL-029 EI A Mycoplasma pneumoniae detergent extract of IgA semi-quantitative 96 x strain Mac ATCC EI G Mycoplasma pneumoniae detergent extract of IgG 2/20/200 RU/ml 96 x strain Mac ATCC EI M Mycoplasma pneumoniae detergent extract of IgM semi-quantitative 96 x incl. IgG/RF absorbent strain Mac ATCC EI G Echinococcus granulosus cyst extract IgG 2/20/200 RU/ml 96 x EI A * Toxoplasma gondii whole antigen, IgA semi-quantitative 96 x strain Deelen EI G Toxoplasma gondii whole antigen, IgG 1/10/200 IU/ml 96 x strain Deelen EI M Toxoplasma gondii whole antigen, IgM semi-quantitative 96 x incl. IgG/RF absorbent strain Deelen EI G Toxoplasma gondii whole antigen, IgG without calibration 96 x avidity determination strain Deelen Microplate ELISA for Infectious Serology EI L G Toxoplasma gondii whole antigen, IgG 5/25/50/100 U 96 x antibody determination in CSF strain Deelen EI A Herpes simplex virus HSV-1: strain Mac Intyre (ATCC VR-539) IgA semi-quantitative 96 x (HSV-1/2 Pool) HSV-2: strain MS (ATCC VR-540) EI G Herpes simplex virus HSV-1: strain Mac Intyre (ATCC VR-539) IgG 2/20/200 RU/ml 96 x (HSV-1/2 Pool) HSV-2: strain MS (ATCC VR-540) EI L G Herpes simplex virus HSV-1: strain Mac Intyre (ATCC VR-539) IgG 1/8/40/100 RU/ml 96 x (HSV-1/2 Pool) HSV-2: strain MS (ATCC VR-540) antibody determination in CSF EI M Herpes simplex virus HSV-1: strain Mac Intyre (ATCC VR-539) IgM semi-quantitative 96 x (HSV-1/2 Pool) HSV-2: strain MS (ATCC VR-540) incl. IgG/RF absorbent EI G Herpes simplex virus 1 native, IgG 2/20/200 RU/ml 96 x (HSV-1) glycoprotein C1 EI M Herpes simplex virus 1 (HSV-1) native, IgM semi-quantitative 96 x incl. IgG/RF absorbent glycoprotein C1 EI L G Herpes simplex virus 1 (HSV-1) native, IgG 5/25/50/100 U 96 x antibody determination in CSF glycoprotein C1 EI G Herpes simplex virus 2 native, IgG 2/20/200 RU/ml 96 x (HSV-2) glycoprotein G2 *) Currently not available as IVD in the European Union. 86

87 Microplate ELISA for Infectious Serology (Test Systems) Antibodies Antigen and Ig Class Calibration Format against Antigen Source per Well per Kit EI M Herpes simplex virus 2 (HSV-2) native, IgM semi-quantitative 96 x incl. IgG/RF absorbent glycoprotein G2 EI L G Herpes simplex virus 2 (HSV-2) native, IgG 5/25/50/100 U 96 x antibody determination in CSF glycoprotein G2 EI G Cytomegalovirus cell lysate of MRC-5 cells, IgG 2/20/200 RU/ml 96 x (CMV) strain AD169 EI M Cytomegalovirus (CMV) cell lysate of MRC-5 cells, IgM semi-quantitative 96 x incl. IgG/RF absorbent strain AD169 EI G Cytomegalovirus (CMV) cell lysate of MRC-5 cells, IgG without calibration 96 x avidity determination strain AD169 EI L G Cytomegalovirus (CMV) cell lysate of MRC-5 cells, IgG 5/25/50/100 U 96 x antibody determination in CSF strain AD169 EI G Rubella virus cell lysate of Vero cells, IgG 1/10/200 IU/ml 96 x strain HPV-77 EI M Rubella virus cell lysate of Vero cells, IgM semi-quantitative 96 x incl. IgG/RF absorbent strain HPV-77 EI G Rubella virus cell lysate of Vero cells, IgG without calibration 96 x avidity determination strain HPV-77 EI L G Rubella virus cell lysate of Vero cells, IgG 5/25/50/100 U 96 x antibody determination in CSF strain HPV-77 EI G SARS coronavirus cell lysate of SARS-CoV IgG semi-quantitative 96 x infected cells EI G Measles virus cell lysate of Vero cells, IgG 50/250/5000 miu/ml 96 x strain Edmonston (ATCC VR-24) EI M Measles virus cell lysate of Vero cells, IgM semi-quantitative 96 x incl. IgG/RF absorbent strain Edmonston (ATCC VR-24) EI L G Measles virus cell lysate of Vero cells, IgG 5/25/50/100 U 96 x antibody determination in CSF strain Edmonston (ATCC VR-24) EI G Mumps virus cell lysate of Vero cells, IgG 2/20/200 RU/ml 96 x strain Enders (ATCC VR-106) EI M Mumps virus cell lysate of Vero cells, IgM semi-quantitative 96 x incl. IgG/RF absorbent strain Enders (ATCC VR-106) EI L G Mumps virus cell lysate of Vero cells, IgG 5/25/50/100 U 96 x antibody determination in CSF strain Enders (ATCC VR-106) EI A Varicella zoster virus cell lysate of a human fibroblast IgA semi-quantitative 96 x (VZV) cell line, VZV wild strain Microplate ELISA for Infectious Serology EI G Varicella zoster virus cell lysate of a human fibroblast IgG 50/250/5000 miu/ml 96 x (VZV) cell line, VZV wild strain EI M Varicella zoster virus (VZV) cell lysate of MRC-2 cells, IgM semi-quantitative 96 x incl. IgG/RF absorbent strain VZ-10 EI G Varicella zoster virus (VZV) cell lysate of a human fibroblast IgG without calibration 96 x avidity determination cell line, VZV wild strain EI L G Varicella zoster virus (VZV) cell lysate of a human fibroblast IgG 5/25/50/100 U 96 x antibody determination in CSF cell line, VZV wild strain EI G TBE virus strain IgG 2/20/200 RU/ml 96 x K23 EI M TBE virus strain IgM semi-quantitative 96 x incl. IgG/RF absorbent K23 87

88 Microplate ELISA for Infectious Serology (Test Systems) Antibodies Antigen and Ig Class Calibration Format against Antigen Source per Well per Kit EI L G TBE virus strain IgG 5/25/50/100 U 96 x antibody determination in CSF K23 EI G West Nile Virus cell lysate of West Nile Virus IgG semi-quantitative 96 x infected cells EI M West Nile Virus cell lysate of West Nile Virus IgM semi-quantitative 96 x incl. IgG/RF absorbent infected cells EI G West Nile Virus cell lysate of West Nile Virus IgG without calibration 96 x avidity determination infected cells EI 266b-9601 G Dengue virus highly purified preparation from IgG 2/20/200 RU/ml 96 x Dengue virus particles (type 2) EI 266b-9601 M Dengue virus highly purified preparation from IgM semi-quantitative 96 x incl. IgG/RF absorbent Dengue virus particles (type 2) EI A Respiratory syncytial virus cell lysate of Vero cells, IgA semi-quantitative 96 x (RSV) strain RuS EI G Respiratory syncytial virus cell lysate of Vero cells, IgG 2/20/200 RU/ml 96 x (RSV) strain RuS EI M Respiratory syncytial virus (RSV) cell lysate of Vero cells, IgM semi-quantitative 96 x incl. IgG/RF absorbent strain RuS EI A Adenovirus cell lysate of MRC-5 cells, IgA semi-quantitative 96 x strain Adenoid 6 EI G Adenovirus cell lysate of MRC-5 cells, IgG 2/20/200 RU/ml 96 x strain Adenoid 6 EI M Adenovirus cell lysate of MRC-5 cells, IgM semi-quantitative 96 x incl. IgG/RF absorbent strain Adenoid 6 EI A Influenza virus type A strain Texas IgA semi-quantitative 96 x and strain Singapore EI G Influenza virus type A strain Texas IgG 2/20/200 RU/ml 96 x and strain Singapore EI M Influenza virus type A strain Texas IgM semi-quantitative 96 x incl. IgG/RF absorbent and strain Singapore EI A Influenza virus see individual ELISA IgA semi-quantitative 96 x types A and B (Pool) Microplate ELISA for Infectious Serology EI G Influenza virus see individual ELISA IgG 2/20/200 RU/ml 96 x types A and B (Pool) EI A Influenza virus type B strain IgA semi-quantitative 96 x Hong Kong 5/72 EI G Influenza virus type B strain IgG 2/20/200 RU/ml 96 x Hong Kong 5/72 EI M Influenza virus type B strain IgM semi-quantitative 96 x incl. IgG/RF absorbent Hong Kong 5/72 EI A Parainfluenza virus cell lysate of Vero cells, strains IgA semi-quantitative 96 x types 1-4 (Pool) VP1, Greer, C-234 and M25 EI G Parainfluenza virus cell lysate of Vero cells, strains IgG 2/20/200 RU/ml 96 x types 1-4 (Pool) VP1, Greer, C-234 and M25 EI M Parainfluenza virus types 1-4 cell lysate of Vero cells, strains IgM semi-quantitative 96 x (Pool) incl. IgG/RF absorbent VP1, Greer, C-234 and M25 EI A Epstein-Barr virus capsid antigen native, mixture of several IgA semi-quantitative 96 x (EBV-CA) viral capsid antigens EI G Epstein-Barr virus capsid antigen native, mixture of several IgG 2/20/200 RU/ml 96 x (EBV-CA) viral capsid antigens EI M Epstein-Barr virus capsid antigen native, gp125 of IgM semi-quantitative 96 x (EBV-CA) incl. IgG/RF absorbent EBV infected P3HR1 cells EI G Epstein-Barr virus capsid antigen native, mixture of several IgG without calibration 96 x (EBV-CA) avidity determination viral capsid antigens 88

89 Microplate ELISA for Infectious Serology (Test Systems) Antibodies Antigen and Ig Class Calibration Format against Antigen Source per Well per Kit EI L G Epstein-Barr virus capsid antigen native, mixture of several IgG 5/25/50/100 U 96 x (EBV-CA) antibody determination in CSF viral capsid antigens EI G Epstein-Barr virus nuclear antigen recombinant, expression IgG 2/20/200 RU/ml 96 x (EBNA-1) in insect cells EI A Epstein-Barr virus early antigen recombinant, EBV-EA-D (diffuse), IgA semi-quantitative 96 x (EBV-EA) expression in E. coli EI G Epstein-Barr virus early antigen recombinant, EBV-EA-D (diffuse), IgG 2/20/200 RU/ml 96 x (EBV-EA) expression in E. coli EI M Epstein-Barr virus early antigen recombinant, EBV-EA-D (diffuse), IgM semi-quantitative 96 x (EBV-EA) incl. IgG/RF absorbent expression in E. coli Microplate ELISA for the Determination of Antibodies against Other Antigens (Test Systems) Antibodies Antigen and Ig Class Calibration Format against Antigen Source per Well per Kit Further Microplate ELISA EV A Saccharomyces cerevisiae mannan of IgA 2/20/200 RU/ml 96 x S. cerevisiae EV G Saccharomyces cerevisiae mannan of IgG 2/20/200 RU/ml 96 x S. cerevisiae EV A gliadin gliadin-analogue fusion peptide IgA 2/25/200 RU/ml 96 x 01 3,33 320,00 (GAF-3X) (GAF-3X) EV G gliadin gliadin-analogue fusion peptide IgG 2/25/200 RU/ml 96 x 01 3,33 320,00 (GAF-3X) (GAF-3X) EV E total IgE anti-human IgE IgE 0/10/100/500 IU/ml 96 x (sheep) 89

90 Allercoat 6 System: Basic Reagents and Accessories Previous Reagent Format ZP conjugate pack for 100 analyses ZP reference set for 5 reference curves in double determination ZP washing solution (concentrate) for 5 x 500 ml ZP substrate buffer 5 x 13.5 ml, ready for use (incl. 5 substrate tablets) ZP stop solution 5 x 11 ml, ready for use ZP positive control serum 2.5 ml, ready for use (G5) ZP negative control serum 2.5 ml, ready for use (G5) ZP microplate 96 microplate wells 0.59 (can only be ordered in combination with further reagents) Allercoat 6 System: Allergen Rings (Pharmaceutical Drugs) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP C HSA paper rings with allergen 01 x Human serum albumin EP C C1 paper rings with allergen 01 x Penicilloyl G - HSA EP C C2 paper rings with allergen 01 x Penicilloyl V - HSA EP C C3 paper rings with allergen 01 x A.C.T.H. EP C C4 paper rings with allergen 01 x Chymopapain (Discase) EP C C5 paper rings with allergen 01 x Chymopapain EP C C6 paper rings with allergen 01 x Cephalosporin - HSA EP C C7 paper rings with allergen 01 x Baktrim - HSA EP C C25 paper rings with allergen 01 x Allopurinol - HSA Microplate ELISA for Allergology EP C C49 paper rings with allergen 01 x Propicillin - HSA EP C C53 paper rings with allergen 01 x Alcuronium - HSA EP C C54 paper rings with allergen 01 x Cefalotin - HSA EP C C60 paper rings with allergen 01 x Gentamycin - HSA EP C C61 paper rings with allergen 01 x Erythromycin - HSA EP C C62 paper rings with allergen 01 x Doxycyclin - HSA EP C C64 paper rings with allergen 01 x Piperacillin - HSA EP C C65 paper rings with allergen 01 x Phenylbutazone - HSA 90

91 Allercoat 6 System: Allergen Rings (Pharmaceutical Drugs) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP C C67 paper rings with allergen 01 x Cloxacillin - HSA EP C C68 paper rings with allergen 01 x Articain - HSA EP C C70 paper rings with allergen 01 x Porcine insulin EP C C71 paper rings with allergen 01 x Bovine insulin EP C C73 paper rings with allergen 01 x Human insulin EP C C75 paper rings with allergen 01 x Bromelain - HSA EP C C77 paper rings with allergen 01 x Piroxicam - HSA EP C C78 paper rings with allergen 01 x Ibuprofen - HSA EP C C79 paper rings with allergen 01 x Diclofenac - HSA EP C C80 paper rings with allergen 01 x Tetanus EP C C81 paper rings with allergen 01 x Theophylline/Aminophylline - HSA EP C C82 paper rings with allergen 01 x Lidocaine - HSA EP C C83 paper rings with allergen 01 x Novocaine - HSA EP C C86 paper rings with allergen 01 x Benzocaine - HSA EP C C88 paper rings with allergen 01 x Mepivacaine - HSA EP C C89 paper rings with allergen 01 x Bupivacaine - HSA EP C C90 paper rings with allergen 01 x Propyphenazon - HSA EP C C91 paper rings with allergen 01 x Metamizol - HSA EP C C93 paper rings with allergen 01 x Indomethacin - HSA EP C C94 paper rings with allergen 01 x Tobramycin - HSA EP C C95 paper rings with allergen 01 x Neomycin - HSA EP C C96 paper rings with allergen 01 x Ambroxol - HSA EP C C97 paper rings with allergen 01 x Bromhexine - HSA Microplate ELISA for Allergology EP C C98 paper rings with allergen 01 x Codeine - HSA EP C C99 paper rings with allergen 01 x L-Tyroxin - HSA EP C C100 paper rings with allergen 01 x Prilocain - HSA EP C C101 paper rings with allergen 01 x Phenobarbital - HSA 91

92 Allercoat 6 System: Allergen Rings (Pharmaceutical Drugs) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP C C102 paper rings with allergen 01 x Thiopental - HSA EP C C103 paper rings with allergen 01 x Isoprenaline - HSA EP C C104 paper rings with allergen 01 x Clindamycin - HSA EP C C106 paper rings with allergen 01 x Vitamin B1 - HSA EP C C107 paper rings with allergen 01 x Captopril - HSA EP C C108 paper rings with allergen 01 x Ciprofloxacin - HSA EP C C109 paper rings with allergen 01 x Vitamin B6 - HSA EP C C110 paper rings with allergen 01 x Naproxen - HSA EP C C111 paper rings with allergen 01 x Phenacetin - HSA EP C C112 paper rings with allergen 01 x Diphteria toxin EP C C200 paper rings with allergen 01 x Paracetamol - HSA EP C C201 paper rings with allergen 01 x Acetylsalicylic acid - HSA EP C C203 paper rings with allergen 01 x Ampicillin - HSA EP C C204 paper rings with allergen 01 x Amoxicillin - HSA EP C C205 paper rings with allergen 01 x Tetracycline - HSA EP C C206 paper rings with allergen 01 x Streptomycin - HSA EP C C207 paper rings with allergen 01 x Trimethoprim - HSA EP C C208 paper rings with allergen 01 x Sulfomethoxazol - HSA EP C C209 paper rings with allergen 01 x Pyrazolon - HSA Microplate ELISA for Allergology EP C C210 paper rings with allergen 01 x Muscle Relax. - HSA EP C C223 paper rings with allergen 01 x Benzodiazepine - HSA EP C C300 paper rings with allergen 01 x Procaine - HSA EP C C320 paper rings with allergen 01 x Nifurantin - HSA EP C C379 paper rings with allergen 01 x Butyrophenone/Haloperidol - HSA EP C C424 paper rings with allergen 01 x Prednisolon - HSA EP C C430 paper rings with allergen 01 x Pyrimethamine - HSA EP C C431 paper rings with allergen 01 x Ascorbic acid - HSA 92

93 Allercoat 6 System: Allergen Rings (Mites) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP D D1 paper rings with allergen 01 x Dermatophagoides pteronyssinus EP D D2 paper rings with allergen 01 x Dermatophagoides farinae EP D D4 paper rings with allergen 01 x Dermatophagoides microceras EP D D70 paper rings with allergen 01 x Acarus siro (storage mite) EP D D71 paper rings with allergen 01 x Glycyphagus destructor EP D D72 paper rings with allergen 01 x Tyrophagus putrescentiae EP D D73 paper rings with allergen 01 x Glycyphagus domesticus EP D D74 paper rings with allergen 01 x Euroglyphus maynei Allercoat 6 System: Allergen Rings (Animal Allergens) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP E E1 paper rings with allergen 01 x Cat epithelium EP E E2 paper rings with allergen 01 x Dog hair + epithelium EP E E3 paper rings with allergen 01 x Horse epithelium EP E E4 paper rings with allergen 01 x Cow epithelium EP E E5 paper rings with allergen 01 x Dog squames EP E E6 paper rings with allergen 01 x Guinea pig epithelium EP E E7 paper rings with allergen 01 x Pigeon droppings EP E E8 paper rings with allergen 01 x Mink fur and epithelium EP E E11 paper rings with allergen 01 x Pigeon feathers EP E E12 paper rings with allergen 01 x Pigeon protein EP E E13 paper rings with allergen 01 x Pigeon serum Microplate ELISA for Allergology EP E E14 paper rings with allergen 01 x Canary serum EP E E15 paper rings with allergen 01 x Chicken serum EP E E16 paper rings with allergen 01 x Parrot serum EP E E17 paper rings with allergen 01 x Camel hair (native) + epithelium 93

94 Allercoat 6 System: Allergen Rings (Animal Allergens) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP E E18 paper rings with allergen 01 x Canary droppings EP E E19 paper rings with allergen 01 x Goose droppings EP E E20 paper rings with allergen 01 x Chicken droppings EP E E30 paper rings with allergen 01 x Human hair EP E E50 paper rings with allergen 01 x Finch feathers + droppings EP E E52 paper rings with allergen 01 x Rabbit/hare epithelium EP E E70 paper rings with allergen 01 x Goose feathers EP E E71 paper rings with allergen 01 x Mouse epithelium EP E E72 paper rings with allergen 01 x Mouse urine proteins EP E E73 paper rings with allergen 01 x Rat epithelium EP E E74 paper rings with allergen 01 x Rat urine proteins EP E E75 paper rings with allergen 01 x Rat serum proteins EP E E76 paper rings with allergen 01 x Mouse serum proteins EP E E77 paper rings with allergen 01 x Budgerigar droppings EP E E78 paper rings with allergen 01 x Budgerigar feathers EP E E79 paper rings with allergen 01 x Budgerigar serum proteins EP E E80 paper rings with allergen 01 x Goat epithelium EP E E81 paper rings with allergen 01 x Sheep epithelium EP E E82 paper rings with allergen 01 x Rabbit epithelium Microplate ELISA for Allergology EP E E83 paper rings with allergen 01 x Pig epithelium EP E E84 paper rings with allergen 01 x Hamster epithelium EP E E85 paper rings with allergen 01 x Chicken feathers EP E E86 paper rings with allergen 01 x Duck feathers EP E E89 paper rings with allergen 01 x Mouse droppings EP E E90 paper rings with allergen 01 x Canary feathers EP E E91 paper rings with allergen 01 x Parrot feathers EP E E93 paper rings with allergen 01 x Love bird serum 94

95 Allercoat 6 System: Allergen Rings (Animal Allergens) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP E E94 paper rings with allergen 01 x Ring-necked parakeet droppings EP E E96 paper rings with allergen 01 x Love bird droppings EP E E97 paper rings with allergen 01 x Parrot droppings EP E E98 paper rings with allergen 01 x Chinchilla epithelium + hair EP E E99 paper rings with allergen 01 x Rabbit droppings EP E E100 paper rings with allergen 01 x Duck droppings EP E E103 paper rings with allergen 01 x Wild-pig epithelium + hair EP E E104 paper rings with allergen 01 x Horse hair EP E E110 paper rings with allergen 01 x Ring-necked parakeet feathers EP E E111 paper rings with allergen 01 x Goose down EP E E113 paper rings with allergen 01 x Zebra finch feathers EP E E120 paper rings with allergen 01 x Rat Droppings EP E E121 paper rings with allergen 01 x Turkey feathers EP E E204 paper rings with allergen 01 x Bovine serum albumin EP E E205 paper rings with allergen 01 x Horse serum albumin EP ES ES11 paper rings with 01 x Animals allergen mixture (E1, E3, E4, E5) EP ES ES170 paper rings with 01 x Rodents allergen mixture (E6, E71, E73, E82, E84) EP ES ES171 paper rings with 01 x Feathers allergen mixture (E70, E85, E86) EP ES ES172 paper rings with 01 x Cage birds allergen mixture (E78, E90, E91, E110, E 113) EP ES ES173 paper rings with 01 x Bed feathers allergen mixture (E86, E70) Microplate ELISA for Allergology 95

96 Allercoat 6 System: Allergen Rings (Food) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP F F1 paper rings with allergen 01 x Hen s egg white EP F F2 paper rings with allergen 01 x Cows milk protein EP F F3 paper rings with allergen 01 x Codfish EP F F4 paper rings with allergen 01 x Wheat flour EP F F5 paper rings with allergen 01 x Rye flour EP F F6 paper rings with allergen 01 x Barley flour EP F F7 paper rings with allergen 01 x Oat flour EP F F8 paper rings with allergen 01 x Corn flour (Maize flour) EP F F9 paper rings with allergen 01 x Rice EP F F10 paper rings with allergen 01 x Sesame seeds, ground EP F F11 paper rings with allergen 01 x Buckwheat flour EP F F12 paper rings with allergen 01 x Pea EP F F13 paper rings with allergen 01 x Peanuts EP F F14 paper rings with allergen 01 x Soybean EP F F15 paper rings with allergen 01 x White bean EP F F16 paper rings with allergen 01 x Walnut EP F F17 paper rings with allergen 01 x Hazelnut EP F F18 paper rings with allergen 01 x Brazil nut EP F F19 paper rings with allergen 01 x Sweet chestnut Microplate ELISA for Allergology EP F F20 paper rings with allergen 01 x Almond EP F F21 paper rings with allergen 01 x Herring EP F F22 paper rings with allergen 01 x Trout EP F F23 paper rings with allergen 01 x Shrimp EP F F24 paper rings with allergen 01 x Prawn, North Sea EP F F25 paper rings with allergen 01 x Tomato EP F F26 paper rings with allergen 01 x Pork, raw EP F F27 paper rings with allergen 01 x Beef, raw 96

97 Allercoat 6 System: Allergen Rings (Food) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP F F29 paper rings with allergen 01 x Banana EP F F30 paper rings with allergen 01 x Grapefruit EP F F31 paper rings with allergen 01 x Carrot EP F F32 paper rings with allergen 01 x Lemon EP F F33 paper rings with allergen 01 x Orange EP F F34 paper rings with allergen 01 x Tangerine EP F F35 paper rings with allergen 01 x Potato EP F F36 paper rings with allergen 01 x Coconut EP F F37 paper rings with allergen 01 x Mussel EP F F38 paper rings with allergen 01 x Spinach EP F F39 paper rings with allergen 01 x Cabbage, white EP F F40 paper rings with allergen 01 x Tuna EP F F41 paper rings with allergen 01 x Salmon EP F F43 paper rings with allergen 01 x Brewer s yeast Saccharomyces carlsbergensis EP F F44 paper rings with allergen 01 x Strawberry EP F F45 paper rings with allergen 01 x Baker s yeast Saccharomyces cerevisiae EP F F46 paper rings with allergen 01 x Pepper, green EP F F47 paper rings with allergen 01 x Garlic EP F F49 paper rings with allergen 01 x Apple EP F F50 paper rings with allergen 01 x Grape EP F F51 paper rings with allergen 01 x Soy EP F F55 paper rings with allergen 01 x Eel EP F F56 paper rings with allergen 01 x Sea perch Microplate ELISA for Allergology EP F F57 paper rings with allergen 01 x Goose meat EP F F58 paper rings with allergen 01 x Duck meat EP F F62 paper rings with allergen 01 x Cauliflower, cooked EP F F63 paper rings with allergen 01 x Beef, cooked 97

98 Allercoat 6 System: Allergen Rings (Food) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP F F66 paper rings with allergen 01 x Leek EP F F68 paper rings with allergen 01 x Ovomucoid EP F F70 paper rings with allergen 01 x Swiss cheese EP F F71 paper rings with allergen 01 x Spiny lobster EP F F72 paper rings with allergen 01 x Pineapple EP F F73 paper rings with allergen 01 x Cocoa EP F F74 paper rings with allergen 01 x Coffee EP F F75 paper rings with allergen 01 x Hen s egg yolk EP F F76 paper rings with allergen 01 x alpha-lactalbumin EP F F77 paper rings with allergen 01 x beta-lactoglobulin EP F F78 paper rings with allergen 01 x Casein EP F F79 paper rings with allergen 01 x Gluten (Gliadin) EP F F80 paper rings with allergen 01 x Lobster EP F F81 paper rings with allergen 01 x Cheddar cheese EP F F82 paper rings with allergen 01 x Blue cheese EP F F83 paper rings with allergen 01 x Chicken EP F F84 paper rings with allergen 01 x Kiwi fruit EP F F85 paper rings with allergen 01 x Celery EP F F86 paper rings with allergen 01 x Parsley Microplate ELISA for Allergology EP F F87 paper rings with allergen 01 x Melon EP F F88 paper rings with allergen 01 x Mutton / Lamb EP F F89 paper rings with allergen 01 x Mustard EP F F90 paper rings with allergen 01 x Pepper, black EP F F91 paper rings with allergen 01 x Paprika EP F F92 paper rings with allergen 01 x Nutmeg EP F F93 paper rings with allergen 01 x Mango EP F F94 paper rings with allergen 01 x Pear 98

99 Allercoat 6 System: Allergen Rings (Food) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP F F95 paper rings with allergen 01 x Peach EP F F96 paper rings with allergen 01 x Avocado EP F F97 paper rings with allergen 01 x Cherry EP F F98 paper rings with allergen 01 x Millet EP F F99 paper rings with allergen 01 x Spelt EP F F100 paper rings with allergen 01 x Lettuce EP F F101 paper rings with allergen 01 x Amaranth seeds EP F F102 paper rings with allergen 01 x Malt, made of barley EP F F103 paper rings with allergen 01 x Pecan nut EP F F104 paper rings with allergen 01 x Quinoa EP F F105 paper rings with allergen 01 x Chocolate EP F F106 paper rings with allergen 01 x Kohlrabi EP F F108 paper rings with allergen 01 x Onion EP F F109 paper rings with allergen 01 x Cotton seeds EP F F111 paper rings with allergen 01 x Peppermint tea EP F F113 paper rings with allergen 01 x Black tea EP F F122 paper rings with allergen 01 x Olive, black EP F F126 paper rings with allergen 01 x Peppermint EP F F128 paper rings with allergen 01 x Poppy seed EP F F130 paper rings with allergen 01 x Turkey EP F F132 paper rings with allergen 01 x Bean, green EP F F142 paper rings with allergen 01 x Comfrey EP F F144 paper rings with allergen 01 x Pistachio Microplate ELISA for Allergology EP F F145 paper rings with allergen 01 x Fig EP F F147 paper rings with allergen 01 x Hibiscus tea EP F F148 paper rings with allergen 01 x Plum EP F F149 paper rings with allergen 01 x Papaya 99

100 Allercoat 6 System: Allergen Rings (Food) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP F F150 paper rings with allergen 01 x Edam cheese EP F F151 paper rings with allergen 01 x Courgette (zucchini) EP F F152 paper rings with allergen 01 x Apricot EP F F153 paper rings with allergen 01 x Wheat bran EP F F154 paper rings with allergen 01 x St. John s bread EP F F156 paper rings with allergen 01 x Raspberry EP F F158 paper rings with allergen 01 x Cashew nut EP F F159 paper rings with allergen 01 x Chickpea EP F F160 paper rings with allergen 01 x Sardine EP F F162 paper rings with allergen 01 x Dover sole EP F F163 paper rings with allergen 01 x Pike EP F F164 paper rings with allergen 01 x Swordfish EP F F165 paper rings with allergen 01 x Veal, raw EP F F166 paper rings with allergen 01 x Chinese cabbage EP F F167 paper rings with allergen 01 x Rabbit meat, raw EP F F168 paper rings with allergen 01 x Milk powder EP F F170 paper rings with allergen 01 x Nectarine EP F F171 paper rings with allergen 01 x Currant, red EP F F172 paper rings with allergen 01 x Artichoke Microplate ELISA for Allergology EP F F173 paper rings with allergen 01 x Gurnard EP F F175 paper rings with allergen 01 x Blackberry EP F F176 paper rings with allergen 01 x Aubergine (eggplant) EP F F177 paper rings with allergen 01 x Oyster EP F F178 paper rings with allergen 01 x Haddock EP F F179 paper rings with allergen 01 x Rock shrimp EP F F180 paper rings with allergen 01 x Carp EP F F181 paper rings with allergen 01 x Shark 100

101 Allercoat 6 System: Allergen Rings (Food) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP F F182 paper rings with allergen 01 x Cranberry EP F F185 paper rings with allergen 01 x Cabbage, red EP F F187 paper rings with allergen 01 x Sheep s cheese EP F F188 paper rings with allergen 01 x Soy flour EP F F189 paper rings with allergen 01 x Rye bran EP F F190 paper rings with allergen 01 x Barley bran EP F F191 paper rings with allergen 01 x Pumpkin EP F F192 paper rings with allergen 01 x Quail EP F F193 paper rings with allergen 01 x Spelt, unripe EP F F194 paper rings with allergen 01 x Pepperoni EP F F195 paper rings with allergen 01 x Soy milk EP F F196 paper rings with allergen 01 x Halibut EP F F197 paper rings with allergen 01 x Pine kernels/ nuts EP F F198 paper rings with allergen 01 x Gouda cheese EP F F199 paper rings with allergen 01 x Raisin EP F F201 paper rings with allergen 01 x Chanterelle, yellow EP F F203 paper rings with allergen 01 x Pomegranate EP F F205 paper rings with allergen 01 x Goat s cheese EP F F206 paper rings with allergen 01 x Mackerel EP F F209 paper rings with allergen 01 x Sage tea EP F F210 paper rings with allergen 01 x Wheat EP F F212 paper rings with allergen 01 x Mushroom EP F F213 paper rings with allergen 01 x Rhubarb Microplate ELISA for Allergology EP F F214 paper rings with allergen 01 x Radish EP F F215 paper rings with allergen 01 x Starch (Maize) EP F F217 paper rings with allergen 01 x Soy protein EP F F218 paper rings with allergen 01 x Lecithin 101

102 Allercoat 6 System: Allergen Rings (Food) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP F F219 paper rings with allergen 01 x Goat milk EP F F220 paper rings with allergen 01 x Anchovy EP F F221 paper rings with allergen 01 x Bamboo shoots EP F F222 paper rings with allergen 01 x Pumpkin seeds EP F F224 paper rings with allergen 01 x Beetroot EP F F226 paper rings with allergen 01 x Duck EP F F227 paper rings with allergen 01 x Deer EP F F228 paper rings with allergen 01 x Wild pig EP F F229 paper rings with allergen 01 x Blueberry EP F F230 paper rings with allergen 01 x Caviar EP F F231 paper rings with allergen 01 x Milk, cooked EP F F232 paper rings with allergen 01 x Monkfish EP F F233 paper rings with allergen 01 x Green kale EP F F234 paper rings with allergen 01 x Vanilla pod EP F F235 paper rings with allergen 01 x Lentil EP F F238 paper rings with allergen 01 x alpha-lactalbumin, cooked EP F F239 paper rings with allergen 01 x beta-lactoglobulin, cooked EP F F240 paper rings with allergen 01 x Casein, cooked EP F F244 paper rings with allergen 01 x Cucumber Microplate ELISA for Allergology EP F F247 paper rings with allergen 01 x Honey EP F F254 paper rings with allergen 01 x Plaice EP F F258 paper rings with allergen 01 x Squid (Inkfish) EP F F260 paper rings with allergen 01 x Broccoli EP F F261 paper rings with allergen 01 x Asparagus EP F F265 paper rings with allergen 01 x Caraway EP F F267 paper rings with allergen 01 x Cardamon EP F F268 paper rings with allergen 01 x Clove 102

103 Allercoat 6 System: Allergen Rings (Food) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP F F269 paper rings with allergen 01 x Basil EP F F270 paper rings with allergen 01 x Ginger EP F F271 paper rings with allergen 01 x Anise EP F F272 paper rings with allergen 01 x Tarragon EP F F273 paper rings with allergen 01 x Thyme EP F F274 paper rings with allergen 01 x Marjoram EP F F275 paper rings with allergen 01 x Lovage EP F F276 paper rings with allergen 01 x Fennel EP F F281 paper rings with allergen 01 x Curry EP F F284 paper rings with allergen 01 x Turkey EP F F290 paper rings with allergen 01 x Milk EP F F291 paper rings with allergen 01 x Cauliflower EP F F292 paper rings with allergen 01 x Maize (Corn) EP F F293 paper rings with allergen 01 x Iceberg lettuce EP F F294 paper rings with allergen 01 x Grenadilla (Passion fruit) EP F F296 paper rings with allergen 01 x Gelatine, bovine EP F F297 paper rings with allergen 01 x Potato flour EP F F298 paper rings with allergen 01 x Coconut flakes EP F F299 paper rings with allergen 01 x Parmesan cheese EP F F300 paper rings with allergen 01 x Horse EP F F301 paper rings with allergen 01 x Sorrel EP F F302 paper rings with allergen 01 x Sauerkraut EP F F303 paper rings with allergen 01 x Snail Microplate ELISA for Allergology EP F F304 paper rings with allergen 01 x Savoy cabbage EP F F306 paper rings with allergen 01 x Guar flour EP F F307 paper rings with allergen 01 x Bay leaf EP F F308 paper rings with allergen 01 x Cinnamon 103

104 Allercoat 6 System: Allergen Rings (Food) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP F F309 paper rings with allergen 01 x Coriander EP F F310 paper rings with allergen 01 x Oregano EP F F311 paper rings with allergen 01 x Peppercorn, green EP F F312 paper rings with allergen 01 x Pepper, white EP F F313 paper rings with allergen 01 x Chilli EP F F314 paper rings with allergen 01 x Savory EP F F315 paper rings with allergen 01 x Dill EP F F316 paper rings with allergen 01 x Chervil EP F F317 paper rings with allergen 01 x Balm EP F F318 paper rings with allergen 01 x Rosemary EP F F319 paper rings with allergen 01 x Sage EP F F320 paper rings with allergen 01 x Chive EP F F321 paper rings with allergen 01 x Juniper berry EP F F322 paper rings with allergen 01 x Ovalbumin EP F F323 paper rings with allergen 01 x Camembert EP F F324 paper rings with allergen 01 x Clam EP F F325 paper rings with allergen 01 x Bean, red EP F F326 paper rings with allergen 01 x Currant, black EP F F327 paper rings with allergen 01 x Wine vinegar Microplate ELISA for Allergology EP F F328 paper rings with allergen 01 x Gooseberry EP F F329 paper rings with allergen 01 x Chamomile tea EP F F330 paper rings with allergen 01 x Line seed EP F F331 paper rings with allergen 01 x Brussels sprouts EP F F332 paper rings with allergen 01 x Lychee chinensis EP F F333 paper rings with allergen 01 x Chicory EP F F334 paper rings with allergen 01 x Endive EP F F335 paper rings with allergen 01 x Roquefort 104

105 Allercoat 6 System: Allergen Rings (Food) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP F F336 paper rings with allergen 01 x Glutamate EP FS FS11 paper rings with 01 x Nuts allergen mixture (F13, F17, F18, F20, F36) EP FS FS12 paper rings with 01 x Seafood allergen mixture (F3, F24, F37, F40, F41) EP FS FS13 paper rings with 01 x Mixed cereals allergen mixture (F4, F7, F8, F10, F11) EP FS FS14 paper rings with 01 x Fish allergen mixture (F3, F21, F206, F254) EP FS FS15 paper rings with 01 x Baby food allergen mixture (F1, F2, F4, F13, F14) EP FS FS16 paper rings with 01 x Food I allergen mixture (F15, F12, F235, F14, F13) EP FS FS17 paper rings with 01 x Food II allergen mixture (F4, F5, F6, F99) EP FS FS18 paper rings with 01 x Food III allergen mixture (F11, F8, F18, F101, F104) EP FS FS19 paper rings with 01 x Food IV allergen mixture (F49, F94, F95, F97) EP FS FS20 paper rings with 01 x Food V (safflower oil, allergen mixture U87, F100, F272) EP FS FS21 paper rings with 01 x Fruit I allergen mixture (F29, F33, F95, F49) EP FS FS22 paper rings with 01 x Fruit II allergen mixture (F32, F44, F 72, F94) EP FS FS23 paper rings with 01 x Flours I allergen mixture (F7, F5, F4, F79) EP FS FS24 paper rings with 01 x Vegetables I allergen mixture (F12, F15, F31, F35) EP FS FS25 paper rings with 01 x Vegetables II allergen mixture (F25, F39, F46, F38) EP FS FS26 paper rings with 01 x Vegetables III allergen mixture (F14, F85, F108, F212) Microplate ELISA for Allergology EP FS FS27 paper rings with 01 x Cheese allergen mixture ( F70, F81, F82, F150 ) EP FS FS28 paper rings with 01 x Meat allergen mixture (F26, F27, F88) EP FS FS29 paper rings with 01 x Poultry allergen mixture (F57, F58, F83, F130) EP FS FS30 paper rings with 01 x Flours II allergen mixture (F4, F5, F6, F7, F8) 105

106 Allercoat 6 System: Allergen Rings (Food) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP FS FS31 paper rings with 01 x Food VI allergen mixture (F3, F8, F17, F23, F25) EP FS FS32 paper rings with 01 x Citrus fruits allergen mixture (F30, F32, F33, F34) EP FS FS55 paper rings with 01 x Multiscreen soy I allergen mixture (F14, F51, F188, F195, F217) EP FS FS70 paper rings with 01 x Spices I allergen mixture (F272, F274, F273, F275) EP FS FS71 paper rings with 01 x Spices II allergen mixture (F265, F268, F92, F267) EP FS FS72 paper rings with 01 x Spices III allergen mixture (F271, F270, F269, F276) EP FS FS73 paper rings with 01 x Spices IV allergen mixture (F275, F265, F276, F271) EP FS FS74 paper rings with 01 x Spices V allergen mixture (F274, F273, F269, F111) EP FS FS75 paper rings with 01 x Spices VI allergen mixture (F271,F281,F265,F47) EP FS FS76 paper rings with 01 x Spices VII allergen mixture (F89, F90, F91, F307) Allercoat 6 System: Allergen Rings (Grasses) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP G G1 paper rings with allergen 01 x Sweet vernal grass EP G G2 paper rings with allergen 01 x Bermuda grass Microplate ELISA for Allergology EP G G3 paper rings with allergen 01 x Cocksfoot EP G G4 paper rings with allergen 01 x Fescue, meadow EP G G5 paper rings with allergen 01 x Rye grass, perennial EP G G6 paper rings with allergen 01 x Timothy grass EP G G8 paper rings with allergen 01 x Kentucky blue (June) grass EP G G9 paper rings with allergen 01 x Bentgrass EP G G10 paper rings with allergen 01 x Johnson Grass EP G G11 paper rings with allergen 01 x Brome, smooth 106

107 Allercoat 6 System: Allergen Rings (Grasses) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP G G12 paper rings with allergen 01 x Rye, cultivated EP G G13 paper rings with allergen 01 x Velvet grass EP G G14 paper rings with allergen 01 x Oats, cultivated EP G G16 paper rings with allergen 01 x Meadow foxtail EP G G17 paper rings with allergen 01 x Bahia grass EP G G18 paper rings with allergen 01 x Barley, cultivated EP G G19 paper rings with allergen 01 x Dogtail grass, crested EP G G20 paper rings with allergen 01 x Maize (Corn) EP G G21 paper rings with allergen 01 x Twich (Couch) grass EP G G70 paper rings with allergen 01 x Elymus EP G G71 paper rings with allergen 01 x Oat grass EP G G72 paper rings with allergen 01 x Knot grass EP G G73 paper rings with allergen 01 x Elymus triticoides EP G G74 paper rings with allergen 01 x Phalaris arundinacea EP G G75 paper rings with allergen 01 x Hordeum leporinum EP G G76 paper rings with allergen 01 x Wild oat EP G G100 paper rings with allergen 01 x Russian thistle (Saltwort) EP G G101 paper rings with allergen 01 x Wheat EP GIH IHS1 paper rings with 01 x Inhalation I allergen mixture (G6, W6, W9, W21, T3) EP GIH IHS2 paper rings with 01 x Inhalation II allergen mixture (D2, E1, E2, E3, M6) EP GIH IHS3 paper rings with 01 x Inhalation III allergen mixture (D1, D2, E1, E2, M5) EP GIH IHS4 paper rings with 01 x Inhalation IV allergen mixture (G2, G5, G17, W1, W9, W10) Microplate ELISA for Allergology EP GS GS1 paper rings with 01 x Grass allergen mixture (G1,G2, G5, G6, G10) EP GS GS11 paper rings with 01 x Grass, early flowering allergen mixture (G3, G4, G5, G6, G8) 107

108 Allercoat 6 System: Allergen Rings (Grasses) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP GS GS14 paper rings with 01 x Grass, late flowering allergen mixture (G1, G5, G7, G12, G13) EP GS GS20 paper rings with 01 x Cereal pollen allergen mixture (G12, G14, G18, G20, G101) EP GS GS22 paper rings with 01 x Grass Mix Australia allergen mixture (G2, G5, G6, G8, G10, G17) Allercoat 6 System: Allergen Rings (House Dust) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP H H1 paper rings with allergen 01 x House dust Greer Labs EP H H2 paper rings with allergen 01 x House dust Hollister-Stier EP HS HS12 paper rings with 01 x Mites allergen mixture (H2, D1, D2, I6) Allercoat 6 System: Allergen Rings (Insects) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP I I1 paper rings with allergen 01 x Honeybee, venom EP I I2 paper rings with allergen 01 x White faced hornet (Dolichovespula maculata) Microplate ELISA for Allergology EP I I3 paper rings with allergen 01 x Wasp (Yellow jacket), venom EP I I4 paper rings with allergen 01 x Paper wasp (Polistes apachus) EP I I5 paper rings with allergen 01 x Yellow hornet (Dolichovespula arenaria) EP I I6 paper rings with allergen 01 x German cockroach EP I I7 paper rings with allergen 01 x Bumble bee, venom EP I I10 paper rings with allergen 01 x Paper wasp, venom EP I I11 paper rings with allergen 01 x Phospholipase EP I I12 paper rings with allergen 01 x Black ant 108

109 Allercoat 6 System: Allergen Rings (Insects) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP I I14 paper rings with allergen 01 x Horsefly EP I I15 paper rings with allergen 01 x House fly EP I I70 paper rings with allergen 01 x Fire ant EP I I71 paper rings with allergen 01 x Mosquito (Gnat) EP I I73 paper rings with allergen 01 x Red gnat larvae EP I I74 paper rings with allergen 01 x Waterflea EP I I75 paper rings with allergen 01 x Hornet, venom EP I I76 paper rings with allergen 01 x Trogoderma angustum EP I I77 paper rings with allergen 01 x Rice flour beetle Allercoat 6 System: Allergen Rings (Moulds) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP M M1 paper rings with allergen 01 x Penicillium notatum EP M M2 paper rings with allergen 01 x Cladosporium herbarum EP M M3 paper rings with allergen 01 x Aspergillus fumigatus EP M M4 paper rings with allergen 01 x Mucor racemosus EP M M5 paper rings with allergen 01 x Candida albicans EP M M6 paper rings with allergen 01 x Alternaria tenuis EP M M7 paper rings with allergen 01 x Botrytis cinerea EP M M8 paper rings with allergen 01 x Helminthosporium halodes Microplate ELISA for Allergology EP M M9 paper rings with allergen 01 x Fusarium culmorum EP M M10 paper rings with allergen 01 x Stemphylium botryosum EP M M11 paper rings with allergen 01 x Rhizopus nigricans EP M M12 paper rings with allergen 01 x Aureobasidium pullulans EP M M13 paper rings with allergen 01 x Phoma betae 109

110 Allercoat 6 System: Allergen Rings (Moulds) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP M M14 paper rings with allergen 01 x Epicoccum purpurascens EP M M15 paper rings with allergen 01 x Trichoderma viride EP M M16 paper rings with allergen 01 x Curvularia lunata EP M M17 paper rings with allergen 01 x Aspergillus amstelodami EP M M18 paper rings with allergen 01 x Aspergillus terreus EP M M19 paper rings with allergen 01 x Aspergillus versicolor EP M M20 paper rings with allergen 01 x Neurospora sitophila EP M M21 paper rings with allergen 01 x Paecilomyces spec. EP M M23 paper rings with allergen 01 x Serpula lacrymans EP M M24 paper rings with allergen 01 x Sporobolomyces roseus EP M M25 paper rings with allergen 01 x Aspergillus flavus EP M M26 paper rings with allergen 01 x Ustilago tritici EP M M27 paper rings with allergen 01 x Micropolyspora faeni EP M M28 paper rings with allergen 01 x Aspergillus repens EP M M30 paper rings with allergen 01 x Penicillium roqueforti EP M M31 paper rings with allergen 01 x Penicillium viridicatum EP M M32 paper rings with allergen 01 x Cladosporium cladosporioides EP M M37 paper rings with allergen 01 x Trichophyton mentagrophytes EP M M38 paper rings with allergen 01 x Trichophyton verrucosum Microplate ELISA for Allergology EP M M39 paper rings with allergen 01 x Trichophyton rubrum EP M M40 paper rings with allergen 01 x Fusarium moniliforme EP M M41 paper rings with allergen 01 x Mucor mucedo EP M M42 paper rings with allergen 01 x Aspergillus clavatus EP M M46 paper rings with allergen 01 x Mucor spinosus EP M M47 paper rings with allergen 01 x Cephalosporium acremonium EP M M48 paper rings with allergen 01 x Aspergillus oryzae EP M M49 paper rings with allergen 01 x Aspergillus nidulans 110

111 Allercoat 6 System: Allergen Rings (Moulds) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP M M53 paper rings with allergen 01 x Thermopolyspora polyspora EP M M56 paper rings with allergen 01 x Microsporum canis EP M M58 paper rings with allergen 01 x Cladosporium fulvum EP M M59 paper rings with allergen 01 x Penicillium commune EP M M60 paper rings with allergen 01 x Ulocladium chartarum EP M M61 paper rings with allergen 01 x Penicillium expansum EP M M62 paper rings with allergen 01 x Wine yeast EP M M63 paper rings with allergen 01 x Chaetomium globosum EP M M64 paper rings with allergen 01 x Penicillium chrysogenum EP M M207 paper rings with allergen 01 x Aspergillus niger EP MS MS1 paper rings with 01 x Moulds allergen mixture (M1, M2, M3, M6) EP MS MS2 paper rings with 01 x Aspergilli 1 allergen mixture (M3, M21, M17, M40) EP MS MS3 paper rings with 01 x Aspergilli 2 allergen mixture (M19, M28, M207, M18) EP MS MS4 paper rings with 01 x Penicillia allergen mixture (M1, M22, M28, M30) Allercoat 6 System: Allergen Rings (Further Allergens) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP O O70 paper rings with allergen 01 x Seminal fluid Microplate ELISA for Allergology EP O O71 paper rings with allergen 01 x Seminal plasma EP O O72 paper rings with allergen 01 x Sperm sediment EP O O201 paper rings with allergen 01 x Tobacco dust 111

112 Allercoat 6 System: Allergen Rings (Parasites) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP P P1 paper rings with allergen 01 x Ascaris EP P P2 paper rings with allergen 01 x Echinococcus Allercoat 6 System: Allergen Rings (Trees) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP T T1 paper rings with allergen 01 x Maple EP T T2 paper rings with allergen 01 x Alder EP T T3 paper rings with allergen 01 x Birch EP T T4 paper rings with allergen 01 x Hazel EP T T5 paper rings with allergen 01 x Beech, European EP T T6 paper rings with allergen 01 x Cedar, Japanese EP T T7 paper rings with allergen 01 x Oak EP T T8 paper rings with allergen 01 x Elm EP T T9 paper rings with allergen 01 x Olive EP T T10 paper rings with allergen 01 x Walnut EP T T11 paper rings with allergen 01 x Planetree EP T T12 paper rings with allergen 01 x Willow EP T T13 paper rings with allergen 01 x Mock, orange Microplate ELISA for Allergology EP T T14 paper rings with allergen 01 x Poplar EP T T15 paper rings with allergen 01 x Ash EP T T16 paper rings with allergen 01 x Pine EP T T17 paper rings with allergen 01 x Chestnut, European EP T T18 paper rings with allergen 01 x Eucalyptus EP T T19 paper rings with allergen 01 x Mimosa EP T T20 paper rings with allergen 01 x Privet, common EP T T21 paper rings with allergen 01 x Lilac, common 112

113 Allercoat 6 System: Allergen Rings (Trees) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP T T22 paper rings with allergen 01 x Hawthorn EP T T23 paper rings with allergen 01 x Cypress EP T T24 paper rings with allergen 01 x Lime tree EP T T25 paper rings with allergen 01 x Elder, european EP T T26 paper rings with allergen 01 x Golden chain EP T T27 paper rings with allergen 01 x Cedar, mountain EP T T28 paper rings with allergen 01 x Robinia EP T T29 paper rings with allergen 01 x Morello cherry EP T T31 paper rings with allergen 01 x Melaleuca EP T T32 paper rings with allergen 01 x Orange EP T T33 paper rings with allergen 01 x Poplar, lombardy EP T T34 paper rings with allergen 01 x Almond tree EP T T37 paper rings with allergen 01 x Yew tree EP T T70 paper rings with allergen 01 x Mulberry, white EP T T100 paper rings with allergen 01 x Pecan EP T T101 paper rings with allergen 01 x Walnut, black EP T T102 paper rings with allergen 01 x Mesquite EP T T103 paper rings with allergen 01 x Live Oak EP T T104 paper rings with allergen 01 x Australian pine EP T T107 paper rings with allergen 01 x Cajeput tree EP TS TS1 paper rings with 01 x Trees I allergen mixture (T3, T6, T8, T102, T103) EP TS TS2 paper rings with 01 x Trees II allergen mixture (T1,T3,T5,T11,T14,T103) Microplate ELISA for Allergology EP TS TS15 paper rings with 01 x Trees, early flowering allergen mixture (T2, T4, T8, T12, T14) EP TS TS16 paper rings with 01 x Trees, late flowering allergen mixture (T1, T3, T5, T7, T10) EP TS TS17 paper rings with 01 x Soft woods allergen mixture (WD02, WD14, WD06, WD25) 113

114 Allercoat 6 System: Allergen Rings (Trees) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP TS TS18 paper rings with 01 x Hard woods allergen mixture (WD20, WD17, WD12, WD9) EP TS TS19 paper rings with 01 x Tree Mix Australia allergen mixture (T104, T12, T18, T19, T107) Allercoat 6 System: Allergen Rings (Environmental Allergens) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP U U70 paper rings with allergen 01 x Green coffee bean EP U U71 paper rings with allergen 01 x Castor bean EP U U72 paper rings with allergen 01 x Isphagula (Sem. plant. psyll.) EP U U73 paper rings with allergen 01 x Wild silk EP U U74 paper rings with allergen 01 x Raw silk, fabric EP U U75 paper rings with allergen 01 x TDI Isocyanate - HSA EP U U76 paper rings with allergen 01 x MDI Isocyanate - HSA EP U U77 paper rings with allergen 01 x HDI Isocyanate - HSA EP U U78 paper rings with allergen 01 x Ethylene oxide - HSA EP U U79 paper rings with allergen 01 x Phthalic anhydride - HSA EP U U80 paper rings with allergen 01 x Hops EP U U81 paper rings with allergen 01 x Cotton, yarn and fabric EP U U82 paper rings with allergen 01 x Sheep s wool Microplate ELISA for Allergology EP U U83 paper rings with allergen 01 x Formaldehyde - HSA EP U U84 paper rings with allergen 01 x Ficus benjamini EP U U85 paper rings with allergen 01 x Latex EP U U86 paper rings with allergen 01 x Trimellitic acid anhydride (TMA - HSA) EP U U87 paper rings with allergen 01 x Sunflower seeds EP U U88 paper rings with allergen 01 x Chloramine T - HSA EP U U89 paper rings with allergen 01 x Alpha-amylase EP U U90 paper rings with allergen 01 x Lindane - HSA 114

115 Allercoat 6 System: Allergen Rings (Environmental Allergens) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP U U91 paper rings with allergen 01 x PCP - HSA EP U U92 paper rings with allergen 01 x Pyrethroide - HSA EP U U93 paper rings with allergen 01 x Maleic anhydride - HSA EP U U94 paper rings with allergen 01 x Nickel sulphate - HSA EP U U101 paper rings with allergen 01 x Benzoic acid - HSA EP U U102 paper rings with allergen 01 x Parabene Propylester - HSA EP U U103 paper rings with allergen 01 x Sorbic acid - HSA EP U U106 paper rings with allergen 01 x Benzoicacidester - HSA EP U U107 paper rings with allergen 01 x Buthylester - HSA EP U U108 paper rings with allergen 01 x Mercury - HSA EP U U109 paper rings with allergen 01 x Chromium - HSA EP U U110 paper rings with allergen 01 x Copper - HSA EP U U111 paper rings with allergen 01 x Cobalt - HSA EP U U112 paper rings with allergen 01 x Silver - HSA EP U U113 paper rings with allergen 01 x Gold - HSA EP U U114 paper rings with allergen 01 x Platinum - HSA EP U U115 paper rings with allergen 01 x Tin - HSA EP U U116 paper rings with allergen 01 x Zinc - HSA EP U U117 paper rings with allergen 01 x Formic acid - HSA EP U U118 paper rings with allergen 01 x Chinoline yellow - HSA EP U U119 paper rings with allergen 01 x Yellow orange - HSA EP U U121 paper rings with allergen 01 x Parabenemethylester - HSA EP U U122 paper rings with allergen 01 x Tartrazin - HSA Microplate ELISA for Allergology EP U U124 paper rings with allergen 01 x Palladium - HSA EP U U125 paper rings with allergen 01 x Lanolin EP U U126 paper rings with allergen 01 x Straw dust EP U U127 paper rings with allergen 01 x Rayon 115

116 Allercoat 6 System: Allergen Rings (Environmental Allergens) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP U U128 paper rings with allergen 01 x Linen EP U U129 paper rings with allergen 01 x Jute EP U U130 paper rings with allergen 01 x Amyloglucosidase EP U U131 paper rings with allergen 01 x Acrilan EP U U132 paper rings with allergen 01 x Threshing dust EP U U133 paper rings with allergen 01 x Flax EP U U134 paper rings with allergen 01 x Ceiba pentandra EP U U135 paper rings with allergen 01 x Nylon EP U U136 paper rings with allergen 01 x Silk EP U U137 paper rings with allergen 01 x Terylene EP U U138 paper rings with allergen 01 x Wheat threshing dust EP U U139 paper rings with allergen 01 x Hay dust EP U U140 paper rings with allergen 01 x Sheep s wool, raw EP U U141 paper rings with allergen 01 x Hemicellulase EP U U142 paper rings with allergen 01 x Alcalase EP U U143 paper rings with allergen 01 x Sodium sulfate - HSA EP U U144 paper rings with allergen 01 x Ammonium persulfate - HSA EP U U145 paper rings with allergen 01 x Henna, red EP U U146 paper rings with allergen 01 x Collagen Microplate ELISA for Allergology EP US US11 paper rings with 01 x Environmental screen I allergen mixture (E1, E2, D1, D2, H2) EP US US12 paper rings with 01 x Environmental screen II allergen mixture G12, W6, T3, E1, E5, D1, M2) EP US US13 paper rings with 01 x Synthetic fibres allergen mixture (U131, U127, U135, U137) EP US US14 paper rings with 01 x Natural fibres allergen mixture (U82, U81, U129, U74) EP US US15 paper rings with 01 x Chemicals I allergen mixture (U75, U76, U77, U79) 116

117 Allercoat 6 System: Allergen Rings (Herbal and Flower Pollen) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP W W1 paper rings with allergen 01 x Ragweed, short EP W W2 paper rings with allergen 01 x Ragweed, western EP W W3 paper rings with allergen 01 x Ragweed, tall or giant EP W W4 paper rings with allergen 01 x Ragweed, false EP W W5 paper rings with allergen 01 x Wormwood EP W W6 paper rings with allergen 01 x Mugwort EP W W7 paper rings with allergen 01 x Ox-eye daisy (Marguerite) EP W W8 paper rings with allergen 01 x Dandelion EP W W9 paper rings with allergen 01 x Plantain, english EP W W10 paper rings with allergen 01 x Lamb s quarter EP W W11 paper rings with allergen 01 x Russian thistle (Saltwort) EP W W12 paper rings with allergen 01 x Goldenrod EP W W13 paper rings with allergen 01 x Cocklebur EP W W14 paper rings with allergen 01 x Amaranth EP W W15 paper rings with allergen 01 x Lens-scale EP W W16 paper rings with allergen 01 x Rough Marsh/ Elder EP W W17 paper rings with allergen 01 x Firebush EP W W19 paper rings with allergen 01 x Wall pellitory Parietaria officinalis EP W W21 paper rings with allergen 01 x Wall pellitory, erect Parietaria judaica EP W W22 paper rings with allergen 01 x Chrysanthemum EP W W23 paper rings with allergen 01 x Dahlia EP W W24 paper rings with allergen 01 x Kochia scoparia EP W W25 paper rings with allergen 01 x Geranium Microplate ELISA for Allergology EP W W26 paper rings with allergen 01 x Daffodil EP W W27 paper rings with allergen 01 x Carnation, whole flower EP W W28 paper rings with allergen 01 x Rose EP W W29 paper rings with allergen 01 x Sunflower 117

118 Allercoat 6 System: Allergen Rings (Herbal and Flower Pollen) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP W W30 paper rings with allergen 01 x Tulip EP W W31 paper rings with allergen 01 x Rape EP W W32 paper rings with allergen 01 x Chamomile, wild EP W W33 paper rings with allergen 01 x Primrose EP W W34 paper rings with allergen 01 x Clover, red EP W W38 paper rings with allergen 01 x Marchelder, rough EP W W39 paper rings with allergen 01 x Lupine EP W W40 paper rings with allergen 01 x Hyacinth EP W W41 paper rings with allergen 01 x Alfalfa (Lucerne) EP W W42 paper rings with allergen 01 x Lady s mantle EP W W44 paper rings with allergen 01 x Lily EP W W45 paper rings with allergen 01 x Euphorbia EP W W46 paper rings with allergen 01 x Azalea EP W W47 paper rings with allergen 01 x Hibiscus EP W W48 paper rings with allergen 01 x Yarrow EP W W49 paper rings with allergen 01 x Begonia, flowers and leaves EP W W50 paper rings with allergen 01 x Forsythia EP W W51 paper rings with allergen 01 x Aster EP W W52 paper rings with allergen 01 x Willow herb Microplate ELISA for Allergology EP W W53 paper rings with allergen 01 x Heather EP W W54 paper rings with allergen 01 x Coltsfoot EP W W100 paper rings with allergen 01 x Sorrel, red EP W W101 paper rings with allergen 01 x Spiny pigweed EP W W102 paper rings with allergen 01 x Careless weed EP W W103 paper rings with allergen 01 x Nettle EP WD WD1 paper rings with allergen 01 x Sycamore Maple EP WD WD2 paper rings with allergen 01 x Beech, European 118

119 Allercoat 6 System: Allergen Rings (Herbal and Flower Pollen) Previous Antibodies Substrate Format of Class IgE against per Ring per Package EP WD WD3 paper rings with allergen 01 x Oak EP WD WD4 paper rings with allergen 01 x Ash EP WD WD5 paper rings with allergen 01 x Spruce, European EP WD WD6 paper rings with allergen 01 x Pine EP WD WD7 paper rings with allergen 01 x Limba (Afara) EP WD WD8 paper rings with allergen 01 x Makore EP WD WD9 paper rings with allergen 01 x Mahogany, African EP WD WD12 paper rings with allergen 01 x Ramin EP WD WD14 paper rings with allergen 01 x Fir EP WD WD15 paper rings with allergen 01 x Teak EP WD WD16 paper rings with allergen 01 x Afzelia EP WD WD18 paper rings with allergen 01 x Cherry wood EP WD WD19 paper rings with allergen 01 x Meranti (Red Lauan) EP WD WD21 paper rings with allergen 01 x Acacia EP WD WD22 paper rings with allergen 01 x Sapeli EP WD WD23 paper rings with allergen 01 x Poplar wood EP WD WD24 paper rings with allergen 01 x Lime wood EP WD WD25 paper rings with allergen 01 x Red Cedar EP WS WS1 paper rings with 01 x Weeds I allergen mixture (W1, W6, W9, W10, W11) EP WS WS13 paper rings with 01 x Weeds II allergen mixture (W06, W09, W10, W12) EP WS WS14 paper rings with 01 x Flowers I allergen mixture (W30, W25, W33, W40) EP WS WS15 paper rings with 01 x Flowers II allergen mixture (W51, W22, W23, W7) Microplate ELISA for Allergology EP WS WS16 paper rings with 01 x Weeds III allergen mixture (W1, W6, W7, W8, W12) EP WS WS17 paper rings with 01 x Weeds IV allergen mixture (W9, W10, W11, W100) 119

120 Diagnostics for Indirect Immunofluorescence: Organ-Specific Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA thyroid gland thyroid gland, monkey 10 x 03 (test system) FA (MAb + TAb) unfixed 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA thyroid gland (MAb + TAb) thyroid gland monkey 10 x 03 (test system) FA mitochondria (AMA) kidney rat 10 x 05 (test system) FA (2 BIOCHIPs per field) 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Polyendocrinopathy Mosaic 6 BIOCHIPs per field: 10 x 05 (test system) , FA thyroid gland (MAb + TAb) thyroid gland monkey 20 x 05 (test system) , FB pancreas islets pancreas monkey 10 x 05 (single slides) FB adrenal cortex adrenal gland monkey 20 x 05 (single slides) , ovarial antigens ovary monkey Leydig cells testis monkey parietal cells (PCA) stomach monkey FA EUROPLUS 2 BIOCHIPs per field: 10 x 03 (test system) FA thyroid gland (MAb + TAb) thyroid gland monkey 10 x 05 (test system) FA thyroglobulin (TG) TG BIOCHIPs human 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA pancreas islets pancreas monkey 10 x 03 (test system) FA Crohn s disease autoantigen 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA pancreas islets, GAD pancreas monkey 10 x 03 (test system) FA brain: grey and white matter, cerebellum monkey 10 x 05 (test system) FA Purkinje cell cytoplasm (Yo), (2 BIOCHIPs per field) 10 x 10 (test system) FA Hu and Ri 20 x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies FA parathyroid gland parathyroid monkey 10 x 03 (test system) FA gland 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA adrenal cortex adrenal gland monkey 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA ovarial antigens ovary monkey 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides)

121 Diagnostics for Indirect Immunofluorescence: Organ-Specific Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA * placental antigens placenta monkey 10 x 03 (test system) FA * 10 x 05 (test system) FA * 10 x 10 (test system) FA * 20 x 05 (test system) FB * 10 x 03 (single slides) FB * 10 x 05 (single slides) FB * 10 x 10 (single slides) FB * 20 x 05 (single slides) FA Leydig cells testis monkey 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA spermatozoa smear human 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA pituitary gland antigens pituitary gland monkey 10 x 03 (test system) FA (anterior + posterior lobe) 10 x 05 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 05 (single slides) FA pituitary gland antigens pituitary gland monkey 10 x 05 (test system) FA (anterior lobe) 10 x 10 (test system) FA x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA * hypothalamus antigens nucleus supraopticus/ monkey 10 x 05 (test system) FA * paraventricularis 10 x 10 (test system) FA * 20 x 05 (test system) FB * 10 x 05 (single slides) FB * 10 x 10 (single slides) FB * 20 x 05 (single slides) FA brain: grey and white matter, cerebellum monkey 10 x 03 (test system) FA Purkinje cell cytoplasm (Yo), 10 x 05 (test system) FA Hu and Ri antigen 10 x 10 (test system) FA CV2, Ma, amphiphysin 20 x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Neurology Mosaic 1 3 BIOCHIPs per field: 10 x 03 (test system) FA Yo, Hu, Ri, CV2, Ma, amphiphysin cerebellum monkey 10 x 05 (test system) FA medullated nerves nerves monkey 20 x 05 (test system) FB non-medullated nerves intestinal tissue monkey 10 x 03 (single slides) FB x 05 (single slides) FB x 05 (single slides) FA Neurology Mosaic 2 2 BIOCHIPs per field: 10 x 03 (test system) FA Yo, Hu, Ri, CV2, Ma, amphiphysin cerebellum monkey 10 x 05 (test system) FA medullated nerves nerves monkey 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies *) Currently not available as IVD in the European Union. 121

122 Diagnostics for Indirect Immunofluorescence: Organ-Specific Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA Neurology Mosaic 8 4 BIOCHIPs per field 10 x 05 (test system) FA Yo, Hu, Ri, CV2, Ma, amphiphysin cerebellum monkey 10 x 10 (test system) , FA medullated nerves nerves monkey 20 x 05 (test system) , FB non-medullated nerves intestinal tissue monkey 10 x 05 (single slides) FB pancreas islets pancreas monkey 10 x 10 (single slides) FB x 05 (single slides) FA Neurology Mosaic 13 3 BIOCHIPs per field: 10 x 05 (test system) FA Yo, Hu, Ri, CV2, Ma, amphiphysin cerebellum monkey 10 x 10 (test system) FA non-medullated nerves intestinal tissue monkey 20 x 05 (test system) FA cell nuclei (ANA) HEp-2-cells human 20 x 10 (test system) , FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FB x 10 (single slides) , FA Yo, Hu, Ri, CV2, Ma, amphiphysin cerebellum monkey 10 x 03 (test system) FA non-medullated nerves intestinal tissue monkey 10 x 05 (test system) FA (2 BIOCHIPs per field) 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA medullated nerves nerves (nervus suralis) monkey 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA non-medullated nerves intestinal tissue monkey 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA eye antigens eye monkey 10 x 05 (test system) FA x 05 (test system) FB x 05 (single slides) FB x 05 (single slides) FA retina eye monkey 10 x 05 (test system) FA x 05 (test system) FB x 05 (single slides) FB x 05 (single slides) FA cytoplasm of granulocytes (canca, granulocytes, human 10 x 03 (test system) FA panca), nuclei of granuloc. (GS-ANA) ethanol-fixed (blood group 0) 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies FA granulocytes granulocytes, human 10 x 03 (test system) FA (canca, panca) formaldehyde-fixed (blood group 0) 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Granulocyte Mosaic 1 2 BIOCHIPs per field: 10 x 03 (test system) FA canca, panca, GS-ANA, granulocytes (EOH) human 10 x 05 (test system) FA liver antigens, ANA liver monkey 10 x 10 (test system) FA x 05 (test system) FA x 10 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FB x 10 (single slides)

123 Diagnostics for Indirect Immunofluorescence: Organ-Specific Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA Granulocyte Mosaic 2 2 BIOCHIPs per field: 10 x 03 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 05 (test system) FA canca, panca granulocytes (HCHO) human 10 x 10 (test system) FA x 05 (test system) FA x 10 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FB x 10 (single slides) FA Granulocyte Mosaic 3 4 BIOCHIPs per field: 10 x 03 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 05 (test system) FA canca, panca granulocytes (HCHO) human 10 x 10 (test system) FA cell nuclei (ANA) HEp-2 cells human 20 x 05 (test system) FA liver antigens, ANA liver monkey 20 x 10 (test system) , FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FB x 10 (single slides) FA Granulocyte Mosaic 4 3 BIOCHIPs per field: 10 x 03 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 05 (test system) FA canca, panca granulocytes (HCHO) human 10 x 10 (test system) FA cell nuclei (ANA) HEp-2 cells human 20 x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Granulocyte Mosaic 5 4 BIOCHIPs per field: 10 x 03 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 05 (test system) FA canca, panca granulocytes (HCHO) human 10 x 10 (test system) FA canca, panca granulocytes (MOH) human 20 x 05 (test system) FB liver antigens, ANA liver monkey 10 x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA panca, canca granulocytes (EOH) human 10 x 05 (test system) FA cell nuclei (ANA) HEp-2 cells human 10 x 10 (test system) FA (2 BIOCHIPs per field) 20 x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Granulocyte Mosaic 8 3 BIOCHIPs per field: 10 x 03 (test system) FA canca, panca granulocytes (EOH) human 10 x 05 (test system) FA canca, panca granulocytes (HCHO) human 10 x 10 (test system) FA liver antigens, ANA liver monkey 20 x 05 (test system) FA x 10 (test system) , FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FB x 10 (single slides) FA Granulocyte Mosaic 13 3 BIOCHIPs per field: 10 x 05 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 10 (test system) FA cell nuclei (ANA), canca, panca HEp-2 + granulocytes (EOH) human 20 x 05 (test system) FB canca, panca granulocytes (HCHO) human 10 x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Granulocyte Mosaic 15 2 BIOCHIPs per field: 10 x 03 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 05 (test system) FA cell nuclei (ANA), canca, panca HEp-2 + granulocytes (EOH) human 10 x 10 (test system) FA x 05 (test system) FA x 10 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FB x 10 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies 123

124 Diagnostics for Indirect Immunofluorescence: Organ-Specific Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA Granulocyte Mosaic 16 4 BIOCHIPs per field: 10 x 03 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 05 (test system) FA canca, panca granulocytes (HCHO) human 10 x 10 (test system) FA cell nuclei (ANA) HEp-2 cells human 20 x 05 (test system) FA cell nuclei (ANA), canca, panca HEp-2 + granulocytes (EOH) human 20 x 10 (test system) , FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FB x 10 (single slides) FA Granulocyte Mosaic 17 4 BIOCHIPs per field: 10 x 03 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 05 (test system) FA canca, panca granulocytes (HCHO) human 10 x 10 (test system) FA canca, panca granulocytes (MOH) human 20 x 05 (test system) FB cell nuclei (ANA), canca, panca HEp-2 + granulocytes (EOH) human 10 x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA EUROPLUS Granulocyte Mosaic 20 3 BIOCHIPs per field: 10 x 05 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 10 (test system) , FA panca: myeloperoxidase (MPO) MPO BIOCHIPs 20 x 05 (test system) , FB canca: proteinase 3 (PR3) PR3 BIOCHIPs 10 x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA EUROPLUS Granulocyte Mosaic 22 4 BIOCHIPs per field: 10 x 05 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 10 (test system) , FA canca, panca granulocytes (HCHO) human 20 x 05 (test system) , FB panca: myeloperoxidase (MPO) MPO BIOCHIPs 10 x 05 (single slides) FB canca: proteinase 3 (PR3) PR3 BIOCHIPs 10 x 10 (single slides) FB x 05 (single slides) FA EUROPLUS Granulocyte Mosaic 23 6 BIOCHIPs per field: 10 x 05 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 10 (test system) , FA canca, panca granulocytes (HCHO) human 20 x 05 (test system) , FB cell nuclei (ANA) HEp-2 cells human 10 x 05 (single slides) FB liver antigens, ANA liver monkey 10 x 10 (single slides) , FB panca: myeloperoxidase (MPO) MPO BIOCHIPs 20 x 05 (single slides) , canca: proteinase 3 (PR3) PR3 BIOCHIPs FA EUROPLUS Granulocyte Mosaic 24 6 BIOCHIPs per field: 10 x 05 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 10 x 10 (test system) , FA canca, panca granulocytes (HCHO) human 20 x 05 (test system) , FB cell nuclei (ANA) HEp-2 cells human 10 x 05 (single slides) FB cell nuclei (ANA), canca, panca HEp-2 + granulocytes (EOH) human 10 x 10 (single slides) , FB panca: myeloperoxidase (MPO) MPO BIOCHIPs 20 x 05 (single slides) , canca: proteinase 3 (PR3) PR3 BIOCHIPs FA cytoplasm of granulocytes (canca, granulocytes, human 10 x 05 (test system) FA panca), nuclei of granuloc. (GS-ANA) methanol-fixed (blood group 0) 10 x 10 (test system) FA x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies FA lymphocyte antigens lymphocytes human 10 x 05 (test system) FA (blood group 0) 10 x 10 (test system) FA x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA thrombocyte antigens thrombocytes human 10 x 03 (test system) FA (blood group 0) 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA renal glomeruli (GBM) kidney monkey 10 x 03 (test system) FA renal tubuli 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides)

125 Diagnostics for Indirect Immunofluorescence: Organ-Specific Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA * lung alveoli lung monkey 10 x 03 (test system) FA * 10 x 05 (test system) FA * 10 x 10 (test system) FA * 20 x 05 (test system) FB * 10 x 03 (single slides) FB * 10 x 05 (single slides) FB * 10 x 10 (single slides) FB * 20 x 05 (single slides) FA renal glomeruli (GBM) kidney monkey 10 x 05 (test system) FA lung alveoli lung monkey 10 x 10 (test system) FA (Goodpasture syndrome) (2 BIOCHIPs per field) 20 x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA liver-specific liver monkey 10 x 03 (test system) FA antigens 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Liver Mosaic 1 2 BIOCHIPs per field: 10 x 03 (test system) FA liver-kidney microsomes (LKM) liver rat 10 x 05 (test system) FA LKM, mitochondria (AMA) kidney rat 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Liver Mosaic 2 6 BIOCHIPs per field: 10 x 03 (test system) FA liver antigens, cell nuclei (ANA) liver monkey 10 x 05 (test system) FA AMA M7, heart antigens heart monkey 20 x 05 (test system) FB cell nuclei (ANA) HEp-2 cells human 10 x 03 (single slides) FB liver antigens, LKM, ANA liver rat 10 x 05 (single slides) FB mitochondria (AMA), LKM kidney rat 20 x 05 (single slides) smooth muscles (ASMA) stomach rat FA Liver Mosaic 3 6 BIOCHIPs per field: 10 x 03 (test system) FA liver antigens, cell nuclei (ANA) liver monkey 10 x 05 (test system) FA skeletal muscle musculus iliopsoas monkey 20 x 05 (test system) FB cell nuclei (ANA) HEp-2 cells human 10 x 03 (single slides) FB liver antigens, LKM, cell nuclei (ANA) liver rat 10 x 05 (single slides) FB mitochondria (AMA), LKM kidney rat 20 x 05 (single slides) smooth muscles (ASMA) stomach rat FA Liver Mosaic 6 6 BIOCHIPs per field: 10 x 05 (test system) FA liver antigens, cell nuclei (ANA) liver monkey 20 x 05 (test system) FB AMA M7, heart antigens heart monkey 10 x 05 (single slides) FB cell nuclei (ANA) HEp-2 cells human 20 x 05 (single slides) liver antigens, cell nuclei (ANA) liver rat mitochondria (AMA) kidney rat parietal cells (PCA) stomach monkey FA Liver Mosaic 8 6 BIOCHIPs per field: 10 x 05 (test system) FA liver antigens, cell nuclei (ANA) liver monkey 20 x 05 (test system) FB F-actin, VSM47 rat 10 x 05 (single slides) FB cell nuclei (ANA) HEp-2 cells human 20 x 05 (single slides) liver antigens, LKM, ANA liver rat mitochondria (AMA), LKM kidney rat smooth muscles (ASMA) stomach rat FA EUROPLUS PBC/AIH 6 BIOCHIPs per field: 10 x 03 (test system) FA liver antigens, cell nuclei (ANA) liver monkey 10 x 05 (test system) FA cell nuclei (ANA) HEp-2 cells human 20 x 05 (test system) , FB liver antigens, LKM, ANA liver rat 10 x 03 (single slides) FB mitochondria (AMA), LKM kidney rat 10 x 05 (single slides) FB smooth muscles (ASMA) stomach rat 20 x 05 (single slides) AMA M2, Sp100, LC-1, SLA/LP AMA-M2, Sp100, LC-1, SLA/LP-BIOCHIP Immunofluorescence Tests for the Determination of Autoantibodies *) Currently not available as IVD in the European Union. 125

126 Diagnostics for Indirect Immunofluorescence: Organ-Specific Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA parietal cells stomach monkey 10 x 03 (test system) FA (PCA) 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA parietal cells (PCA) stomach monkey 10 x 03 (test system) FA mitochondria (AMA) kidney rat 10 x 05 (test system) FA (2 BIOCHIPs per field) 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA intrinsic factor intrinsic factor BIOCHIPs 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA EUROPLUS 2 BIOCHIPs per field: 10 x 03 (test system) FA parietal cells (PCA) stomach monkey 10 x 05 (test system) FA intrinsic factor intrinsic factor BIOCHIPs 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA intestinal goblet cells intestinal tissue monkey 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic Intestine/Pancreas 2 BIOCHIPs per field: 10 x 03 (test system) FA intestinal goblet cells intestinal tissue monkey 10 x 05 (test system) FA acini and islets pancreas monkey 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies FA Mosaic Intestine/Pancreas/pANCA/ANA 4 BIOCHIPs per field: 10 x 05 (test system) FA canca, panca granulocytes (EOH) human 20 x 05 (test system) FB intestinal goblet cells intestinal tissue monkey 10 x 05 (single slides) FB acini and islets pancreas monkey 20 x 05 (single slides) cell nuclei (ANA) liver monkey FA acini and islets pancreas monkey 10 x 03 (test system) FA intestinal goblet cells intestinal tissue monkey 10 x 05 (test system) FA saccharomyces cerevisiae fungal smear S. cerevisiae 10 x 10 (test system) FA canca, panca, GS-ANA granulocytes (EOH) human 20 x 05 (test system) FB (4 BIOCHIPs per field) 10 x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA CIBD Profile 1 10 x 03 (test system) FA upper row : 10 x 05 (test system) FB acini and islets pancreas monkey 10 x 03 (single slides) FB intestinal goblet cells intestinal tissue monkey 10 x 05 (single slides) canca, panca, GS-ANA granulocytes (EOH) human bottom row : saccharomyces cerevisiae fungal smear S. cerevisiae format 1003: slides with 3 patient profiles format 1005: slides with 5 patient profiles Saccharomyces cerevisiae as single substrate see page 154 (FV 2841). 126

127 Diagnostics for Indirect Immunofluorescence: Organ-Specific Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA intestinal goblet cells goblet cells EU x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic goblet cells/pancreas 2 BIOCHIPs per field: 10 x 03 (test system) FA intestinal goblet cells goblet cells EU x 05 (test system) FA acini and islets pancreas monkey 20 x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 05 (single slides) FA canca, panca granulocytes (EOH) human 10 x 03 (test system) FA intestinal goblet cells goblet cells EU x 05 (test system) FA acini and islets pancreas monkey 20 x 05 (test system) FB cell nuclei (ANA) liver monkey 10 x 03 (single slides) FB (4 BIOCHIPs per field) 10 x 05 (single slides) FB x 05 (single slides) FA acini and islets pancreas monkey 10 x 03 (test system) FA intestinal goblet cells goblet cells EU x 05 (test system) FA saccharomyces cerevisiae fungal smear S. cerevisiae 20 x 05 (test system) FB canca, panca, GS-ANA granulocytes (EOH) human 10 x 03 (single slides) FB (4 BIOCHIPs per field) 10 x 05 (single slides) FB x 05 (single slides) FA CIBD Profile 2 10 x 03 (test system) FA upper row : 10 x 05 (test system) FA acini and islets pancreas monkey 20 x 05 (test system) FB intestinal goblet cells goblet cells EU x 03 (single slides) FB canca, panca, GS-ANA granulocytes (EOH) human 10 x 05 (single slides) FB bottom row : 20 x 05 (single slides) saccharomyces cerevisiae fungal smear S. cerevisiae format 1003: slides with 3 patient profiles format 1005: slides with 5 patient profiles FA parotid gland parotid gland monkey 10 x 03 (test system) FA excretory ducts 10 x 05 (test system) FA and acini 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA skeletal muscle musculus iliopsoas monkey 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic Skeletal Muscle/Heart Muscle 2 BIOCHIPs per field: 10 x 03 (test system) FA skeletal muscle musculus iliopsoas monkey 10 x 05 (test system) FA heart muscle heart monkey 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA * heart muscle heart rat 10 x 03 (test system) FA * 10 x 05 (test system) FA * 10 x 10 (test system) FA * 20 x 05 (test system) FB * 10 x 03 (single slides) FB * 10 x 05 (single slides) FB * 10 x 10 (single slides) FB * 20 x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies *) Currently not available as IVD in the European Union. 127

128 Diagnostics for Indirect Immunofluorescence: Organ-Specific Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA heart muscle heart monkey 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA heart muscle heart monkey 10 x 05 (test system) FA mitochondria (AMA) kidney rat 10 x 10 (test system) FA (2 BIOCHIPs per field) 20 x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA * cartilage trachea monkey 10 x 03 (test system) FA * 10 x 05 (test system) FA * 10 x 10 (test system) FA * 20 x 05 (test system) FB * 10 x 03 (single slides) FB * 10 x 05 (single slides) FB * 10 x 10 (single slides) FB * 20 x 05 (single slides) FA epidermis: oesophagus monkey 10 x 03 (test system) FA prickle cell desmosomes 10 x 05 (test system) FA epidermal basement membrane 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA epidermis oesophagus monkey 10 x 03 (test system) FA epidermis tongue monkey 10 x 05 (test system) FA (2 BIOCHIPs per field) 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA epidermis: tongue monkey 10 x 03 (test system) FA prickle cell desmosomes 10 x 05 (test system) FA epidermal basement membrane 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies FA keratin oesophagus rat 10 x 03 (test system) FA (filaggrin, RA keratin ) 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA transitional epithelium bladder mucosa rat 10 x 05 (test system) FA (detection of paraneoplastic pemphigus) 10 x 10 (test system) FA x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) *) Currently not available as IVD in the European Union. 128

129 Diagnostics for Indirect Immunofluorescence: Systemic Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA cell nuclei HEp-2 cells human 100 x 10 (test system) , FA (ANA global test) liver monkey 10 x 03 (test system) FA (2 BIOCHIPs per field) 10 x 05 (test system) FA x 10 (test system) FA x 50 (test system) FA x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 10 (test system) FB x 10 (single slides) , FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 50 (single slides) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 10 (single slides) FA cell nuclei (ANA) HEp-2 cells human 10 x 03 (test system) FA mitochondria (AMA) kidney rat 10 x 05 (test system) FA (2 BIOCHIPs per field) 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA EUROPLUS ANA Mosaic 20 4 BIOCHIPs per field: 10 x 05 (test system) FA cell nuclei (ANA) HEp-2 cells human 10 x 10 (test system) , FA cell nuclei (ANA) liver monkey 20 x 05 (test system) , FB SS-A + SS-B SS-A+SS-B BIOCHIPs 10 x 05 (single slides) FB ribosomal P-proteins + Jo-1 rib. P-prot.+Jo-1 BIOCHIPs 10 x 10 (single slides) FB x 05 (single slides) FA EUROPLUS ANA Mosaic 21 4 BIOCHIPs per field: 10 x 05 (test system) FA cell nuclei (ANA) HEp-2 cells human 10 x 10 (test system) , FA cell nuclei (ANA) liver monkey 20 x 05 (test system) , FB nrnp/sm + Sm + SS-A nrnp/sm+sm+ss-a BIOCHIPs 10 x 05 (single slides) FB SS-B + ribosomal P-proteins + Jo-1 SS-B+rib. P-prot.+Jo-1 BIOCHIPs 10 x 10 (single slides) , FB x 05 (single slides) , FA EUROPLUS ANA Mosaic 22 4 BIOCHIPs per field: 10 x 05 (test system) FA cell nuclei (ANA) HEp-2 cells human 10 x 10 (test system) , FA cell nuclei (ANA) liver monkey 20 x 05 (test system) , FB nrnp/sm + Sm + SS-A nrnp/sm+sm+ss-a BIOCHIPs 10 x 05 (single slides) FB SS-B + Scl-70 + Jo-1 SS-B+Scl-70+Jo-1 BIOCHIPs 10 x 10 (single slides) , FB x 05 (single slides) , FA cell nuclei HEp cells human 100 x 10 (test system) , FA (ANA global test) liver monkey 10 x 03 (test system) FA (2 BIOCHIPs per field) 10 x 05 (test system) FA x 10 (test system) FA x 50 (test system) FA x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 10 (test system) FB x 10 (single slides) , FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 50 (single slides) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 10 (single slides) FA cell nuclei (ANA) HEp cells human 10 x 03 (test system) FA mitochondria (AMA) kidney rat 10 x 05 (test system) FA (2 BIOCHIPs per field) 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies 129

130 Diagnostics for Indirect Immunofluorescence: Systemic Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA cell nuclei (ANA) HEp cells human 10 x 05 (test system) FA cell nuclei (ANA) liver rat 10 x 10 (test system) FA (2 BIOCHIPs per field) 20 x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA EUROPLUS ANA Mosaic 20A 4 BIOCHIPs per field: 10 x 05 (test system) FA cell nuclei (ANA) HEp cells human 10 x 10 (test system) , FA cell nuclei (ANA) liver monkey 20 x 05 (test system) , FB SS-A + SS-B SS-A+SS-B BIOCHIPs 10 x 05 (single slides) FB ribosomal P-proteins + Jo-1 rib. P-prot.+Jo-1 BIOCHIPs 10 x 10 (single slides) FB x 05 (single slides) FA EUROPLUS ANA Mosaic 21A 4 BIOCHIPs per field: 10 x 05 (test system) FA cell nuclei (ANA) HEp cells human 10 x 10 (test system) , FA cell nuclei (ANA) liver monkey 20 x 05 (test system) , FB nrnp/sm + Sm + SS-A nrnp/sm+sm+ss-a BIOCHIPs 10 x 05 (single slides) FB SS-B + ribosomal P-proteins + Jo-1 SS-B+rib. P-prot.+Jo-1 BIOCHIPs 10 x 10 (single slides) , FB x 05 (single slides) , FA EUROPLUS ANA Mosaic 22A 4 BIOCHIPs per field: 10 x 05 (test system) FA cell nuclei (ANA) HEp cells human 10 x 10 (test system) , FA cell nuclei (ANA) liver monkey 20 x 05 (test system) , FB nrnp/sm + Sm + SS-A nrnp/sm+sm+ss-a BIOCHIPs 10 x 05 (single slides) FB SS-B + Scl-70 + Jo-1 SS-B+Scl-70+Jo-1 BIOCHIPs 10 x 10 (single slides) , FB x 05 (single slides) , FA cell nuclei (ANA) HEp-2 cells human 100 x 10 (test system) , FA x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 50 (test system) FA x 96 (test system) FA x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 10 (test system) FB x 10 (single slides) , FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 50 (single slides) FB x 96 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 10 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies FA cell nuclei (ANA) HEp cells human 100 x 10 (test system) , FA x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 50 (test system) FA x 96 (test system) FA x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 10 (test system) FB x 10 (single slides) , FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 50 (single slides) FB x 96 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 10 (single slides) FA cell nuclei (ANA) liver rat 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides)

131 Diagnostics for Indirect Immunofluorescence: Systemic Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA cell nuclei (ANA) liver monkey 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA dsdna flagellates Crithidia luciliae 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 03 (test system) FA x 05 (test system) FA x 10 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FA Autoantibody Profile 2 Combination of 30 different tissues per slide for Price and size of kit FB the detection of autoantibodies (BIOCHIP Mosaic). according to prior agreement. FA mitochondria (AMA) kidney rat 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA mitochondria (AMA) kidney rat 10 x 03 (test system) FA smooth muscles (ASMA) stomach rat 10 x 05 (test system) FA (2 BIOCHIPs per field) 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA mitochondria (AMA) kidney mouse 10 x 03 (test system) FA smooth muscles (ASMA) stomach mouse 10 x 05 (test system) FA (2 BIOCHIPs per field) 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA EUROPLUS 2 BIOCHIPs per field: 10 x 03 (test system) FA mitochondria (AMA) kidney rat 10 x 05 (test system) FA M2 antigen M2 BIOCHIPs 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA EUROPLUS 4 BIOCHIPs per field: 10 x 03 (test system) FA mitochondria (AMA) kidney rat 10 x 05 (test system) FA smooth muscles (ASMA) stomach rat 10 x 10 (test system) FA cell nuclei (ANA) HEp-2 cells human 20 x 05 (test system) FB M2 antigen M2 BIOCHIPs 10 x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA mitochondria kidney mouse 10 x 03 (test system) FA (AMA) 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies 131

132 Diagnostics for Indirect Immunofluorescence: Systemic Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA M2 antigen M2 BIOCHIPs 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA F-actin VSM47 rat 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA smooth muscles stomach rat 10 x 03 (test system) FA (ASMA) 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA smooth muscles stomach mouse 10 x 03 (test system) FA (ASMA) 10 x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic Basic Profile 1 3 BIOCHIPs per field: 10 x 03 (test system) FA cell nuclei (ANA) HEp-2 cells human 10 x 05 (test system) FA mitochondria (AMA) kidney rat 10 x 10 (test system) FA smooth muscles (ASMA) stomach rat 20 x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic Basic Profile 2 3 BIOCHIPs per field: 10 x 03 (test system) FA cell nuclei (ANA) liver rat 10 x 05 (test system) FA mitochondria (AMA) kidney rat 10 x 10 (test system) FA smooth muscles (ASMA) stomach rat 20 x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies FA Mosaic Basic Profile 3 4 BIOCHIPs per field: 10 x 03 (test system) FA cell nuclei (ANA) HEp-2 cells human 10 x 05 (test system) FA cell nuclei (ANA), liver antigens liver monkey 10 x 10 (test system) FA mitochondria (AMA) kidney rat 20 x 05 (test system) FB smooth muscles (ASMA) stomach rat 10 x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic Basic Profile 4 5 BIOCHIPs per field: 10 x 05 (test system) FA cell nuclei (ANA) HEp-2 cells human 20 x 05 (test system) FB cell nuclei (ANA), liver antigens liver monkey 10 x 05 (single slides) FB dsdna flagellates Crithidia luciliae 20 x 05 (single slides) mitochondria (AMA) kidney rat smooth muscles (ASMA) stomach rat FA Mosaic Basic Profile 6 6 BIOCHIPs per field: 10 x 05 (test system) FA skeletal muscle musculus iliopsoas monkey 20 x 05 (test system) FB heart muscle heart monkey 10 x 05 (single slides) FB cell nuclei (ANA) HEp-2 cells human 20 x 05 (single slides) cell nuclei (ANA), liver antigens liver monkey mitochondria (AMA) kidney rat smooth muscles (ASMA) stomach rat 132

133 Diagnostics for Indirect Immunofluorescence: Systemic Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA Mosaic Basic Profile 7 3 BIOCHIPs per field: 10 x 03 (test system) FA cell nuclei (ANA) HEp-2 cells human 10 x 05 (test system) FA cell nuclei (ANA) liver monkey 10 x 10 (test system) FA mitochondria (AMA) kidney rat 20 x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic Basis Profile 25 4 BIOCHIPs per field: 10 x 03 (test system) FA cell nuclei (ANA) liver rat 10 x 05 (test system) FA cell nuclei (ANA) liver monkey 10 x 10 (test system) FA mitochondria (AMA) kidney rat 20 x 05 (test system) FB smooth muscles (ASMA) stomach rat 10 x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic Basic Profile 1A 3 BIOCHIPs per field: 10 x 03 (test system) FA cell nuclei (ANA) HEp cells human 10 x 05 (test system) FA mitochondria (AMA) kidney rat 10 x 10 (test system) FA smooth muscles (ASMA) stomach rat 20 x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic Basic Profile 3A 4 BIOCHIPs per field: 10 x 03 (test system) FA cell nuclei (ANA) HEp cells human 10 x 05 (test system) FA cell nuclei (ANA), liver antigens liver monkey 10 x 10 (test system) FA mitochondria (AMA) kidney rat 20 x 05 (test system) FB smooth muscles (ASMA) stomach rat 10 x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic Basic Profile 13B 4 BIOCHIPs per field: 10 x 03 (test system) FA cell nuclei (ANA) HEp-2 cells human 10 x 05 (test system) FA cell nuclei (ANA) liver rat 10 x 10 (test system) FA mitochondria (AMA) kidney rat 20 x 05 (test system) FB smooth muscles (ASMA) stomach rat 10 x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic Basic Profile 3C 4 BIOCHIPs per field: 10 x 03 (test system) FA cell nuclei (ANA) HEp cells human 10 x 05 (test system) FA cell nuclei (ANA) liver rat 10 x 10 (test system) FA mitochondria (AMA) kidney rat 20 x 05 (test system) FB smooth muscles (ASMA) stomach rat 10 x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA Mosaic Basic Profile 25C 4 BIOCHIPs per field: 10 x 05 (test system) FA cell nuclei (ANA) HEp cells human 10 x 10 (test system) FA cell nuclei (ANA) liver mouse 20 x 05 (test system) FB smooth muscles (ASMA) stomach mouse 10 x 05 (single slides) FB mitochondria (AMA) kidney mouse 10 x 10 (single slides) FB x 05 (single slides) FA A endomysium, reticulin oesophagus monkey 10 x 03 (test system) FA A 10 x 05 (test system) FA A 10 x 10 (test system) FA A 20 x 05 (test system) FB A 10 x 03 (single slides) FB A 10 x 05 (single slides) FB A 10 x 10 (single slides) FB A 20 x 05 (single slides) FA G 10 x 03 (test system) FA G 10 x 05 (test system) FA G 10 x 10 (test system) FA G 20 x 05 (test system) FB G 10 x 03 (single slides) FB G 10 x 05 (single slides) FB G 10 x 10 (single slides) FB G 20 x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies 133

134 Diagnostics for Indirect Immunofluorescence: Systemic Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA A EUROPLUS 2 BIOCHIPs per field: 10 x 03 (test system) FA A endomysium, reticulin oesophagus monkey 10 x 05 (test system) FA A gliadin gliadin BIOCHIPs wheat 10 x 10 (test system) FA A 20 x 05 (test system) FB A 10 x 03 (single slides) FB A 10 x 05 (single slides) FB A 10 x 10 (single slides) FB A 20 x 05 (single slides) FA G 10 x 03 (test system) FA G 10 x 05 (test system) FA G 10 x 10 (test system) FA G 20 x 05 (test system) FB G 10 x 03 (single slides) FB G 10 x 05 (single slides) FB G 10 x 10 (single slides) FB G 20 x 05 (single slides) FA A endomysium, reticulin small intestine monkey 10 x 03 (test system) FA A 10 x 05 (test system) FA A 10 x 10 (test system) FA A 20 x 05 (test system) FB A 10 x 03 (single slides) FB A 10 x 05 (single slides) FB A 10 x 10 (single slides) FB A 20 x 05 (single slides) FA G 10 x 03 (test system) FA G 10 x 05 (test system) FA G 10 x 10 (test system) FA G 20 x 05 (test system) FB G 10 x 03 (single slides) FB G 10 x 05 (single slides) FB G 10 x 10 (single slides) FB G 20 x 05 (single slides) FA A EUROPLUS 2 BIOCHIPs per field: 10 x 03 (test system) FA A endomysium, reticulin small intestine monkey 10 x 05 (test system) FA A gliadin gliadin BIOCHIPs wheat 10 x 10 (test system) FA A 20 x 05 (test system) FB A 10 x 03 (single slides) FB A 10 x 05 (single slides) FB A 10 x 10 (single slides) FB A 20 x 05 (single slides) FA G 10 x 03 (test system) FA G 10 x 05 (test system) FA G 10 x 10 (test system) FA G 20 x 05 (test system) FB G 10 x 03 (single slides) FB G 10 x 05 (single slides) FB G 10 x 10 (single slides) FB G 20 x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies FA A endomysium, reticulin oesophagus monkey 10 x 03 (test system) FA A endomysium, reticulin small intestine monkey 10 x 05 (test system) FA A (2 BIOCHIPs per field) 10 x 10 (test system) FA A 20 x 05 (test system) FB A 10 x 03 (single slides) FB A 10 x 05 (single slides) FB A 10 x 10 (single slides) FB A 20 x 05 (single slides) FA G 10 x 03 (test system) FA G 10 x 05 (test system) FA G 10 x 10 (test system) FA G 20 x 05 (test system) FB G 10 x 03 (single slides) FB G 10 x 05 (single slides) FB G 10 x 10 (single slides) FB G 20 x 05 (single slides) FA A EUROPLUS 4 BIOCHIPs per field: 10 x 05 (test system) FA A endomysium, reticulin small intestine monkey 10 x 10 (test system) , FA A gliadin gliadin BIOCHIPs wheat 20 x 05 (test system) , FB A endomysium, reticulin oesophagus monkey 10 x 05 (single slides) FB A endomysium, reticulin liver monkey 10 x 10 (single slides) FB A 20 x 05 (single slides) FA G 10 x 05 (test system) FA G 10 x 10 (test system) , FA G 20 x 05 (test system) , FB G 10 x 05 (single slides) FB G 10 x 10 (single slides) FB G 20 x 05 (single slides)

135 Diagnostics for Indirect Immunofluorescence: Systemic Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA A endomysium, reticulin small intestinum monkey 10 x 05 (test system) FA A endomysium, reticulin oesophagus monkey 10 x 10 (test system) FA A endomysium, reticulin liver monkey 20 x 05 (test system) FB A (3 BIOCHIPs per field) 10 x 05 (single slides) FB A 10 x 10 (single slides) FB A 20 x 05 (single slides) FA G 10 x 05 (test system) FA G 10 x 10 (test system) FA G 20 x 05 (test system) FB G 10 x 05 (single slides) FB G 10 x 10 (single slides) FB G 20 x 05 (single slides) FA A endomysium liver monkey 10 x 03 (test system) FA A 10 x 05 (test system) FA A 10 x 10 (test system) FA A 20 x 05 (test system) FB A 10 x 03 (single slides) FB A 10 x 05 (single slides) FB A 10 x 10 (single slides) FB A 20 x 05 (single slides) FA G 10 x 03 (test system) FA G 10 x 05 (test system) FA G 10 x 10 (test system) FA G 20 x 05 (test system) FB G 10 x 03 (single slides) FB G 10 x 05 (single slides) FB G 10 x 10 (single slides) FB G 20 x 05 (single slides) FA A EUROPLUS 2 BIOCHIPs per field: 10 x 03 (test system) FA A endomysium, reticulin liver monkey 10 x 05 (test system) FA A gliadin gliadin BIOCHIPs wheat 10 x 10 (test system) FA A 20 x 05 (test system) FB A 10 x 03 (single slides) FB A 10 x 05 (single slides) FB A 10 x 10 (single slides) FB A 20 x 05 (single slides) FA G 10 x 03 (test system) FA G 10 x 05 (test system) FA G 10 x 10 (test system) FA G 20 x 05 (test system) FB G 10 x 03 (single slides) FB G 10 x 05 (single slides) FB G 10 x 10 (single slides) FB G 20 x 05 (single slides) Gliadin as single substrate see page 154 (FV 3011). FA A endomysium, reticulin small intestine monkey 10 x 03 (test system) FA A endomysium, reticulin liver monkey 10 x 05 (test system) FA A (2 BIOCHIPs per field) 10 x 10 (test system) FA A 20 x 05 (test system) FB A 10 x 03 (single slides) FB A 10 x 05 (single slides) FB A 10 x 10 (single slides) FB A 20 x 05 (single slides) FA A EUROPLUS 3 BIOCHIPs per field: 10 x 03 (test system) FA A endomysium liver monkey 10 x 05 (test system) FA A endomysium, reticulin small intestine monkey 10 x 10 (test system) FA A gliadin gliadin BIOCHIPs wheat 20 x 05 (test system) FB A 10 x 03 (single slides) FB A 10 x 05 (single slides) FB A 10 x 10 (single slides) FB A 20 x 05 (single slides) FA G 10 x 03 (test system) FA G 10 x 05 (test system) FA G 10 x 10 (test system) FA G 20 x 05 (test system) FB G 10 x 03 (single slides) FB G 10 x 05 (single slides) FB G 10 x 10 (single slides) FB G 20 x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies 135

136 Diagnostics for Indirect Immunofluorescence: Systemic Autoantibodies Antibodies Substrate Species Format against Slides x Fields per Field per Kit FA A endomysium umbilical cord human 10 x 05 (test system) FA A 10 x 10 (test system) FA A 20 x 05 (test system) FB A 10 x 05 (single slides) FB A 10 x 10 (single slides) FB A 20 x 05 (single slides) FA endothelial cells HUVEC human 10 x 03 (test system) FA x 05 (test system) FA x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) FA endothelial cells musculus iliopsoas monkey 10 x 03 (test system) FA endothelial cells HUVEC human 10 x 05 (test system) FA (2 BIOCHIPs per field) 10 x 10 (test system) FA x 05 (test system) FB x 03 (single slides) FB x 05 (single slides) FB x 10 (single slides) FB x 05 (single slides) Immunofluorescence Tests for the Determination of Autoantibodies 136

137 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI G Bordetella IgG bacterial Bordetella 10 x 03 (test system) FI G pertussis smear pertussis 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Bordetella pertussis IgG bacterial B. pertussis 10 x 05 (test system) FI G Bordetella parapertussis smears B. parapertussis 10 x 10 (test system) FI G (2 BIOCHIPs per field) 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Bordetella IgG bacterial Bordetella 10 x 03 (test system) FI G parapertussis smear parapertussis 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G * Haemophilus IgG bacterial Haemophilus 10 x 05 (test system) FI G * influenzae smear influenzae 10 x 10 (test system) FI G * 20 x 05 (test system) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) FI A Helicobacter IgA bacterial Helicobacter 10 x 05 (test system) FI A pylori smear pylori 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G * Campylobacter jejuni IgG bacterial C. jejuni 10 x 05 (test system) FI G * Campylobacter coli smears C. coli 10 x 10 (test system) FI G * (2 BIOCHIPs per field) 20 x 05 (test system) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) FI G * Campylobacter IgG bacterial Campylobacter 10 x 05 (test system) FI G * jejuni smear jejuni 10 x 10 (test system) FI G * 20 x 05 (test system) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) FI G * Campylobacter IgG bacterial Campylobacter 10 x 05 (test system) FI G * coli smear coli 10 x 10 (test system) FI G * 20 x 05 (test system) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) FI G * Klebsiella IgG bacterial Klebsiella 10 x 05 (test system) FI G * pneumoniae smear pneumoniae 10 x 10 (test system) FI G * 20 x 05 (test system) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) Immunofluorescence Tests for Infectious Serology *) Currently not available as IVD in the European Union. Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 137

138 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI G Treponema IgG bacterial smear T. pallidum 10 x 03 (test system) FI G (FTA-ABS) plus FTA sorbent 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M Treponema IgM bacterial smear T. pallidum 10 x 03 (test system) FI M (FTA-ABS) plus FTA sorbent 10 x 05 (test system) FI M plus RF absorbent 10 x 10 (test system) FI M 20 x 05 (test system) FK Treponema bacterial smear T. pallidum 10 x 03 (single slides) FK (FTA-ABS) 10 x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Treponema IgG bacterial smear T. pallidum 10 x 03 (test system) FI G (FTA-ABS) (2 BIOCHIPs per field) T. phagedenis 10 x 05 (test system) FI G plus FTA sorbent 10 x 10 (test system) FI G 20 x 05 (test system) FI M Treponema IgM bacterial smear T. pallidum 10 x 03 (test system) FI M (FTA-ABS) (2 BIOCHIPs per field) T. phagedenis 10 x 05 (test system) FI M plus FTA sorbent 10 x 10 (test system) FI M plus RF absorbent 20 x 05 (test system) FK Treponema T. pallidum 10 x 03 (single slides) FK (FTA-ABS) bacterial smear T. phagedenis 10 x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Borrelia IgG bacterial Borrelia 10 x 03 (test system) FI G afzelii smear afzelii 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G EUROPLUS IgG 2 BIOCHIPs per field: 10 x 05 (test system) FI G Borrelia afzelii bacterial smear B. afzelii 10 x 10 (test system) FI G VlsE antigen VlsE-BIOCHPs recombinant 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI M EUROPLUS IgM 2 BIOCHIPs per field: 10 x 05 (test system) FI M Borrelia afzelii bacterial smear B. afzelii 10 x 10 (test system) FI M OspC antigen OspC-BIOCHIPs B. burgdorferi 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Immunofluorescence Tests for Infectious Serology FI G Borrelia IgG bacterial Borrelia 10 x 03 (test system) FI G burgdorferi smear burgdorferi 10 x 05 (test system) FI G (CH) (CH) 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Borrelia IgG bacterial Borrelia 10 x 03 (test system) FI G burgdorferi smear burgdorferi 10 x 05 (test system) FI G (USA) (USA) 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 138

139 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI G Borrelia IgG bacterial Borrelia 10 x 05 (test system) FI G garinii smear garinii 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Borrelia afzelii IgG bacterial B. afzelii 10 x 05 (test system) FI G Borrelia burgdorferi (USA) smears B. burgdorferi (USA) 10 x 10 (test system) FI G (2 BIOCHIPs per field) 20 x 05 (test system) FI M IgM 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G EUROPLUS IgG 4 BIOCHIPs per field: 10 x 05 (test system) FI G Borrelia afzelii bacterial smear B. afzelii 10 x 10 (test system) FI G Borrelia burgdorferi (USA) bacterial smear B. burgdorferi (USA) 20 x 05 (test system) FI M OspC antigen IgM OspC-BIOCHIPs B. burgdorferi 10 x 05 (test system) FI M VlsE antigen VlsE-BIOCHPs recombinant 10 x 10 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Borrelia afzelii IgG bacterial B. afzelii 10 x 03 (test system) FI G Borrelia burgdorferi (CH) smears B. burgdorferi (CH) 10 x 05 (test system) FI G (2 BIOCHIPs per field) 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Borrelia afzelii IgG bacterial B. afzelii 10 x 05 (test system) FI G Borrelia burgdorferi (USA) smears B. burgdorferi (USA) 20 x 05 (test system) FI M Borrelia garinii IgM (3 BIOCHIPs per field) B. garinii 10 x 05 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 05 (single slides) FI G Borrelia afzelii IgG bacterial B. afzelii 10 x 05 (test system) FI G Borrelia burgdorferi (CH) smears B. burgdorferi (CH) 10 x 10 (test system) FI G Borrelia burgdorferi (USA) (4 BIOCHIPs per field) B. burgd. (USA) 20 x 05 (test system) FI M Borrelia garinii IgM B. garinii 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G * Listeria IgG bacterial Listeria 10 x 05 (test system) FI G * monocytogenes smear monocytogenes 10 x 10 (test system) FI G * 1/2a 1/2a 20 x 05 (test system) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) FI G * Listeria IgG bacterial Listeria 10 x 03 (test system) FI G * monocytogenes smears monocytogenes 10 x 05 (test system) FI G * 1/2a and 4b (2 BIOCHIPs per field) 1/2a and 4b 10 x 10 (test system) FI G * 20 x 05 (test system) FK * 10 x 03 (single slides) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) Immunofluorescence Tests for Infectious Serology *) Currently not available as IVD in the European Union. Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 139

140 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI G * Listeria IgG bacterial Listeria 10 x 05 (test system) FI G * monocytogenes smear monocytogenes 10 x 10 (test system) FI G * 4b 4b 20 x 05 (test system) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) FI P BIOCHIP Sequence IgM bacterial Legionella 10 x 01 (test system) FI P Legionella pneumophila smears pneumophila 20 x 01 (test system) FI P serotypes 1-14 (1 BIOCHIP 50 x 01 (test system) FK per serotype) 10 x 01 (single slides) FK x 01 (single slides) FK x 01 (single slides) FI P BIOCHIP Sequence Legionella IgM bacterial smears L. pneumophila 10 x 01 (test system) FI P Legionella pneumophila 1-14 (1 BIOCHIP per L. jordanis 20 x 01 (test system) FI P L. jordanis, L. bozemanii, serotype or species) L. bozemanii 50 x 01 (test system) FK L. gormanii, L. micdadei, L. gormanii 10 x 01 (single slides) FK L. dumoffii, L. longbeachae L. micdadei 20 x 01 (single slides) FK L. dumoffii 50 x 01 (single slides) L. longbeachae FI P Legionella pneumophila IgM bacterial Legionella 10 x 05 (test system) FI P mixture smears pneumophila 10 x 10 (test system) FI P mixture (4 BIOCHIPs per field) 20 x 05 (test system) FK mixture x 05 (single slides) FK mixture x 10 (single slides) FK x 05 (single slides) FI 215b-1003 P Legionella pneumophila IgM bacterial Legionella 10 x 03 (test system) FI 215b-1005 P mixture smear pneumophila 10 x 05 (test system) FI 215b-1010 P 10 x 10 (test system) FI 215b-2005 P 20 x 05 (test system) FK 215b x 03 (single slides) FK 215b x 05 (single slides) FK 215b x 10 (single slides) FK 215b x 05 (single slides) FI 215b P Legionella pneumophila IgM bacterial Legionella 10 x 03 (test system) FI 215b P mixture smears pneumophila 10 x 05 (test system) FI 215b P mixture (2 BIOCHIPs per field) 10 x 10 (test system) FI 215b P 20 x 05 (test system) FK 215b x 03 (single slides) FK 215b x 05 (single slides) FK 215b x 10 (single slides) FK 215b x 05 (single slides) FI 215d-1005 P Legionella pneumophila IgM bacterial Legionella 10 x 05 (test system) FI 215d-1010 P mixture smear pneumophila 10 x 10 (test system) FI 215d-2005 P 20 x 05 (test system) FK 215d x 05 (single slides) FK 215d x 10 (single slides) FK 215d x 05 (single slides) FI 215f-1005 P Legionella pneumophila IgM bacterial Legionella 10 x 05 (test system) FI 215f-1010 P mixture smear pneumophila 10 x 10 (test system) FI 215f-2005 P 20 x 05 (test system) FK 215f x 05 (single slides) FK 215f x 10 (single slides) FK 215f x 05 (single slides) Immunofluorescence Tests for Infectious Serology FI 215h-1005 P Legionella pneumophila IgM bacterial Legionella 10 x 05 (test system) FI 215h-1010 P mixture smear pneumophila 10 x 10 (test system) FI 215h-2005 P 20 x 05 (test system) FK 215h x 05 (single slides) FK 215h x 10 (single slides) FK 215h x 05 (single slides) FI P Legionella pneumophila IgM bacterial Legionella 10 x 05 (test system) FI P serotype 1 smear pneumophila 10 x 10 (test system) FI P 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Slides with any one of the Legionella pneumophila serotypes 2 (FK 2152) to 14 (FK 2164) can be delivered as well. *) Currently not available as IVD in the European Union. Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 140

141 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI G Legionella IgG bacterial Legionella 10 x 05 (test system) FI G longbeachae smear longbeachae 10 x 10 (test system) FI G 20 x 05 (test system) FI P IgM 10 x 05 (test system) FI P 10 x 10 (test system) FI P 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI 216f P Mosaic Legionella non-pneumophila IgM 10 x 05 (test system) FI 216f P Legionella jordanis 6 BIOCHIPs per field: L. jordanis 20 x 05 (test system) FK 216f Legionella bozemanii bacterial L. bozemanii 10 x 05 (single slides) FK 216f Legionella gormanii smears L. gormanii 20 x 05 (single slides) Legionella micdadei L. micdadei Legionella dumoffii L. dumoffii Legionella longbeachae L. longbeachae Slides with the Legionella non-pneumophila species jordanis (FK 2165), gormanii (FK 2166), dumoffii (FK 2167), micdadei (FK 2169) or bozemanii (FK 216a) can be delivered as well. FI G * Yersinia IgG bacterial Yersinia 10 x 03 (test system) FI G * enterocolitica smear enterocolitica 10 x 05 (test system) FI G * O:3 10 x 10 (test system) FI G * (for diagnosing various 20 x 05 (test system) FK * forms of arthritis) 10 x 03 (single slides) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) Slides for diagnosis of various forms of arthritis with any one of the Yersinia enterocolitica types O:4 (FK 2174), O:6 (FK 2176) or O:9 (FK 2179) can be delivered as well. FI G * BIOCHIP Mosaic IgG 4 BIOCHIPs per field: 10 x 05 (test system) FI G * Yersinia enterocolitica bacterial Yersinia 10 x 10 (test system) FI G * O:3, O:4, O:6, O:9 smears enterocolitica 20 x 05 (test system) FK * (for diagnosing various 10 x 05 (single slides) FK * forms of arthritis) 10 x 10 (single slides) FK * 20 x 05 (single slides) FI A Chlamydia IgA infected cells EU x 03 (test system) FI A trachomatis 10 x 05 (test system) FI A 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Chlamydia trachomatis IgA infected EU x 03 (test system) FI A Chlamydia pneumoniae cells EU x 05 (test system) FI A (2 BIOCHIPs per field) 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Immunofluorescence Tests for Infectious Serology *) Currently not available as IVD in the European Union. Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 141

142 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI A * anti-chlamydia MIF IgA infected EU x 05 (test system) FI A * Chlamydia trachomatis (elementary bodies) EU x 10 (test system) FI A * Chlamydia pneumoniae and non-infected cells EU x 05 (test system) FI G * Chlamydia psittaci IgG (4 BIOCHIPs per field) 10 x 05 (test system) FI G * 10 x 10 (test system) FI G * 20 x 05 (test system) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) FI A Chlamydia IgA infected EU x 03 (test system) FI A pneumoniae cells 10 x 05 (test system) FI A 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI 219b-1003 G Bartonella IgG infected EU x 03 (test system) FI 219b-1005 G henselae cells 10 x 05 (test system) FI 219b-1010 G 10 x 10 (test system) FI 219b-2005 G 20 x 05 (test system) FK 219b-1003 G 10 x 03 (single slides) FK 219b-1005 G 10 x 05 (single slides) FK 219b-1010 G 10 x 10 (single slides) FK 219b-2005 G 20 x 05 (single slides) FI 219b-1003 M IgM infected and non- EU x 03 (test system) FI 219b-1005 M infected cells 10 x 05 (test system) FI 219b-1010 M (2 BIOCHIPs per field) 10 x 10 (test system) FI 219b-2005 M 20 x 05 (test system) FK 219b-1003 M 10 x 03 (single slides) FK 219b-1005 M 10 x 05 (single slides) FK 219b-1010 M 10 x 10 (single slides) FK 219b-2005 M 20 x 05 (single slides) FI 219b G Bartonella henselae IgG infected cells EU x 05 (test system) FI 219b G Bartonella quintana infected cells EU x 10 (test system) FI 219b G (2 BIOCHIPs per field) 20 x 05 (test system) FK 219b G 10 x 05 (single slides) FK 219b G 10 x 10 (single slides) FK 219b G 20 x 05 (single slides) FI 219b M IgM infected and non- EU x 05 (test system) FI 219b M infected cells EU x 10 (test system) FI 219b M (4 BIOCHIPs per field) 20 x 05 (test system) FK 219b M 10 x 05 (single slides) FK 219b M 10 x 10 (single slides) FK 219b M 20 x 05 (single slides) Immunofluorescence Tests for Infectious Serology FI 219d-1005 G Bartonella IgG infected EU x 05 (test system) FI 219d-1010 G quintana cells 10 x 10 (test system) FI 219d-2005 G 20 x 05 (test system) FK 219d-1005 G 10 x 05 (single slides) FK 219d-1010 G 10 x 10 (single slides) FK 219d-2005 G 20 x 05 (single slides) FI 219d-1005 M IgM infected and non- EU x 05 (test system) FI 219d-1010 M infected cells 10 x 10 (test system) FI 219d-2005 M (2 BIOCHIPs per field) 20 x 05 (test system) FK 219d-1005 M 10 x 05 (single slides) FK 219d-1010 M 10 x 10 (single slides) FK 219d-2005 M 20 x 05 (single slides) *) Currently not available as IVD in the European Union. Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 142

143 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI A Mycoplasma IgA infected and non- EU x 05 (test system) FI A hominis infected cells 10 x 10 (test system) FI A (2 BIOCHIPs per field) 20 x 05 (test system) FI G IgG 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Mycoplasma hominis IgA infected cells EU x 05 (test system) FI A Ureaplasma urealyticum infected cells EU x 10 (test system) FI A non-infected cells EU x 05 (test system) FI G IgG (3 BIOCHIPs per field) 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Mycoplasma IgA infected and non- EU x 03 (test system) FI A pneumoniae infected cells 10 x 05 (test system) FI A (2 BIOCHIPs per field) 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Ureaplasma IgA infected and non- EU x 05 (test system) FI A urealyticum infected cells 10 x 10 (test system) FI A (2 BIOCHIPs per field) 20 x 05 (test system) FI G IgG 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Leishmania donovani IgA protozoan Leishmania 10 x 03 (test system) FI A (promastigot) smear donovani 10 x 05 (test system) FI A 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Immunofluorescence Tests for Infectious Serology Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 143

144 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI G EUROPLUS IgG 2 BIOCHIPs per field: 10 x 05 (test system) FI G Plasmodium falciparum rec. antigens Plasmodium 10 x 10 (test system) FI G HRP-2 + MSP-2 falciparum 20 x 10 (test system) , FK Plasmodium vivax rec. antigens Plasmodium 10 x 05 (single slides) FK MSP + CSP vivax 10 x 10 (single slides) FK x 10 (single slides) , FI A Echinococcus IgA frozen Echinococcus 10 x 03 (test system) FI A granulosus sections larvae 10 x 05 (test system) FI A 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A * Toxoplasma IgA protozoan Toxoplasma 10 x 03 (test system) FI A * gondii smear gondii 10 x 05 (test system) FI A * 10 x 10 (test system) FI A * 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FI X (avidity test) 10 x 03 (test system) FI X 10 x 05 (test system) FI X 10 x 10 (test system) FI X 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G TO.R.C.H. Profile IgG 4 BIOCHIPs per field: 10 x 03 (test system) FI G Toxoplasma gondii protozoan smear T. gondii 10 x 05 (test system) FI G Rubella virus infected cells EU x 10 (test system) FI G Cytomegalovirus infected cells EU x 05 (test system) FK HSV mixture (1+2) infected cells EU x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G * HIV-1 IgG infected and non- EU x 05 (test system) FI G * infected cells 10 x 10 (test system) FI G * (2 BIOCHIPs per field) 20 x 05 (test system) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) Immunofluorescence Tests for Infectious Serology FI G * BIOCHIP Mosaic IgG 4 BIOCHIPs per field: 10 x 05 (test system) FI G * HIV-1/HIV-2 infected and non- EU 61, EU x 05 (test system) FK * infected cells 10 x 05 (single slides) FK * 20 x 05 (single slides) FI G * HIV-2 IgG infected and EU x 05 (test system) FI G * non-infected cells 10 x 10 (test system) FI G * (2 BIOCHIPs per field) 20 x 05 (test system) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) *) Currently not available as IVD in the European Union. Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 144

145 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI G Herpes simplex virus 1 IgG infected EU x 03 (test system) FI G (HSV-1) cells 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G BIOCHIP Mosaic IgG 2 BIOCHIPs per field: 10 x 03 (test system) FI G HSV-1/HSV-2 infected EU x 05 (test system) FI G cells 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Herpes simplex virus 2 IgG infected EU x 03 (test system) FI G (HSV-2) cells 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Human herpes virus 6 IgG infected EU x 03 (test system) FI G (HHV-6) cells 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Cytomegalovirus IgA infected EU x 03 (test system) FI A (CMV) cells 10 x 05 (test system) FI A 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Rubella virus IgG infected EU x 05 (test system) FI G cells 10 x 10 (test system) FI G 20 x 05 (test system) FI X (avidity test) 10 x 05 (test system) FI X 10 x 10 (test system) FI X 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Immunofluorescence Tests for Infectious Serology Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 145

146 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI A SARS coronavirus IgA infected and non- EU x 10 (test system) FI A infected cells 20 x 10 (test system) FI G IgG (2 BIOCHIPs per field) 10 x 10 (test system) FI G 20 x 10 (test system) FI M IgM 10 x 10 (test system) FI M 20 x 10 (test system) FK x 10 (single slides) FK x 10 (single slides) FI G Measles virus IgG infected EU x 03 (test system) FI G cells 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Mumps virus IgG infected EU x 03 (test system) FI G cells 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Varicella zoster virus IgA infected EU x 03 (test system) FI A (VZV) cells 10 x 05 (test system) FI A 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Immunofluorescence Tests for Infectious Serology FI A TBE virus IgA infected and non- EU x 05 (test system) FI A infected cells 10 x 10 (test system) FI A (2 BIOCHIPs per field) 20 x 05 (test system) FI G IgG 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G Flavivirus Mosaic 1 IgG 4 BIOCHIPs per field: 10 x 05 (test system) FI G TBE virus infected cells EU x 10 (test system) FI G West-Nile virus infected cells EU x 10 (test system) , FI M Japanese encephalitis virus IgM infected cells EU x 05 (test system) FI M Yellow fever virus infected cells EU x 10 (test system) FI M 20 x 10 (test system) , FK x 05 (single slides) FK x 10 (single slides) FK x 10 (single slides) , Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 146

147 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI G Flavivirus Profile 2 IgG 10 x 05 (test system) FI G upper row : 20 x 05 (test system) , FK TBE virus infected cells EU x 05 (single slides) FK West Nile virus infected cells EU x 05 (single slides) , Japanese encephalitis virus infected cells EU 14 Yellow fever virus infected cells EU 14 bottom row : Dengue virus infected cells EU 14 types 1 to 4 FI G West Nile virus IgG infected and non- EU x 05 (test system) FI G infected cells 10 x 10 (test system) FI G (2 BIOCHIPs per field) 20 x 05 (test system) FI M IgM 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FI X (avidity test) 10 x 05 (test system) FI X 10 x 10 (test system) FI X 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI G * Japanese encephalitis virus IgG infected and non- EU x 05 (test system) FI G * infected cells 10 x 10 (test system) FI G * (2 BIOCHIPs per field) 20 x 05 (test system) FI M * IgM 10 x 05 (test system) FI M * 10 x 10 (test system) FI M * 20 x 05 (test system) FK * 10 x 05 (single slides) FK * 10 x 10 (single slides) FK * 20 x 05 (single slides) FI G Yellow fever virus IgG infected and non- EU x 05 (test system) FI G infected cells 10 x 10 (test system) FI G (2 BIOCHIPs per field) 20 x 05 (test system) FI M IgM 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI 266a G Mosaic Dengue virus IgG 4 BIOCHIPs per field: 10 x 03 (test system) FI 266a G types 1 to 4 infected EU x 05 (test system) FI 266a G cells 10 x 10 (test system) FI 266a G 20 x 05 (test system) FI 266a M IgM 10 x 03 (test system) FI 266a M 10 x 05 (test system) FI 266a M 10 x 10 (test system) FI 266a M 20 x 05 (test system) FK 266a x 03 (single slides) FK 266a x 05 (single slides) FK 266a x 10 (single slides) FK 266a x 05 (single slides) FI A Respiratory syncytial virus IgA infected EU x 03 (test system) FI A (RSV) cells 10 x 05 (test system) FI A 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Immunofluorescence Tests for Infectious Serology *) Currently not available as IVD in the European Union. Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 147

148 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI A Adenovirus IgA infected EU x 03 (test system) FI A type 3 cells 10 x 05 (test system) FI A 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Influenza virus type A IgA infected EU x 03 (test system) FI A cells 10 x 05 (test system) FI A 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Influenza virus type A IgA infected EU x 03 (test system) FI A Influenza virus type B cells EU x 05 (test system) FI A (2 BIOCHIPs per field) 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Immunofluorescence Tests for Infectious Serology FI A Influenza virus type B IgA infected EU x 03 (test system) FI A cells 10 x 05 (test system) FI A 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 148

149 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI A Mosaic Parainfluenza virus IgA infected EU 18/9 10 x 03 (test system) FI A types 1-4 cells 10 x 05 (test system) FI A (4 BIOCHIPs per field) 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Mosaic Coxsackie virus IgA 9 BIOCHIPs per field: 10 x 03 (test system) FI A Coxsackie virus infected EU x 05 (test system) FI A types A7, A9, A16, A24, cells 20 x 05 (test system) , FI G B1, B2, B3, B4, B5 IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 20 x 05 (test system) , FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 20 x 05 (test system) , FK x 03 (single slides) FK x 05 (single slides) FK x 05 (single slides) FI A Mosaic Coxsackie virus A types IgA 4 BIOCHIPs per field: 10 x 03 (test system) FI A Coxsackie virus infected EU x 05 (test system) FI A types A7, A9, A16, A24 cells 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 05 (single slides) FI A Mosaic Coxsackie virus B types IgA 6 BIOCHIPs per field: 10 x 03 (test system) FI A Coxsackie virus infected EU x 05 (test system) FI A types B1, B2, B3, B4, B5, B6 cells 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 05 (single slides) FI A Coxsackie virus type A7 IgA infected EU x 03 (test system) FI A Coxsackie virus type B1 cells EU x 05 (test system) FI A (2 BIOCHIPs per field) 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Immunofluorescence Tests for Infectious Serology Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 149

150 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI G Enterovirus Mosaic 1 IgG 3 BIOCHIPs per field: 10 x 05 (test system) FI G Coxsackie virus type A7 infected cells EU x 10 (test system) FI M Coxsackie virus type B1 IgM infected cells EU x 05 (test system) FI M Echo virus type 7 infected cells EU x 10 (test system) FK x 05 (single slides) FK x 10 (single slides) FI A Coxsackie virus type B1 IgA infected EU x 05 (test system) FI A cells 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Coxsackie virus type A7 IgA infected EU x 05 (test system) FI A cells 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI 275a-1005 A Echo virus IgA infected EU x 05 (test system) FI 275a-1010 A type 7 cells 10 x 10 (test system) FI 275a-2005 A 20 x 05 (test system) FI 275a-1005 G IgG 10 x 05 (test system) FI 275a-1010 G 10 x 10 (test system) FI 275a-2005 G 20 x 05 (test system) FI 275a-1005 M IgM 10 x 05 (test system) FI 275a-1010 M 10 x 10 (test system) FI 275a-2005 M 20 x 05 (test system) FK 275a x 05 (single slides) FK 275a x 10 (single slides) FK 275a x 05 (single slides) FI 277a G * Sandfly fever virus Mosaic 1 IgG 4 BIOCHIPs per field: 10 x 05 (test system) FI 277a G * Sandfly fever virus infected cells EU x 10 (test system) FI 277a G * (types Sicilian, Naples, Toscana, Cyprus) 20 x 05 (test system) FI 277a M * IgM 10 x 05 (test system) FI 277a M * 10 x 10 (test system) FI 277a M * 20 x 10 (test system) , FK 277a * 10 x 05 (single slides) FK 277a * 10 x 10 (single slides) FK 277a * 20 x 05 (single slides) Immunofluorescence Tests for Infectious Serology FI 278h G Hanta virus Mosaic 1 IgG 6 BIOCHIPs per field: 10 x 05 (test system) FI 278h G types Hantaan, Sin Nombre, Puumala, infected EU x 10 (test system) , FI 278h G Dobrava, Seoul, Saaremaa cells 20 x 10 (test system) , FI 278h M IgM 10 x 05 (test system) FI 278h M 10 x 10 (test system) , FI 278h M 20 x 10 (test system) , FK 278h x 05 (single slides) FK 278h x 10 (single slides) FK 278h x 10 (single slides) , FI 278h G Hanta virus Mosaic Eurasia1 IgG 6 BIOCHIPs per field: 10 x 05 (test system) FI 278h G types Hantaan, Puumala, infected and non- EU x 10 (test system) FI 278h G Dobrava, Seoul, Saaremaa infected cells 20 x 10 (test system) , FI 278h M IgM 10 x 05 (test system) FI 278h M 10 x 10 (test system) FI 278h M 20 x 10 (test system) , FK 278h x 05 (single slides) FK 278h x 10 (single slides) FK 278h x 10 (single slides) , *) Currently not available as IVD in the European Union. Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 150

151 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI A Epstein-Barr IgA expressing P3HR1 10 x 03 (test system) FI A virus capsid antigen cells 10 x 05 (test system) FI A (EBV-CA) 10 x 10 (test system) FI A 20 x 05 (test system) FK A 10 x 03 (single slides) FK A 10 x 05 (single slides) FK A 10 x 10 (single slides) FK A 20 x 05 (single slides) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FK G 10 x 03 (single slides) FK G 10 x 05 (single slides) FK G 10 x 10 (single slides) FK G 20 x 05 (single slides) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK M 10 x 03 (single slides) FK M 10 x 05 (single slides) FK M 10 x 10 (single slides) FK M 20 x 05 (single slides) FI X (avidity test) 10 x 03 (test system) FI X 10 x 05 (test system) FI X 10 x 10 (test system) FI X 20 x 05 (test system) FI A EBV capsid antigen (EBV-CA) IgA expressing P3HR1 10 x 03 (test system) FI A EBV early antigen (EBV-EA) cells EU x 05 (test system) FI A (2 BIOCHIPs per field) 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI X (avidity test) 10 x 03 (test system) FI X 10 x 05 (test system) FI X 10 x 10 (test system) FI X 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI C Epstein-Barr virus expressing Raji 10 x 03 (test system) FI C nuclear antigen (EBNA, cells 10 x 05 (test system) FI C complement-fixing antibodies) 10 x 10 (test system) FI C 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI A Epstein-Barr IgA expressing EU x 03 (test system) FI A virus early antigen cells 10 x 05 (test system) FI A (EBV-EA) 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI X (avidity test) 10 x 03 (test system) FI X 10 x 05 (test system) FI X 10 x 10 (test system) FI X 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) Immunofluorescence Tests for Infectious Serology Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 151

152 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI BIOCHIP Sequence EBV 10 x 01 (test system) FI fields A & B: EBV-CA (IgG) expressing cells P3HR1 10 x 02 (test system) FI field C: EBV-CA (IgM) expressing cells P3HR1 10 x 10 (test system) FI field D: EBV-EA expressing cells EU x 01 (test system) FI field E: EBNA expressing cells Raji 20 x 02 (test system) FK format 1001: per slide one patient 10 x 01 (single slides) FK format 1002: per slide two patients 10 x 02 (single slides) FK format 1010: per slide ten patients 10 x 10 (single slides) FK x 01 (single slides) FK x 02 (single slides) FI X BIOCHIP Sequence EBV (avidity test) 10 x 01 (test system) FI X fields A & B: EBV-CA (IgG) expressing cells P3HR1 10 x 02 (test system) FI X field C: EBV-CA (IgM) expressing cells P3HR1 10 x 10 (test system) FI X field D: EBV-EA expressing cells EU x 01 (test system) FI X field E: EBNA expressing cells Raji 20 x 02 (test system) format 1001: per slide one patient format 1002: per slide two patients format 1010: per slide ten patients BIOCHIP Mosaics for infectious serology. One slide for one patient (e.g. FI G) or two patients (e.g. FI G), respectively, for the combination of substrates see pages 54/55. FI G Respiratory Tract Profile 1 IgG 10 x 01 (test system) FI G (consisting of 20 different substrates) 10 x 02 (test system) FI G 20 x 01 (test system) FI G 20 x 02 (test system) FI M IgM 10 x 01 (test system) FI M 10 x 02 (test system) FI M 20 x 01 (test system) FI M 20 x 02 (test system) FK x 01 (single slides) FK x 02 (single slides) FK x 01 (single slides) FK x 02 (single slides) FI G Exanthema Profile 1 IgG 10 x 01 (test system) FI G (consisting of 20 different substrates) 10 x 02 (test system) FI M * IgM 10 x 01 (test system) FI M * 10 x 02 (test system) FK * 10 x 01 (single slides) FK * 10 x 02 (single slides) FI G * Lymphadenitis Profile 1 IgG 10 x 01 (test system) FI G * (consisting of 20 different substrates) 10 x 02 (test system) FI M * IgM 10 x 01 (test system) FI M * 10 x 02 (test system) FK * 10 x 01 (single slides) FK * 10 x 02 (single slides) FI G Central Nervous System Profile 1 IgG 10 x 01 (test system) FI G (consisting of 20 different substrates) 10 x 02 (test system) FI M * IgM 10 x 01 (test system) FI M * 10 x 02 (test system) FK * 10 x 01 (single slides) FK * 10 x 02 (single slides) Immunofluorescence Tests for Infectious Serology FI G Myocarditis Profile 1 IgG 10 x 01 (test system) FI G (consisting of 16 different substrates) 10 x 02 (test system) FI M IgM 10 x 01 (test system) FI M 10 x 02 (test system) FK x 01 (single slides) FK x 02 (single slides) FI G Infectarthritis Profile 1 IgG 10 x 01 (test system) FI G (consisting of 12 different substrates) 10 x 02 (test system) FI M IgM 10 x 01 (test system) FI M 10 x 02 (test system) FK x 01 (single slides) FK x 02 (single slides) *) Currently not available as IVD in the European Union. Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 152

153 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI G Infectarthritis Profile 21: The Tropics IgG 10 x 03 (test system) FI G upper row : 10 x 05 (test system) FI M Chikungunya virus IgM infected cells EU x 03 (test system) FI M bottom row : 10 x 05 (test system) FK Dengue virus infected EU x 03 (single slides) FK types 1 to 4 cells 10 x 05 (single slides) FI G Gastrointestinal Tract Profile 1 IgG 10 x 01 (test system) FI G (consisting of 12 different substrates) 10 x 02 (test system) FI M IgM 10 x 01 (test system) FI M 10 x 02 (test system) FK x 01 (single slides) FK x 02 (single slides) FI G Accompanying Hepatitis Profile 1 IgG 10 x 01 (test system) FI G (consisting of 11 different substrates) 10 x 02 (test system) FI M IgM 10 x 01 (test system) FI M 10 x 02 (test system) FK x 01 (single slides) FK x 02 (single slides) FI G Ophthalmology Profile 1 IgG 10 x 01 (test system) FI G (consisting of 8 different substrates) 10 x 02 (test system) FI M IgM 10 x 01 (test system) FI M 10 x 02 (test system) FK x 01 (single slides) FK x 02 (single slides) FI G * STD Profile 1 IgG 10 x 01 (test system) FI G * (consisting of 12 different substrates) 10 x 02 (test system) FI M * IgM 10 x 01 (test system) FI M * 10 x 02 (test system) FK * 10 x 01 (single slides) FK * 10 x 02 (single slides) FI G * Pregnancy Profile 1 IgG 10 x 01 (test system) FI G * (consisting of 8 different substrates) 10 x 02 (test system) FI M * IgM 10 x 01 (test system) FI M * 10 x 02 (test system) FK * 10 x 01 (single slides) FK * 10 x 02 (single slides) FI G Otitis Profile 1 IgG 10 x 01 (test system) FI G (consisting of 16 different substrates) 10 x 02 (test system) FI M IgM 10 x 01 (test system) FI M 10 x 02 (test system) FK x 01 (single slides) FK x 02 (single slides) FI G Fever Profile 1: South East Asia IgG 10 x 03 (test system) FI G upper row : 10 x 05 (test system) FI M Chikungunya virus IgM infected cells EU x 03 (test system) FI M Japanese encephalitis virus infected cells EU x 05 (test system) FK Plasmodium falciparum HRP-2 + MSP-2 Pl. falciparum 10 x 03 (single slides) FK Plasmodium vivax MSP + CSP Pl. vivax 10 x 05 (single slides) bottom row : Dengue virus infected EU 14 types 1 to 4 cells format 1003: slides with 3 patient profiles format 1005: slides with 5 patient profiles FI P Candida albicans IgM fungal smear Candida albicans 10 x 05 (test system) FI P Candida glabrata fungal smear Candida glabrata 20 x 05 (test system) FK Candida krusei fungal smear Candida krusei 10 x 05 (single slides) FK Candida tropicalis fungal smear Candida tropicalis 20 x 05 (single slides) Candida parapsilosis fungal smear Candida parapsilosis (5 BIOCHIPs per field) Immunofluorescence Tests for Infectious Serology *) Currently not available as IVD in the European Union. Depending on the immunoglobulin class to be investigated, A, G or M appears behind the order number. Some test systems have not been evaluated for IgA or IgM. 153

154 Diagnostics for Indirect Immunofluorescence: Infectious Serology Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit FI A Candida IgA fungal Candida 10 x 03 (test system) FI A albicans smear albicans 10 x 05 (test system) FI A 10 x 10 (test system) FI A 20 x 05 (test system) FI G IgG 10 x 03 (test system) FI G 10 x 05 (test system) FI G 10 x 10 (test system) FI G 20 x 05 (test system) FI M IgM 10 x 03 (test system) FI M 10 x 05 (test system) FI M 10 x 10 (test system) FI M 20 x 05 (test system) FK x 03 (single slides) FK x 05 (single slides) FK x 10 (single slides) FK x 05 (single slides) FI 293a-1005 G Chikungunya virus IgG infected and non- EU x 05 (test system) FI 293a-1010 G infected cells 10 x 10 (test system) FI 293a-2005 G (2 BIOCHIPs per field) 20 x 05 (test system) FI 293a-1005 M IgM 10 x 05 (test system) FI 293a-1010 M 10 x 10 (test system) FI 293a-2005 M 20 x 05 (test system) FK 293a x 05 (single slides) FK 293a x 10 (single slides) FK 293a x 05 (single slides) Diagnostics for Indirect Immunofluorescence: Further Antigens Antibodies Ig Class Substrate Species Format against Slides x Fields per Field per Kit Immunofluorescence Tests for Infectious Serology FV A Saccharomyces IgA fungal Saccharomyces 10 x 03 (test system) FV A cerevisiae smear cerevisiae 10 x 05 (test system) FV A 10 x 10 (test system) FV A 20 x 05 (test system) FV G IgG 10 x 03 (test system) FV G 10 x 05 (test system) FV G 10 x 10 (test system) FV G 20 x 05 (test system) FV M IgM 10 x 03 (test system) FV M 10 x 05 (test system) FV M 10 x 10 (test system) FV M 20 x 05 (test system) FX x 03 (single slides) FX x 05 (single slides) FX x 10 (single slides) FX x 05 (single slides) FV A gliadin IgA gliadin BIOCHIPs wheat 10 x 03 (test system) FV A 10 x 05 (test system) FV A 10 x 10 (test system) FV A 20 x 05 (test system) FV G IgG 10 x 03 (test system) FV G 10 x 05 (test system) FV G 10 x 10 (test system) FV G 20 x 05 (test system) FX x 03 (single slides) FX x 05 (single slides) FX x 10 (single slides) FX x 05 (single slides)

155 Further Reagents for EUROIMMUN IIFT Reagent Format ZF sample buffer (IIFT) 4.5 ml ZF salt for PBS, ph pack 2.50 (to be dissolved in 1 liter of distilled water) ZF Tween ml 0.50 ZF (2.0 ml to be added to 1 liter of PBS) 20 ml 4.00 ZF additive (exclusively) for CMV buffer 1 ml 0.50 (1.0 ml as admixture for 1.0 liter PBS) ZF distilled water for PBS 1.0 l 5.00 (only to be used with EUROIMMUN test systems) ZF urea solution 5 M, 1.0 ml 2.50 ZF (for the determination of low-avide antibodies 6 M, 1.0 ml 2.50 ZF in infectious serology) 8 M, 1.0 ml 2.50 ZF glycine urea buffer 1.5 ml 2.50 ZF Evans Blue 1.5 ml % in PBS ZF embedding medium 3.0 ml 2.50 ZF (containing anti-bleaching reagent) 20 ml ZF ml ZF ml ZF EUROSORB for immunofluorescence 4.5 ml (liquid RF absorbent) ZF sorbent for FTA-ABS test for 1.0 ml ZF (lyophilized) for 5.0 ml ZF human serum, frozen, lyophilisate for 0.05 ml 2.50 ZF as complement source lyophilisate für 0.15 ml 5.00 ZF lyophilized, lyophilisate für 0.25 ml EBV antibody negative Other Items for EUROIMMUN IIFT Item Format ZZ cover glasses 12 pieces 4.00 ZZ (embedding slides with 22 pieces or 10 fields) ZZ cover glasses 12 pieces (for embedding slides with 50 fields) ZZ incubated slide for 1 piece demonstration purposes ZZ slide tablet for 10 slides 3.50 ZZ for storage of incubated slides with up to 10 fields for 20 slides 5.00 ZZ slide tablet for 2 slides 3.50 ZZ for storage of incubated slides with 50 fields for 4 slides 5.00 ZZ reagent tray for for slides with 5 fields ZZ the incubation of slides for slides with 10 fields ZZ for slides with 96 fields ZZ reagent tray for the for slides with 50 fields incubation of slides with 1 BIOCHIP per field Further Reagents ZZ reagent tray for the for slides with 50 fields incubation of slides with 2 to 4 BIOCHIPs per field 155

156 General Delivery Conditions Products from EUROIMMUN will be delivered according to the following conditions, as long as no other conditions have been agreed in writing. On issuing an order, the buyer acknowledges the delivery conditions. EUROIMMUN does not accept the sales conditions of the buyer, even when EUROIMMUN has not expressly contradicted them. Contract terms are valid for all future business connection even if they have not been expressly agreed upon again. Orders: Orders to EUROIMMUN can be made in writing (including electronic communication) or verbally. Verbally issued orders first become legally binding for EUROIMMUN with a written confirmation from the orderer or with the delivery of goods. Delivery: EUROIMMUN generally delivers to end users within 7 days of order receipt and to distributors within 14 days, but is not tied to any definite delivery period. If a delivery is not possible through unforseeable circumstances (e.g., factory disruptions, raw material delivery delays, transport difficulties, strikes), the delivery obligation does not apply. EUROIMMUN reserves the right to deliver in part. The delivery obligation of EUROIMMUN ceases as long as the customer is in arrears. EUROIMMUN chooses the packing and dispatching method at its own discretion, according to the respective requirements. Product characteristics: The delivered products comply with specifications given in the product catalogue, on the product itself, or in the supplied information sheets. If specifications are inconsistent, the labels on the product itself and the details in the information sheet provided with the product apply. After the given expiration date has passed, the test reagents must not be used. EUROIMMUN products must only be used for the intended purpose. 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157 Index Autoantibody Diagnostics acetylcholine receptor (ACHR)... 12, 17, 84 Actin , 32, 38, 45, 64, 125, 132 adrenal cortex... 13, 17, 43, 62, 120 AMA. 6, 13, 16-17, 26, 32-34, 37-40, 43, 45, 64, 72, 74-75, 82-83, 120, , ANA... 14, 16-17, 26, 32-35, 37-38, 41, 44-45, 64, 76, 82, , ANCA , 16-17, 32, 44-45, 62-63, 81, , ASCA... 15, 17-18, 71, 87, 95, 124, 150 ASMA... 12, 16-17, 38, 64, 125, Autoantibody Profile Automated solutions... 4, 8, 22, 26, 28, 33, 39, 41, 49, 51-53, 58, basement membranes... 12, 14, 16-17, 63, 76, 81, 128 ß2-glycoprotein bile ducts... 17, 32 BPI... 17, 44-45, 81 brain... 12, 17, 62, C1q... 16, 81, 83 canca... 12, 16-17, 32, 44-45, 62, 81, , cardiolipin (AMA M1) , 79, cartilage... 16, 128 cathepsin G... 17, 44-45, 81 cell nuclei (ANA global test) , 129 centromere... 14, 16, 32, 34, 45, 64, 82 cerebellum , 41-42, 78, circulating immune complexes (CIC)... 16, 83 cyclic citrullinated peptide (CCP)... 16, 36, 81 Cyclin I (PCNA)... 12, 16, 26, 32-33, 45, 64, 76, 82 Cyclin II (Mitosin)... 12, 45, 64 cytoplasm of granulocytes , 16-17, 44-45, 62-63, 80, , 124 desmosomes... 12, 17, 63, 128 dsdna... 6, 12, 16-17, 26, 32-35, 38, 41, 45, 64, 74-75, 81-82, 84, elastase... 17, 44-45, 81 elastin... 12, 16-17, 65 ENA... 16, 24, 32, 34, 75-76, 82 endomysium... 12, 17, 32, 46, 65, 83, endothelial cells , 16-17,, 32, 62, 65, 136 epidermis , 17, 36, 63, 128 EUROIMMUN Analyzer I... 22, 155 EUROLineScan... 4, 26, 28, 33, 39, 41, 49, 51-53, 58, 155 EUROPLUS. 3, 7, 32, 37-38, 40, 44, 46, 48, 120, , , , , 144 EUROStar... 8, eye antigens F-actin... 17, 38, 64, 125, 132 GAD... 12, 17, 41-42, 62, 81, 84, 120 Gangliosides... 17, 76 gliadin... 12, 17, 46, 65, 72, 89, 98, , 154 glomerular basement membrane (GBM)... 12, 17, 63, 76, 81, glutamat-decarboxylase... 12, 17, 41-42, 62, 81, 84 Golgi apparatus... 12, 16, 32, 45, 64 Goblet cells... 12, 17, 63, , 130 heart muscle... 12, 17, 38, 125, 130 HEp-2-cells... 6, 12-14, 32-33, 35, 37-38, 44-45, 78, , histones... 6, 12, 16, 26, 32-34, 45, 75-76, Hu... 12, 17, 41, 62, 76, 78, HUVEC hypothalamus antigens... 12, 17, 121 IA , 42, 81, 84 Insulin... 17, 42, 84, 91 intestinal goblet cells... 12, 17, 63, intrinsic factor... 13, 17, 43, 63, 81, 126 Jo , 16, 24, 26, 32-34, 45, 64, 75-76, 78, 82-83, keratin... 13, 16-17, 36, 63, 128 Ku... 13, 16, 33, 45, 64, 76, 78 lactoferrin... 17, 44-45, 81 LC , 32, 38-39, 75-76, 81, 125 Leydig cells... 17, 43, 62, liver-kidney microsomes (LKM)... 13, 17, 32, 37-39, 63, 75-76, 81, 125 liver-specific antigens... 6, 13, 16-17, 26, 32-34, 37-39, 64, 75-76, 81-83, 125 LKM , 17, 32, 37, 39, 75-76, 81, 125 lung alveoli... 17, 125 lymphocyte antigens... 13, 17, 124 M2 ag (AMA-M2)... 6, 16-17, 19, 26, 33-34, 37-39, 64, 72, 75-76, 82-83, 125, M4 antigen... 13, 17, 32, 37, 75 M9 antigen... 13, 17, 32, 37, 64, 75 Mab... 17, 40, 62, 120 M... 13, 17, 41, 62 Mi , 16, 33, 45, 76, 78 mitochondria (AMA) 6, 13, 26, 32, 34, 37-40, 43, 45, 64, 72, 75-76, 82-83, 120, mitosin... 12, 45, 64 myelin , 17, 41, 62 myeloperoxidase (MPO)... 13, 17, 44-45, 63, 75-76, 81, 124 ndns... 6, 12, 16-17, 26, 32-35, 38, 41, 45, 64, 75-76, 81-82, 84, nerves , 17, 41, 62, neuronal autoantibodies... 12, 14, 17, 41, 62, 76, 78, nrnp/sm... 16, 24, 26, 32-34, 45, 74-75, 82, nuclear membrane... 17, 32, 45, 64 nucleosomes... 16, 32-35, 45, 75-76, oesophagus , 36, 46, 128, ovarial antigens... 43, 120 P/Q calcium channel (VGCC)... 17, 82 panca... 13, 16-17, 32, 44-45, 63, 81, , pancreas islets... 12, 42-43, 63, 81, , parathyroid gland... 13, 17, 120 parietal cells (PCA)... 12, 43, 63, 81, 120, parotid gland excretory ducts and acini , 17, 63, 127 PCNA (Cyclin I)... 12, 16, 26, 32-33, 45, 64, 76, 82 phosphatidylserine , 81 phospholipids , 79, pituitary gland antigens... 12, 17, 121 PL , 33, 45, 76, 78 PL , 33, 45, 76, 78 placenta... 14, 17, 62, 121 PM-Scl... 6, 16, 26, 32-34, 45, 75-76, 78, 82 proteinase 3 (capture test)... 44, 81 proteinase 3 (PR3)... 14, 17, 44-45, 75-76, 81, 124 renal glomeruli (GBM)... 12, 17, 63, 76, 81, reticulin... 14, 17, retina , 17, 122 rheumatoid factors... 36, 56 Ri... 14, 17, 41, 62, 76, 78, RIA... 30, 35, 40, 42, ribosomal P-proteins... 14, 16, 32, 64, 82 RNS-Polymerase... 14, 16, 32, 45 Ro , 26, 32-34, 39, 45, 75-76, 78, 82 saccharomyces cerevisiae... 15, 17-18, 72, 89, 97, , 154 Scl , 16, 24, 26, 32-34, 45, 64, 75-76, 82, skeletal muscle , 17, 38, 125, 127, 130 SLA/LP... 17, 32, 38-39, 72, 75-76, 81, 125 Sm... 14, 16, 24, 26, 32-34, 45, 64, 75-76, 82, smooth muscles... 12, 16-17, 38, 64, 125, Sp , 38-39, 64, 76, 125 spermatozoa... 14, 17, 62, 121 spindle fibers... 16, 32, 45, 64 SS-A... 6, 14, 16-17, 24, 26, 32-34, 45, 64, 75-76, 78, 82, SS-B... 6, 14, 16-17, 24, 26, 32-34, 45, 64, 75-76, 82, ssdna... 14, 16-17, 34, 45, TAb... 17, 40, 62, 120 testis... 14, 17, 40, 43, 62, thrombocyte antigens... 14, 17, 63, 124 thyroglobulin (TG)... 14, 17, 40, 43, 62, 75, 81, 84, 120 thyroid gland , 17, 40, 43, 62, 75, 81, 84, 120 thyroid peroxidase (TPO)... 40, 75, 81, 84 TRAb... 17, 40, 81, 84 transglutaminase... 17, 46, 83 U1-nRNP... 14, 16, 64, 82 vascular endothelium Vimentin... 14, 16, 32, 45, 64 Yo... 14, 17, 41, 62, 76, 78, Infectious serology Adenovirus... 15, 18, 54-55, 71, 88, 148 Afipia felis... 15, 18, 67 Automated solutions... 4, 8, 22, 26, 28, 33, 39, 41, 49, 51-53, 58, Bartonella... 15, 18, 54, 67-68, 142 Bordetella... 15, 18, 54, 66, 137 Borrelia , 21, 28, 48-49, 54-55, 66-67, 73, 79, 85, Brucella abortus Campylobacter... 15, 18, 55, 66, 137 Candida... 15, 18, 54-55, 72, 109, Chlamydia , 18, 54-55, 67, 86, Coxsackie virus... 15, 18, 54-55, 71, Cytomegalovirus (CMV)... 15, 18, 21, 54-55, 69, 77, 80, 87, , 157 Dengue virus... 15, 70, 88, 147, 153 EBNA... 15, 18, 50-51, 77, 89, EBV-CA... 7, 15, 18, 21, 50-51, 54-55, 71-72, 88-89, EBV-EA... 7, 15, 18, 50, 54-55, 72, 89, Echinococcus granulosus... 15, 18, 55, 68, 79, 86, 112, 144 Echo virus... 15, 18, 54-55, 71, 150 Epstein-Barr virus capsid ag... 7, 15, 18, 21, 50-51, 54-55, 71-72, 77, 88-89, EUROIMMUN Analyzer I... 22, 155 EUROLineScan... 4, 26, 28, 33, 39, 41, 49, 51-53, 58, 155 EUROPLUS. 3, 7, 32, 37-38, 40, 44, 46, 48, 120, , , , , 144 EUROSORB IgG/RF-Absorbens... 56, 60, 157 EUROStar... 8, Haemophilus influenzae... 15, 18, 54, 66, 137 Helicobacter pylori... 15, 18, 52, 55, 65, 73, 79, 85, 137 Herpes simplex (HSV)... 15, 17-18, 53-55, 69, 74, 80, 86-87, 145 HHV , 18, 54, 69, 144 HIV... 15, 18, 54-55, 68-69, 144 Influenza virus... 15, 18, 54-55, 66, 71, 88, 137, Klebsiella pneumoniae... 15, 18, 54-55, 66, 137 Legionella... 15, 18, 54, 67, 85, Leishmania... 15, 18, 68, 143 Listeria... 15, 18, 54, 67, Measles virus... 15, 18, 21, 54-55, 60, 68, 87, 146 Mumps virus... 15, 18, 21, 54-55, 66, 87, 146 Mycoplasma... 15, 18, 54-55, 68, 86, 143 Parainfluenza virus... 15, 18, 54-55, 71, 88, 149 Plasmodium... 77, 144, 153 Reiter spirochetes Respiratory syncytial virus (RSV)... 15, 18, 54, 70, 88, 147 Rubella virus... 7, 15, 18, 21, 54-55, 69, 77, 87, SARS coronavirus... 69, 87, 146 TBE virus... 15, 18, 21, 48-49, 70, 87-88, Toxoplasma gondii... 7, 15, 18, 21, 54-55, 68, 77, 86, 144 Treponema pallidum... 15, 18, 54, 66, 73, 79, 85 Ureaplasma urealyticum... 15, 18, 68, 143 Varicella zoster virus (VZV)... 15, 18, 21, 54-55, 70, 87, 146 VlsE... 15, 28, 48-49, 67, 79, 85, West-Nile virus... 7, 15, 21, 70, 88, Yersinia enterocolitica , 18, 55, 67, 73-74, 79, 85, 141 Allergology animal allergens... 19, automated solutions... 4, 8, 22, 26, 28, 33, 39, 41, 49, 51-53, 58, environmental allergens... 19, EUROIMMUN Analyzer I... 22, 155 EUROLineScan... 4, 26, 28, 33, 39, 41, 49, 51-53, 58, 155 food... 19, 58, 76-78, further allergens grasses... 19, 58, herbal and flower pollen... 19, 58, 99, house dust... 19, 108 insects... 19, 58, 78, mites... 19, 58, 93, 108 moulds... 19, parasites , 112 pharmaceutical drugs... 19, trees... 19,

158 Primate pancreas: Autoantibodies against islet cells in diabetes mellitus. D Luebeck (Germany) Seekamp 31 Telephone: Fax: