EURO DIAGNOSTICA PRODUCT CATALOG

Transcription

1 EURO DIAGNOSTICA PRODUCT CATALOG

2 Copyright: 2012, Euro Diagnostica AB Version: Graphic design: Oddville AB Printed by: Bildcenter i Lund AB

3 Introduction Welcome to Euro Diagnostica We are proud to introduce the 2012/2013 Euro Diagnostica Product Catalog Today, Euro Diagnostica is an international diagnostic solutions provider in autoimmunity testing with a long history and commitment to quality. The company celebrates 20 years this year and was created following a merger between Ferring Diagnostica, Balticor Diagnostica, Euro Diagnostics and Medscand Diagnostics (MILAB). In 2004, Euro Diagnostica expanded its services by acquiring Wieslab AB, Sweden, a leading autoimmunity testing laboratory. From its facilities in Malmö, Sweden, Euro Diagnostica develops, manufactures and markets an extensive product range of the highest possible quality in over 100 countries. Our complete diagnostic kits and reagents are used daily in medical assessments both manually and on the majority of instrument platforms available worldwide. Our tests are developed for clinical auto immunology, microbiology and immunochemistry. Thanks to the long experience and continuous development of our personnel and production processes, Euro Diagnostica offers top quality cost-effective customized coating services. Our Laboratory Testing Unit, Wieslab, offers clinical testing and disease assessment within autoimmunity by qualified diagnostic specialists every day of the year. Wieslab Laboratory Services offers a comprehensive range of individual and panel tests, and ensures accurate and fast results. Testing is available for most autoimmune diseases. Comprehensive Product Portfolio As you will see, we offer test systems for diagnostics and treatment-associated monitoring in the following major focus areas: Early diagnosis of rheumatoid arthritis the anti-ccp 2 assay is one of the main focus products for our company Serological detection of autoimmune vasculitis we offer the most complete product range for ANCA testing Complement deficiency diagnosis our Complement product line provides a unique functional assessment of the Complement system Neuro-endocrine tumors diagnosis Chromogranin A is available both as radioimmunoassay and ELISA. Our ELISA tests are harmonised for use on Dynex instruments Our Mission - improving patient care Our aim is to constantly improve and expand our offering to contribute to better patient care. To achieve this, we have made a clear shift in emphasis. Euro Diagnostica now has a clear focus on diagnosis, prognosis and theranostics of autoimmune and related diseases. We have a global approach and strategy, are expanding our current business plus our collaboration with research partners, and are building a worldwide sales and distribution network. By having the laboratory services as an integrated unit of our company, we know and understand the challenges laboratories and clinicians face every day in the autoimmunity testing. To help solve these challenges, we continuously validate innovative tests at Wieslab Laboratory Services to develop and bring new solutions for you and for patients. product catalog I 3

4 INTRODUCTION Introduction Welcome to Euro Diagnostica Quality is our main value Quality is a key element at Euro Diagnostica, codified in a quality system that has EN ISO 13485:2003 certification (Sweden). Euro Diagnostica does not regard these standards as a maximum to be achieved, but as a basis for the further improvement of our expertise and know-how. The advanced and extensive range of diagnostic products is the most tangible confirmation of our quality. Furthermore, we ensure that our buyers receive excellent customer service and technical support. We combine our expertise with great commitment in solving the practical issues confronting our clients. Our aim is to constantly develop solutions to aid clinicians in the diagnosis, prognosis, monitoring and treatment of autoimmune and related diseases. With so much at stake, our focus is on helping you to get the correct diagnosis to the patient every time. Euro Diagnostica s sights are set firmly on being part of the personalised medicine development. We thank you for your interest in our products and we commit ourselves to continually developing and providing you with the highest quality innovative clinical solutions. Welcome to Euro Diagnostica! In this edition, you will find short descriptions of all of our products. For a more comprehensive overview of our company, products and services, please visit us at our website: Visit our website 4 I product catalog

5 Euro Diagnostica ANSWERS TO YOU product catalog I 5

6 TABLE OF CONTENTS Product Catalog Table of contents Rheumatoid Arthritis About Rheumatoid Arthritis 09 CCPlus Immunoscan 10 Anti-CCP EDIA 11 CCPoint 12 CCPoint US 13 hcomp quantitative kit Wieslab 14 sgag quantitative kit Wieslab 15 Vasculitis About Vasculitis 17 PR3 ANCA Wieslab /DIASTAT 18 Capture PR3-ANCA Wieslab 18 MPO ANCA Wieslab /DIASTAT 19 Capture MPO-ANCA Wieslab 19 Anti-GMB, ANCA screen kit Wieslab 20 ANCA panel kit Wieslab 20 Goodpasture s syndrome About Goodpasture s syndrome 22 Anti-GBM semi quantitative kit Wieslab 23 Complement About Complement 25 Complement system Screen Wieslab 26 Complement system AP Wieslab 27 Complement system CP Wieslab 27 Complement system MBL Wieslab 28 Complement system Ficolin 3 Wieslab 28 Connective tissue disorders About Connective tissue disorder 29 ANA DIASTAT 30 Anti-Centromere DIASTAT 31 Anti-La (SS-B) DIASTAT 31 Anti-dsDNA DIASTAT 32 Anti-Jo-1 DIASTAT 33 Anti-Mitochondria DIASTAT 33 Anti-Scl-70 DIASTAT 33 Anti-Ro (SS-A) DIASTAT 34 Anti-Sm DIASTAT 34 Anti-Sm/RNP DIASTAT 35 ENA single well screen DIASTAT 35 ENA profile DIASTAT 35 Congenital heart block About Congenital heart block 36 Anti-SS-A p200 Wieslab 37 Anti-phospholipid syndrome About Antiphospholipid syndrome 39 Anti-beta-2-glycoprotein 1 IgG DIASTAT 40 Anti-beta-2-glycoprotein 1 IgM DIASTAT 40 Anti-Cardiolipin IgG DIASTAT 41 Anti-Cardiolipin IgM DIASTAT 41 Anti-Cardiolipin Total DIASTAT 41 Visit our website 6 I product catalog

7 Autoimmune Gastroenterology About Autoimmune Gastroenterology 42 ASCA IgA Wieslab 43 ASCA IgG Wieslab 43 Thyroid diagnostics About Thyroid diagnostics 44 Anti-Tg DIASTAT 45 Anti-TPO DIASTAT 45 Endocrine markers About Endocrine markers 46 Angiotensin II EURIA 47 ANP EURIA 47 CCK EURIA 48 Chromogranin A NeoLisa 48 Chromogranin A and B EURIA 49 Beta-Endorphin EURIA 50 Endothelin EURIA 50 Gastrin EURIA 51 Glucagon EURIA 51 Alpha-MSH EURIA 52 NPY EURIA 52 PP EURIA 53 Somatostatin EURIA 53 Vasopressin EURIA 54 VIP EURIA 54 Pertussis About Pertussis 55 Pertusscan TRO 56 Pertusscan PT IgG 56 Instrumentation 58 Wieslab Laboratory Services 60 Product Overview 62 Product List 68 Ordering Information 70 product catalog I 7

8 THE PAST THE PRESENT THE FUTURE Immunoscan CCPlus Ultimate Anti-CCP ELISA for the serological diagnosis of Rheumatoid Arthritis The CCP2 test is recognized as the gold standard of testing for anti-ccp CCPoint Unique CCP2 rapid test Only 10 minutes to result Visit our website 8 I product catalog

9 Rheumatoid arthritis Disease information Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic inflammation of the synovial joints The inflammation leads to joint swelling, progressive joint erosion and ultimately to cartilage and bone destruction. The disease is often disabling and significantly affects quality of life. Rheumatoid arthritis is prevalent in all ethnic groups, affecting approximately % of the population of the western world. As is often the case with autoimmune diseases, there is a female over-representation. Onset is most frequent between the ages of 40 and 50, but people of any age can be affected. There is clearly a genetic disposition to the disease suggested by the fact that individuals with the HLA-DR1 or HLA-DR4 serotypes have an increased risk for developing RA. Symptoms The clinical picture of RA involves signs of inflammation, with the affected joints being swollen, warm, painful and stiff, particularly early in the morning on waking or following prolonged inactivity. The swelling of the joint is caused by the excessive production of joint fluid (synovial fluid) as part of the inflammation process (synovitis). While rheumatoid arthritis primarily affects joints, problems involving other organs of the body are known to occur. Extra-articular manifestations are clinically evident in about 15 25% of individuals with rheumatoid arthritis. The rheumatoid nodule, which is sometimes cutaneous, is the feature most characteristic of rheumatoid arthritis. This is a type of inflammatory reaction known to pathologists as a necrotizing granuloma. Fibrosis of the lungs is a recognized extra-articular manifestation of rheumatoid disease. The lung tissue itself can also become inflamed, scarred, and sometimes inflammatory nodules (rheumatoid nodules) develop within the lungs. Inflammation of the pericardium surrounding the heart, called pericarditis, can cause a chest pain. People with rheumatoid arthritis are more prone to atherosclerosis, and risk of myocardial infarction (heart attack) and stroke is markedly increased. Disease outcome may vary from mild clinical symptoms to severe systemic disease when joint destruction is accompanied by these extra-articular manifestations. Diagnosis So far, no therapy has been developed that cures the disease. Current therapies may, however, slow down the extent of swelling and erosive damage. To achieve the greatest therapeutic potential and effect it is essential to initiate treatment at an early stage of the disease. Early and accurate diagnosis is therefore of outmost importance and the presence of autoantibodies to citrullinated proteins/peptide (anti-ccp) has an important prognostic value for the disease. These antibodies can be detected even before the onset of clinical symptoms. The anti-ccp2 test has a very high specificity and sensitivity and is a reliable and accurate toolset for the early diagnosis and follow-up of RA. Due to its wide clinical use, anti-ccp is included in the ACR/EULAR criteria for diagnosing RA. The Rheumatoid Arthritis Classification Criteria, jointly published by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) established a point value between 0 and 10. Every patient with a point total of 6 or higher is unequivocally classified as an RA patient. Of these six points, three may be acquired by presence of anti-ccp2 autoantibodies. Code Name Description Page RA-96PLUS 1 CCPlus Immunoscan ELISA 10 FCCP Anti-CCP EDIA ELISA 11 CCPoint 20 2 CCPoint Lateral flow/rapid test 12 CCPoint 20 US 1 CCPoint US Lateral flow/rapid test 13 COMP hcomp quantitative kit Wieslab ELISA 14 GAG sgag quantitative kit Wieslab Dye binding assay 15 1) Please contact your local representative for availability in your country, available in US! 2) Please contact your local representative for availability in your country, not available in US! 3) For research use only, contact your local representative for research use availability in your country. product catalog I 9

10 RHEUMATOID ARTHRITIS Rheumatoid arthritis Products CCPlus Immunoscan The Immunoscan CCPlus assay is based on highly purified synthetic peptides containing citrulline residues selected on the basis of their superior performance in detecting Rheumatoid arthritis RA autoantibodies. Euro Diagnostica anti-ccp testing and the anti-ccp2 test is recognized as the gold standard of testing for anti-ccp. The majority of anti-ccp2 in the world are supplied by Euro Diagnostica. Intended use Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals. For in vitro diagnostic use. Background Since the first report in 1998 that antibodies reacting with synthetic peptides containing the amino acid citrulline are highly specific for RA, the measurement of anti-ccp antibodies has become the method of choice in the accurate diagnosis of this disease. The anti-ccp2 assay is as sensitive as the rheumatoid factor test but with much higher specificity. Anti- CCP antibodies have a high positive predictive value and can be detected years before the development of clinical symptoms. A diagnostic value for the measurement of anti-ccp antibodies has been found in relation to joint involvement and radiological damage in early RA. The presence of anti-citrullinated protein antibodies is now one of the ACR-criteria for classification of RA as well as part of EULAR s recommendations. Sensitivity at stratified specificity (98.5%) for available RA diagnostic markers (100 RA patients and 102 healthy controls) Immunoscan CCPlus 73 CCP3 67 MCV 62 RF 17 Ref: Bizzaro N, Tonutti E, Tozzoli R, Villalta D.Clin Chem Aug;53(8): Epub 2007 Jun 22 RA-96PLUS 1 CCPlus Immunoscan 96 wells (12x8 microtitre strips) 1) Please contact your local representative for availability in your country, available in US! Visit our website 10 I product catalog

11 Anti-CCP EDIA Antibodies against cyclic citrullinated peptide (anti-ccp) are highly specific for rheumatoid arthritis (RA), one of the most common systemic autoimmune diseases affecting up to 0.4-1% of the world population. Euro Diagnostica, in collaboration with world-leading scientists, invented anti-ccp testing and the anti-ccp2 test is recognized as the gold standard of testing for anti-ccp. Today, Euro Diagnostica manufactures and supplies the majority of anti-ccp2 in the world. The presence of anti-citrullinated protein antibodies is now one of the ACR-criteria for classification of RA. The EDIA TM anti-ccp kit contains improved synthetic peptides selected on the basis of their superior performance in the detection of RA autoantibodies. Intended use EDIA anti-ccp test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. The assay is used to detect antibodies in a single specimen. Assay results are used to aid the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals. For in vitro diagnostic use. Background Rheumatoid Arthritis (RA) is one of the most common systemic autoimmune diseases. FCCP Anti-CCP EDIA ELISA (96 wells) 1) Please contact your local representative for availability in your country, available in US! The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis Target population (Who should be tested?): Patients who 1) have at least 1 joint with definite clinical synovitis (swelling) 2) with the synovitis not better explained by another disease Classification criteria for RA (score-based algorithm: add score of categories A-D; a score of 6/10 is needed for classification of a patient as having definite RA). A. Joint involvement Score 1 large joint large joints small joints (with or without involvement of large joints) 4 10 small joints (with or without involvement of large joints) >10 joints (at least 1 small joint) 5 B. Serology Score Negative RF and negative ACPA 0 Low-positive RF or low-positive ACPA 2 High-positive RF or high-positive ACPA 3 C. Acute-phase reactants Score Normal CRP and normal ESR 0 Abnormal CRP or abnormal ESR 1 D. Duration of symptoms Score 2 3 <6 weeks 0 6 weeks 1 Reference: Arthritis & Rheumatism Vol 62(9), pages , September 2010 product catalog I 11

12 RHEMATOID ARTHRITIS Rheumatoid arthritis Products CCPoint The first RAPID test for anti-ccp that enables fast, near-patient diagnosis, thus making quick treatment start possible. Percent agreement of the CCPoint assay compared to alternative anti-ccp ELISA Intended use Euro Diagnostica CCPoint test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human capillary whole blood, plasma or serum. Test results are used to aid the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by healthcare professionals. For in vitro diagnostic use. CCPoint Alternative ELISA Positive Negative Total Positive Negative Total Background CCPoint test is a colloidal gold-based lateral flow immunoassay. Reactive cyclic citrullinated peptides are immobilised as a discrete line on a porous membrane located in the test zone. The detection reagent, consisting of colloidal gold particles conjugated to anti-human IgG, is deposited within the device onto the conjugate pad. In the assay procedure, a sample of blood is added to the sample port. A blood cell separation membrane transfers the sample fluid onto the porous membrane. After short incubation, running buffer is added to the buffer port. This buffer mobilizes the colloidal gold particles from the conjugate pad. The gold particles and the sample move by capillary force across the membrane. If the sample contains anti-ccp antibodies, they will bind to the peptide-antigens and a red line will appear in the test zone (marked T). If the sample does not contain anti-ccp antibodies, no line will appear. With any sample, a red control line should appear in the control zone (marked C). The control ensures that the coated colloidal gold is still active. Kit components (Contents of CCPoint 20) 20 Foil pouches containing the CCPoint test device 22 Disposable pipettes (20 µl) 2 Droplet bottles, each containing 3 ml of running buffer 1 CCPoint Instructions for Use 1 Quick Reference Instruction CCPoint 20 2 CCPoint Lateral flow/rapid test 2) Please contact your local representative for availability in your country, not available in US! Visit our website 12 I product catalog

13 CCPoint US The first anti-ccp test that enables rapid diagnosis, which makes an early initiation of treatment possible. Percent agreement of the CCPoint assay compared to alternative anti-ccp ELISA Intended use EuroDiagnostica CCPoint test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. Test results are used to aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by trained laboratory professionals. For in vitro diagnostic use. CCPoint US Alternative ELISA Positive Negative Total Positive Negative Total Background CCPoint test is a colloidal gold-based lateral flow immunoassay. Reactive cyclic citrullinated peptides are immobilised as a discrete line on a porous membrane located in the test zone. The detection reagent, consisting of colloidal gold particles conjugated to anti-human IgG, is deposited within the device onto the conjugate pad. In the assay procedure, a sample of serum or plasma is added to the sample port. A blood cell separation membrane transfers the sample fluid onto the porous membrane. After a short incubation, running buffer is added to the buffer port. This buffer mobilizes the colloidal gold particles from the conjugate pad. The gold particles and the sample move by capillary force across the membrane. If the sample contains anti-ccp antibodies, they will bind to the peptide-antigens and a red line will appear in the test zone (marked T). If the sample does not contain anti-ccp antibodies, no line will appear. With any sample, a red control line should appear in the control zone (marked C). The control ensures that the coated colloidal gold is still active. Kit components (Contents of CCPoint US 20) 20 Foil pouches containing the CCPoint test device 2 Droplet bottles, each containing 3 ml of running buffer 1 CCPoint Instructions for Use CCPoint 20 US 1 CCPoint US Lateral flow/rapid test 1) Please contact your local representative for availability in your country, available in US! product catalog I 13

14 RHEMATOID ARTHRITIS Rheumatoid arthritis Products hcomp quantitative kit Wieslab Serum levels of COMP can provide important information about metabolic changes occurring in the cartilage matrix in joint disease. Serum COMP levels have been shown to correlate with cartilage degradation and are thus a potential prognostic marker in inflammatory joint diseases such as osteoarthritis (OA) and rheumatoid arthritis (RA). Intended use Wieslab hcomp is an enzyme immunoassay for quantitation of intact or fragmented human Cartilage Oligomeric Matrix Protein (COMP) in serum or synovial fluid. The assay serves as an indicator of cartilage turnover. The analysis should be performed by trained laboratory professionals. For research use only. Background COMP is the major non-collagenous protein in cartilage. It is important for the formatation and stability of cartilage. Measurement of intact COMP and fragments thereof in synovial fluid or serum has been shown to correlate with cartilage destruction in rheumatoid arthritis and osteoarthritis patient studies. In synovial fluid, COMP is present to some extent as an apparently intact protein but the majority is found as several different fragments, as in serum. COMP hcomp quantitative kit Wieslab 96 wells 3) For research use only, contact your local representative for research use availability in your country. Visit our website 14 I product catalog

15 sgag quantitative kit Wieslab The Alcian Blue reagent in Wieslab s sgag assay has been carefully selected and optimised for proteoglycan assays. The most abundant heteropolysaccharides in the body are the glycosaminoglycans (GAGs). They are located primarily on the surface of cells or in the extracellular matrix. As an example, cartilage is composed to a large extent of GAGs, which are the dominant part of the proteo - glycan Aggrecan. COOH O H H 4 1 OH H H H OH O HO S O O β O H CH 2 OH O O 3 H H H NHCOCH 3 GAGs are negatively-charged long unbranched polymeric polysaccharides composed of repeating units of disaccharides containing one uronic acid or galactose and one amino sugar, either N-acetyl-glucosamine or N-acetylgalactosamine. The variation in charge may be very large since each disaccharide is more or less sulphated. Based on GAG s high negative charge, a number of dye-binding procedures for their measurement have been developed. In most cases, how ever, these are not applicable to biological material without different forms of pre-treatment such as protease digestion. The present assay makes use of the dye Alcian blue, which has a long history as a histological tissue staining reagent. Alcian blue is a tetravalent cation with a hydrophobic core. The four charges allow the dye to bind to negativelycharged polymers such as GAGs at high ionic strength, in contrast to other cationic dyes which are all monovalent. The molecular structure of Alcian blue, i.e. the plane tetragonal hydrophobic core with positive charges at its corners, may facilitate formation of aggregates of several molecules side-by-side rather than micelle formation. The ionic strength, ph and presence of detergents will affect the size of these aggregates in solution. GAG sgag quantitative kit Wieslab 200 3) For research use only, contact your local representative for research use availability in your country. product catalog I 15

16 ULTIMATE SEROLOGICAL TOOL FOR VASCULITIS DIAGNOSIS Wieslab Capture ANCA Higher clinical sensitivity and clinically proven prognostic performance Visit our website 16 I product catalog

17 Vasculitis Disease information Vasculitis is a general term referring to a heterogeneous group of diseases that are characterised by inflammatory destruction of blood vessels The inflammation cause changes in the vessel wall, which can lead to serious complications damaging the body s organs. The cause of many forms of vasculitis is not understood. Often there is a presence of autoantibodies that are sometimes used in classification, as in ANCAassociated vasculitides (Anti-neutrophil cytoplasmic antibodies). Examples of ANCA-associated vasculitides are granulomatosis with polyangiitis (GPA) (previously named Wegener s granulomatosis), microscopic polyangiitis (MPA), and Churg-Strauss syndrome. GPA is a vasculitis that affects the nose, lungs, kidneys and other organs. The incidence of GPA is about 10 cases per million per year. It is a life-threatening disease and requires life-long immunosuppression. Initial signs are extremely variable, and diagnosis can be delayed due to the vague nature of the symptoms. Often the kidneys and lungs are affected and their functions impaired. A serious complication of GPA is rapidly progressive glomerulonephritis (RPGN). Microscopic polyangiitis (MPA) is characterized by small vessel vasculitis without evidence of granulomatous inflammation. The annual incidence in the US of MPA is 3.6 cases per million persons. MPA and GPA comprise a category of small vessel vasculitis related to the presence of ANCAs. MPA and GPA seem to be part of a clinical spectrum and share a number of clinical symptoms. However, the absence of granuloma formation and sparing of the upper respiratory tract are features of MPA that help to distinguish it from GPA. Occasionally, however, the two conditions are difficult to distinguish. Churg-Strauss syndrome mainly involves the small to medium blood vessels of the lungs but eventually also affects the gastrointestinal tract, heart, skin and kidneys. It may also affect the peripheral nerves. Churg-Strauss syndrome is often referred to as allergic granulomatosis due to its clinical course often starting as a severe form of asthma. Code Name Description Page Cap PR3 IU 2 Wieslab Capture PR3-ANCA PR3 ANCA (Capture) 18 PR3 IU 2 Wieslab PR3-ANCA PR3 ANCA 18 FPRO DIASTAT PR3-ANCA PR3 ANCA 18 Cap MPO IU 2 Wieslab Capture MPO-ANCA MPO ANCA (Capture) 19 MPO IU 2 Wieslab MPO-ANCA MPO ANCA 19 FMPO DIASTAT MPO-ANCA MPO ANCA 19 GCP Anti-GBM, ANCA screen kit Wieslab GBM + MPO ANCA + PR3 ANCA 20 PAN ANCA panel kit Wieslab Azurocidin,BPI, Cathepsin G, Elastase, Lactoferrin, Lysozyme ANCA CP Wieslab ANCA screen kit MPO ANCA + PR3 ANCA 20 GCP-CAP 2 Vasculitis screen Wieslab GBM + MPO ANCA (Capture)+ PR3 ANCA Capture GP 104X 1 Wieslab Anti-GBM, semi quantitative kit GBM 23 FGBM DIASTAT Anti-GBM, ANCA screen kit GBM ) Please contact your local representative for availability in your country, available in US! 2) Please contact your local representative for availability in your country, not available in US! product catalog I 17

18 VASCULITIS Vasculitis Products PR3-ANCA Capture PR3-ANCA Wieslab Wieslab Capture PR3-ANCA test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and quantitation of IgG antibodies to proteinase 3 (PR3) in human sera. The assay is used to detect antibodies in a single serum specimen. Assay results are used to aid the diagnosis of granulomatosis with polyangiitis. Wieslab Capture PR3-ANCA is standardized against the AF-CDC standard, code IS2721 (Human Reference Serum 16). Overview ANCAs (anti-neutrophil cytoplasmic antibodies) are a family of autoantibodies related to vasculitis and inflammatory disorders. Since 1985, when c-anca was shown to be related to granulomatosis with polyangiitis, interest in ANCAs has steadily increased. Today these antibodies are considered to be major diagnostic tools for the diagnosis and follow up of systemic vasculitis. Comparison of Wieslab Capture ANCA PR3 assay with other methods n= 120 Wieslab Capture PR3 Linker bound PR3 Mixed PR3 antigen Direct PR3 coating Sensitivity 40/40* 37/40 29/40 34/40 % 100% 93% 73% 85% Specificity 80/80** 79/80 79/80 37/42 % 100% 99% 99% 88% *Selected material, confirmed vasculitis **Blood donors, disease controls Reference: In-house data Clinical evaluation of capture assays for determining PR3 ANCA shows that this format has a higher diagnostic sensitivity for detecting patients with GPA compared with the direct-coating method or Indirect Immunofluorescence. A follow-up study of systemic vasculitis demonstrated that a high level of PR3-ANCA detected with the capture method was associated with significantly poorer renal survival plus higher mortality. No such correlation could be seen with the direct assay. Moreover, studies also show that the capture assay displays higher sensitivity for detecting relapses, which further suggests a biological relation between disease progression and epitope specificity. Principle of the Wieslab Capture PR3 ANCA assay Microtitre plate wells are coated with anti-pr3 monoclonal antibody in complex with PR3. During the first incubation, specific autoantibodies in diluted serum bind to the antigen coating. Optical density is measured following subsequent washing and incubation steps that involve adding conjugate and substrate. Cap PR3 IU 2 Wieslab Capture PR3-ANCA 96 wells PR3 IU 2 Wieslab PR3-ANCA 96 wells FPRO DIASTAT PR3-ANCA 96 wells 1) Please contact your local representative for availability in your country, available in US! 2) Please contact your local representative for availability in your country, not available in US! Visit our website 18 I product catalog

19 MPO-ANCA Capture MPO-ANCA Wieslab Wieslab Capture MPO-ANCA test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and quantitation of IgG antibodies to Myeloperoxidase (MPO) in human sera. The assay is used to detect antibodies in a single serum specimen. Results are used to aid the of Vasculitis, in particular Microscopic polyangitiis. Background ANCAs (anti-neutrophil cytoplasmic antibodies) are a family of autoantibodies related to vasculitis and inflammatory disorders. When c-anca was shown to relate to granulomatosis with poly-angiitis (Wegener s granulomatosis (WG)), interest in ANCAs has increased steadily. Today these antibodies are considered to be major diagnostic tools for investigating systemic vasculitis. Measurement of MPO-specific ANCA is an important adjunct to clinical findings in the evaluation of clinical sub-types within the systemic vasculitides spectrum. Principle of the Wieslab Capture MPO ANCA assay Microtitre plate wells are coated with anti-mpo monoclonal antibody in complex with MPO. During the first incubation, specific autoantibodies in diluted serum bind to the antigen coating. Optical density is measured following subsequent washing and incubation steps that involve adding conjugate and substrate. The Wieslab Capture MPO-ANCA is standardized against the AF-CDC standard (Reference Human Serum 15, code IS2720). Cap MPO IU 2 Wieslab Capture MPO-ANCA 96 wells MPO IU 2 Wieslab MPO-ANCA 96 wells FMPO DIASTAT MPO-ANCA 96 wells 1) Please contact your local representative for availability in your country, available in US! 2) Please contact your local representative for availability in your country, not available in US! product catalog I 19

20 VASCULITIS Multi-parameter kits Products Anti-GBM, ANCA screen kit Wieslab A prompt diagnosis is essential for patients with medical conditions such as Goodpasture s Syndrome, granulomatosis with polyangiitis (Wegener s granulomatosis) or microscopic polyangiitis. Fast and simultaneous detection of autoantibodies against GBM, Proteinase 3 (PR3-ANCA) and Myeloperoxidase (MPO-ANCA) is possible with Wieslab Anti-GBM, ANCA Screening Test Kit. Wieslab Anti-GBM, ANCA Screening Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to glomerular basement membrane (GBM), Proteinase-3 (PR3) and Myeloperoxidase (MPO) in human sera. The assay is used to detect antibodies in a single serum specimen. GCP Anti-GBM, ANCA screen kit Wieslab Break-apart microtitration strips (6x16) 96 wells CP Wieslab ANCA screen kit Break-apart microtitration strips (12x8) 96 wells GCP-CAP Vasculitis screen Wieslab Microtitration 96 wells 1) Please contact your local representative for availability in your country, available in US! ANCA panel kit Wieslab For ANCA-positive samples that are negative for PR3-ANCA and MPO-ANCA, an extended analysis is necessary. In addition, a prompt diagnosis is essential for patients vasculitis or other inflammatory disorders. Wieslab ANCA panel kit allows screening of six other factors that have been proposed to be involved in relevant disorders. Wieslab ANCA panel test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative detection of IgG antibodies to azurocidin, BPI, cathepsin G, elastase, lactoferrin, and lysozyme in human sera. The assay is used to detect antibodies in a single serum specimen. PAN ANCA panel kit Wieslab Microtitration strips (12x8) 96 wells 2) Please contact your local representative for availability in your country, not available in US! Visit our website 20 I product catalog

21 Euro Diagnostica ANSWERS TO YOU product catalog I 21

22 GOODPASTURE S SYNDROME Goodpasture s syndrome Disease information Goodpasture s syndrome Goodpasture s syndrome is a rare autoimmune disease characterised by lung haemorrhage, rapid destruction of the kidney and the presence of antibodies to glomerular basement membrane (GBM). The GBM antigen responsible for this disease is a component of the non-collagenous domain (NC1) of the alpha-3 chain of collagen type IV. Patients with Goodpasture s syndrome develop antibodies to GBM that attack collagen in the alveoli of the lungs and the glomeruli of the kidney. As there are several other autoimmune diseases that may present with similar symptoms, detection of anti-gbm antibodies is a useful aid in differentiating between these diseases. Deposits of antibodies in the basement membrane break down collagen and interrupt membrane integrity. This causes leakage of blood and a rapid inflammatory response leading to lung haemorrhage and kidney damage. Patients with Goodpasture s syndrome experience a rapid progression to renal failure and death if the disease is not recognised and treated early. Because of the vagueness of early symptoms and its rapid progression, diagnosis is often not reached until very late in the course of the disease. Like many autoimmune diseases, Goodpasture s syndrome responds well to treatment with corticosteroids and immunosuppressants. The concentration of anti-gbm antibodies in the blood may be reduced by plasmapheresis to remove blood plasma and replace a portion of the plasma with an isotonic salt and protein solution. As with many autoimmune conditions, the precise cause of Goodpasture s Syndrome is not yet known. It is believed to be a type II hypersensitivity reaction to Goodpasture s antigens on the basement membrane of the glomerulus of the kidneys and the pulmonary alveolus. Goodpasture s syndrome is a very rare condition and its incidence in Europe is between 1 in 1,000,000 and 1 in 2,000,000. Code Name Description Page GCP Anti-GBM, ANCA screen kit Wieslab Qualitative ELISA 20 GCP-CAP 2 Vasculitis screen Wieslab Qualitative ELISA 20 GP 104X 1 Wieslab Anti-GBM semiquantitative kit FGBM DIASTAT Anti-GBM, ANCA screen kit Quantitative and qualitative ELISA Semi-quantitative ELISA ) Please contact your local representative for availability in your country, available in US! 2) Please contact your local representative for availability in your country, not available in US! Visit our website 22 I product catalog

23 Goodpasture s syndrome Products Anti-GBM semi quantitative kit Wieslab Goodpasture s syndrome is characterised by lung haemorrhage, renal failure and the presence of anti-gbm antibodies. As several other autoimmune diseases may present with similar symptoms, this kit is a useful aid in differentiating between these diseases. Intended use Wieslab anti-gbm test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to glomerular basement membrane (GBM) in human sera. The assay is used to detect antibodies in a single serum specimen. Its results aid the diagnosis of Goodpasture s syndrome. The analysis should be performed by trained laboratory professionals. Background Goodpasture s syndrome is characterised by lung haemorrhage, renal failure and the presence of anti-gbm antibodies. Diagnosis is based on clinical signs of lung haemorrhage and rapidly progressive glomerulonephritis combined with findings of anti-gbm antibodies. As several other autoimmune diseases may present with similar symptoms, this kit is a useful aid in differentiating between these diseases. Less than one third of patients with reno-pulmonary syndromes have antibodies against the Goodpasture antigen, the majority having either Proteinase 3-ANCA or Myeloperoxidase-ANCA. Historically, indirect immunofluorescence was used to detect anti-gbm antibodies. When the first ELISA based on a collagenase digest was published in 1981, assays using crude extracts were the only alternative. In 1984 the specific antigen was shown to derive from the C-terminal domain of type IV collagen (alpha 3 chain) and sensitive and specific assays were subsequently developed. The antigen is characterised by a restricted tissue distribution occurring mainly in kidney and lungs. GP 104X 1 Wieslab Anti-GBM semi quantitative kit 96 wells FGBM DIASTAT Anti-GBM, ANCA screen kit 96 wells 1) Please contact your local representative for availability in your country, available in US! product catalog I 23

24 COMPLEMENT COMPLEMENT SYSTEM FUNCTIONAL ASSESSMENT A unique diagnostic solution Simple and accurate ELISA All three pathways Lectin pathway with both MBL and Ficolin-3 Visit our website 24 I product catalog

25 Complement Disease information Complement deficiency The immune system is divided into innate immunity and adaptive immunity. Adaptive immunity is specific in its action and is constantly developing throughout life in response to and as an adaption to different pathogenic organisms. In contrast, innate immunity is inherited and acts as a first line of defense. Innate immunity includes cells and mechanisms that defend against a variety of pathogens in a non-specific mode. The complement system is an important part of the innate immune system. The complement system consists of about 30 different proteins, generally synthesized by the liver and normally circulating as inactive precursors. Stimulation by one of several trigger molecules will initiate an amplifying cascade of proteolytic cleavages. Complement can be activated by three pathways, the classical pathway, the lectin pathway and the alternative pathway. The end-result of this activation cascade is massive amplification of the response and activation of the cell-killing membrane attack complex (MAC). Complement may also act through other important mechanisms such as opsonization and chemotaxis. Complement deficiency and disease Deficiencies in complement predispose patients to infection basically via two mechanisms: (1) ineffective opsonization and (2) defects in lytic activity (defects in MAC formation). Individuals with complement deficiencies that hinder opsonization present with frequent recurrent infections and a high rate of morbidity and mortality. Patients with a defect in formation of MAC have a somewhat lesser degree of morbidity and mortality than, for example, patients with a defect in C3. Patients deficient in a lytic component of the complement cascade are at high risk for recurrent infection with Neisseria gonorrhoeae or Neisseria meningitidis. In addition to susceptibility to infections, a number of diseases are suggested to be affected by the complement system. Deficiency of the classical pathway is associated with an increased risk of developing Systemic Lupus Erythematosus (SLE). The complement system has been suggested to be involved in the pathogenesis of ANCA-associated vasculitides (AAV). Rheumatoid arthritis (RA) is affected by complement and although activation is potentially related to the occurrence of inflammation, complement deficiency may induce RA. Deficiency in the lectin pathway (MBL) seems to be associated with disease severity. Over activity of the alternative pathway, due to deficient complement inhibitor activity, has been implicated as a main cause of the seemingly unrelated pathologies of hemolytic uremic syndrome (HUS) and age-related macular degeneration (AMD). In addition, complement activity may have significant effect on the appearance and development/course of a variety of different diseases such as glomerulonephritis, atherosclerosis, Crohn s disease, Alzheimer s disease, and cardiac disease. Interest in complement and complement activity has grown exponentially over the last few years as a result of greater awareness of its important implications on a large variety of diseases and clinical conditions. Accordingly, interest in simple and accurate test methods for assessing complement function has grown significantly. Code Name Page COMPL Complement system screen Wieslab 26 COMPL AP Complement system AP Wieslab 27 COMPL CP Complement system CP Wieslab 27 COMPL MP Complement system MBL Wieslab 28 COMPLF 3 3 Complement system Ficolin 3 Wieslab 28 2) Please contact your local representative for availability in your country, not available in US! 3) For research use only, contact your local representative for research use availability in your country. product catalog I 25

26 FICOLIN 3 MASP-2 COMPLEMENT Complement Products Complement system Screen Wieslab Increased awareness and interest in the complement system has augmented the need for a simple and objective method to assess the function of complement activity. The Euro Diagnostica complement assay solution provides a complete picture of the complement function. Intended use Wieslab Complement system screen kit is an enzyme immunoassay for the qualitative determination of functional classical, MBL and alternative complement pathways in human serum. For in vitro diagnostic use. Background The complement system plays an essential role in chronic, autoimmune and infectious disease. There are three pathways of complement activation, namely the classical, the alternative and the MBL pathway. Universal detection Specific blocking Specific coating Classical Pathway Lectin Pathway C3 Membrane attack complex Alternative Pathway C1q MBL Ficolin 3 C3b/Factor b Impaired complement activity causes humans to become susceptible to repetitive fulminant or severe infections and may contribute to development of autoimmune disease. Inappropriate activation of complement contributes to chronic inflammation and tissue injury. Classical Pathway C9 Lectin Pathway MBL C9 Lectin Pathway Ficolin-3 C9 Alternative Pathway C9 Technical information Wieslab Complement assay combines principles of the hemolytic assay for complement activation with the use of labeled antibodies specific for neoantigen produced as a result of complement activation. The amount of neoantigen generated is proportional to the functional activity of complement pathways. C7 C6 C5 C3 C4 C2 C1 qrs C7 C6 C5 C3 C4 C2 MBL MASP-2 C7 C6 C5 C3 C4 C2 C7 C6 C5 C3 P FB FD IgM Mannan AcBSA LPS The wells of the microtitre strips are coated with specific activators of the classical, the MBL, or the alternative pathway. Patient serum is diluted in diluent containing specific blocker to ensure that only the respective pathway is activated. During the incubation of the diluted patient serum in the wells, complement is activated by the specific coating. The wells are then washed and C5b-9 is detected with a specific alkaline phosphatase-labelled antibody to the neoantigen expressed during MAC formation. COMPL Complement system Screen Wieslab Break-apart microtitration strips (4x8x3) 96 wells 2) Please contact your local representative for availability in your country, not available in US! Visit our website 26 I product catalog

27 Complement system Alternative Pathway Wieslab Increased awareness and interest in the complement system has augmented the need for a simple and objective method to assess the function of complement activity. The Euro Diagnostica complement assay solution provides a complete picture of the complement function. The complement system plays an essential role in chronic, autoimmune and infectious disease. There are three pathways of complement activation, namely the classical, the alternative and the MBL pathway. Wieslab COMPL AP 330 kit is an enzyme immunoassay for the qualitative determination of the functional alternative complement pathway in human serum. COMPL AP Complement system Alternative Pathway Wieslab Break-apart microtitration strips (12x8) 96 wells 2) Please contact your local representative for availability in your country, not available in US! Complement system Classical Pathway Wieslab Increased awareness and interest in the complement system has augmented the need for a simple and objective method to assess the function of complement activity. The Euro Diagnostica complement assay solution provides a complete picture of the complement function. Wieslab COMPL CP 310 is an enzyme immunoassay for the qualita tive determination of the functional classical complement pathway in human serum. COMPL CP Complement system Classical Pathway Wieslab Break-apart microtitration strips (12x8) 96 wells 2) Please contact your local representative for availability in your country, not available in US! product catalog I 27

28 COMPLEMENT Complement Products Complement system MBL Pathway Wieslab Increased awareness and interest in the complement system has augmented the need for a simple and objective method to assess the function of complement activity. The Euro Diagnostica complement assay solution provides a complete picture of the complement function. The complement system plays an essential role in chronic, autoimmune and infectious disease. There are three pathways of complement activation, namely the classical, the alternative and the MBL pathway. The Wieslab COMPL MP 320 kit is an enzyme immunoassay for the qualitative determination of the MBL complement pathway in human serum. COMPL MP Complement system MBL Pathway Wieslab Break-apart microtitration strips (12x8) 96 wells 2) Please contact your local representative for availability in your country, not available in US! Complement system Ficolin 3 Wieslab Increased awareness and interest in the complement system has augmented the need for a simple and objective method to assess the function of complement activity. The Euro Diagnostica complement assay solution provides a complete picture of the complement function. The Complement Ficolin 3 Wieslab kit is an enzyme immunoassay for the qualitative determination of Ficolin 3 in human serum. COMPLF 3 3 Complement system Ficolin 3 Wieslab 96 wells 3) For research use only, contact your local representative for research use availability in your country. Visit our website 28 I product catalog

29 Connective tissue disorders Disease information A number of systemic autoimmune diseases affect connective tissues Autoimmune connective tissue disorders may affect all connective tissues, i.e. joints, muscles, skin and blood vessels, and they therefore have multiple effects on many different organs throughout the body. The causes of autoimmune connective tissue diseases (CTD) are not known. It may involve genetic factors predisposing for the disease, although in several diseases the causal link is rather low. There is a significant female over-representation among autoimmune CTD patients. Autoimmune CTD are characterized as a group by the presence of spontaneous over-activity of the immune system that results in the introduction of extra antibodies into the circulation autoantibodies. The different diseases may develop slowly and eventually show distinct clinical symptoms, characteristic for a specific disease. However, the systemic nature of these diseases makes a differential diagnosis based on clinical signs only sometimes difficult. Different diseases often present with autoanti bodies with characteristics specific for a certain defined disease. Serological testing for these autoantibodies is thus a valuable tool in the diagnosis of autoimmune CTD. Code Name Page FANA ANA DIASTAT 30 FCEN Anti-Centromere DIASTAT 31 FALA Anti-La (SS-B) DIASTAT 31 FDNA Anti-dsDNA DIASTAT 32 FAJO Anti-Jo-1 DIASTAT 33 FMIT Anti-Mitochondria DIASTAT 33 FSCL Anti-Scl-70 DIASTAT 33 FARO Anti-Ro (SS-A) DIASTAT 34 FASM Anti-Sm DIASTAT 34 FRNP Anti-Sm/RNP DIASTAT 35 FSWS ENA-single well screen DIASTAT 35 FAID ENA profile DIASTAT 35 1) Please contact your local representative for availability in your country, available in US! product catalog I 29

30 CONNECTIVE TISSUE DISORDERS Connective tissue disorders Products ANA DIASTAT DIASTAT ELISA is an appropriate first-line screen for total anti-nuclear antibody. A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process. DIASTAT anti-nuclear antibody (ANA) test is a qualitative enzymelinked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsdna, histone and centromere antigens. The test may be used for screening to eliminate samples negative for all ANAs. Samples that give a positive result should be further tested to identify the antigen-specific antibody or antibodies present. Background Detection and serological characterisation of specific autoantibodies plays an important role in the differential diagnosis of systemic rheumatic diseases. Autoantibodies to nuclear antigens (ANAs) are a group of antibodies specific for nuclear antigens including Sm, Sm/RNP, Ro (SS A), La (SS-B), Scl-70, Jo-1, dsdna, histone and centromere antigens. A positive ANA test result provides presumptive evidence for systemic rheumatic disease and further definition of specific antibody profiles is a valuable aid in the diagnostic process. A negative result reduces, but does not exclude, the likelihood of systemic rheumatic disease. Technical information The wells of the microtitre strips are coated with highly-purified HEp-2 cell extract. During the first incubation, specific ANAs in diluted serum or EDTA plasma bind to the antigen-coated surface. The wells are then washed to remove unbound components. In the second incubation, the Conjugate, enzyme-labelled antibodies to human IgG and IgM, binds any surface-bound autoantibodies. After further washing, specific autoantibodies are traced by incubation with the Substrate. Addition of Stop Solution terminates the reaction, resulting in a coloured end-product. FANA ANA DIASTAT ELISA (96 wells) Comparison with immunofluorescence 363 serum samples from patients with connective tissue disease (CTD) were compared with immunofluorescence on samples from patients with connective tissue disease at a number of European centres. Positivity or negativity on IFA was assigned according to the trial centre criteria. IFA DIASTAT +ve -ve +ve ve Sensitivity = 86% Specificity = 94% Overall agreement = 89% Comparison with immunofluorescence by individual autoantibodies The assay was compared with immunofluorescence with individual autoantibody specificities. These were determin ed using the specific DIASTAT ELISA kits. Antibody specificity Positive (ANA) Positive (IFA) Ro (SS-A) La (SS-B) Sm Sm/RNP Scl dsdna Centromere Histone % Agreement 28 samples identified as Jo-1 positive were tested, using the DIASTAT ANA kit had the following results: 24/28 (85.7%) were positive in the ANA test. 3/28 (10.7%) fell within the borderline area. Their ratios were 0.99, 0.86 and /28 (3.6%) gave a ratio of ) Please contact your local representative for availability in your country, available in US! Visit our website 30 I product catalog