ELISA-Range Sekisui Virotech GmbH

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1 Quelle: ELISA-Range Sekisui Virotech GmbH

2 Virotech ELISA Product Range at a Glance The Virotech ELISA product range consists > 40 CE marked ELISA test systems for qualitative, semiquantitative and quantitative detection of the most important infectious diseases serology parameters. They are intended for the detection of specific IgG, IgM and IgA antibodies in human serum. The following tests are available: Tick Panel Borrelia afzelii + VlsE TBE Herpes Panel CMV HSV 1 (gg1) HSV 2 (gg2) HSV Screen EBV EBNA EBV VCA EBV Early EBV Screen VZV Special Panel Brucella Enterovirus Helicobacter pylori Measles Mumps Yersinia enterocolitica Treponema pallidum Screen (polyvalent) Validation Kit (plus Pipetting Control) Mycosis Panel Candida Vaccination Panel Diphtheria Tetanus Respiratory Panel Adenovirus Bordetella pertussis Pertussis Toxin Influenza A Influenza B Mycoplasma pneumoniae Parainfluenza 1 to 3 Parascreen RSV

3 Diagnostic with a System! The Sekisui Virotech Diagnostic System offers great flexibility due to the fact that serum dilution and washing buffer, substrate, citrate stop solution and conjugate parameters can be used on any of the Virotech ELISAs (they are not lot depending). All tests have the following characteristics same user-friendly protocol identical serum dilution identical interpretation via ready to use cut-off controls ready to use controls, conjugates, substrates conjugates and controls well-defined by coloured vial caps depending on their ab-class colour coded microtiter plates microtiter plates with breakable wells identical incubation time ( ) for all Virotech ELISAs identical borderline ranges 9VE 11VE suitable for all automatic ELISA devices user-friendly software Package Contents Quantitative ELISA Testkits 12 microtiter strips with breakable wells dilution buffer, wash solution controls and 6 standards to prepare a standard curve anti-human IgG conjugate substrate solution, stop solution test protocol sheet Semiquantitative ELISA Testkits 12 microtiter strips with breakable wells dilution buffer, wash solution controls: negative, cut-off, positive, IgG, IgM, IgA referring to the test format anti-human-conjugates IgG, IgM, IgA referring to the test format substrate solution, stop solution test protocol sheet All controls are available as separate conrol sets! All other components can be ordered separately too!

4 CSF Diagnosis We are offering a wide range of infectious diseases serology kits for CSF diagnosis, for measurement of specific antibodies in serum and CSF. Our CSF-ELISA are available world-wide since many years and have been proven in routine diagnostic. Thanks to long-term collaboration with CSF specialists we have been able to undertake broad evaluation with more than 100 CSF-Sera-pairs from a very wide range of neurological clinical pictures. The CSF ELISAs can also be used in the well known Virotech System. Using a curve created with 4 standards or a previously established standard curve allows measurement of the ratio of CSF and serum antibodies required for calculation of the antibody index. The antibody index estimation is performed using the Reiber method. Suitable choices of the dilution ratio of CSF and serum allow the matrix effects to be eliminated. Advantages of the Virotech CSF Diagnosis 12 microtiter strips with breakable wells user friendly, general serum or CSF dilution ready-to-use reagents (except washing solution) general conjugates, substrates, stopping solutions standard curve using 4 standards or fixed standard curve parallel processing of CSF and serum in the Virotech System user friendly software suitable for all automated instruments high precision and accuracy demonstrated in External Proficiency Tests CSF Standards Borrelia afzelii + VlsE TBE Measles CMV HSV 1 (gg1) Mumps EBV HSV 2 (gg2) VZV Influenza B HSV Screen Rubella (only fix standard curve) Antibody Index Control Check of Accuracy and Precision of your AI determination Quality Control in your daily CSF routine diagnostic CSF/serum control pair for the normal range (AI <1,5) CSF/serum control pair for the pathologic range (AI >1,5)

5 Special Features Borrelia afzelii + VlsE IgG pko strain (European B. afzelii strain), B. garinii strain PBr and B. burgdorferi strain ZS7 In vivo expressed VlsE antigen to increase the sensitivity in early Lyme-Borreliosis for IgG Virotech Borrelia Europe LINE and Borrelia in vivo LINE available plus CSF tool Borrelia afzelii IgM pko strain (European B. afzelii strain), B. garinii strain PBr and B. burgdorferi strain ZS7 High sensitivity through marked OspC expressing Borrelia afzelii strain pko Virotech Borrelia Europe LINE and Borrelia in vivo LINE available plus CSF tool Diphtheria & Tetanus Check vaccination status and vaccination results regular calibration against WHO standard Quantitative determination in IU/ml (WHO-Standard) via 4PL method possible EBV EBV Screen, EBV EA-D, EBV EBNA 1, EBV VCA IgG, EBV VCA IgM gp 125 Diagnostic Factor for a clear differentiation between primary infection an past infection if EBNA 1 IgG and VCA IgM are positive Virotech EBV LINE Immuno Assay available; Double-cut-off strategy for EBNA 1 interpretation depending on the IgM serology leads to a safe differentiation between primary or past infection FSME/TBE In IgG a quantitative determination of the Vienna units is possible via the 4PL method. Use the additionally available Quantification Set. Influenza A & B Annual updated antigen strains corresponding to the recommendations of the WHO for the used vaccine

6 Special Features Mycoplasma pneumoniae IgG adjustment for the diagnosis of acute infections Specific infants cut-off Defined antigen fractions due to monospecific sera Additional use of recombinant proteins NEW: Virotech LINE Immuno Assay available Mycoplasma pn. polyvalent NEW Efficient diagnostic with IgA + IgM combined conjugate Cut-off adjustment to detect acute infections in IgG too Specific infants cut-off Use of monospecific sera to define antigen fractions Optimised mix of native and recombinant antigens NEW: Virotech LINE Immuno Assay available Pertussis Toxin NEW: Quanitification in IU/ml for IgG Kit available (WHO standard as first international reference) Calibrated against the WHO standard Differentiation between vaccination antibodies and acute infections! IgG antibodies of at least 100U/ml (corresponding to 17 VEs) against PT indicate an acute or recent infection No cross reactions reported Virotech B. pertussis + CatACT LINE Immuno Assay available: Statement to Parapertussis possible VZV IgG used on recommendation of the RKI (calibrated using WHO Standard: > 100IU/I = seropositive titer) Recording the immune status of at-risk patients Specific urea buffer in IgM = good differentiation against antibody titers due to other herpes family viruses

7 Validation of ELISA Processors The ELISA is intended for the regular check of ELISA processors (fully- or semi-automated). It shall show the accumulated effect of unprecision during pipetting, washing, incubating and measuring on the photometer and therefore confirm the validity of results obtained. According to EG guideline 98/79 appendix1, 3.1 it is required to ensure the functioning of a combination of two independent medical products (in this case ELISA processor and ELISA). The validation kit is designed to enable the user to do so. Features Testkit for the validation of ELISA processors (fully- or semi-automated) proof if combination ELISA-processor and ELISA leads to valid results a complete microtiter plate is tested with one serum procedure referring to the Virotech user manual (except pipetting step) Interpretation Software for the Validationkit (EC250.00) Treatment with Ch-B.: Processor: OD-values A B C D E F G H n = 0 x = 0 Min 0 s = 0 Max 0 A B C D E F G H Interpretation Software available! CV = 0 % Hot Spot Analysis (x >20) in % A (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) A B (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) B C (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) C D (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) D E (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) E F (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) F G (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) (%) G H (%) (%) (%) (%) 0 (%) (%) (%) (%) (%) (%) (%) (%) H Hot Spots n = 0 Interpretation Release Criteria CV: CV < 10% Release Criteria Hot Spot Analysis: < 4 Hot Spots Contact us for detailed information! If both interpretation criteria are fulfilled, the processor is working reliably. If one or even both interpretation criteria are not fulfilled, the processor should be checked thoroughly and the test should be repeated. REV Date and Signature of the responsible person

8 Sekisui Virotech GmbH Your reliable partner for infectious diseases serology & microbiology F_VTELISA_Palette_ e Sekisui Virotech GmbH Loewenplatz Ruesselsheim Germany Tel.: +49 (0) / Fax: +49 (0) / info@sekisuivirotech.com