MicroELISA

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The EIAgen Syphilis Ab Kit assay, is a third generation solid phase enzyme immunoassay for the qualitative detection of antibodies to Treponema pallidum (TP) in human sera or plasma (EDTA, Heparin Lithium, Sodium Citrate). This kit is for in vitro diagnostic use by a health-care professional and will not be sold to the general public. For “in vitro” diagnostic use only.

Syphilis is a disease caused by infection with the spirochete bacterium Treponema pallidum, ordinarily transmitted by sexual contact. However, it can also be transmitted congenitally by transplacental passage of T. pallidum to the foetus and by blood transfusion. The serological diagnosis of syphilis is performed demonstrating the presence of significant levels of specific T. pallidum antibodies in the patient serum or plasma sample. The reference method used is the FTA-ABS technique that allows the detection of both IgG and IgM. However, its execution is laborious and the interpretation of results not simple. Alternative methods have therefore been introduced to simplify the procedure: reaction with lipoidal antigens (the reagin test) or agglutination of erythrocytes coated with specific T. pallidum antigens (hemmagglutination test or TPHA). The TPHA is the preferred technique for screening purposes, since that it detects specific IgG and IgM. Unfortunately, the result of the test is determined by subjective interpretation and cannot be completely automated.

EIAgen Syphilis Ab Kit allows screening of specific IgG and IgM antibodies with the ELISA technique. This assay allows screening of specific antibodies of any class with the sandwich Enzyme Immunoassay (EIA) method using immunodominant recombinant antigens Tp15, Tp17 and Tp47. It can be completely automated.

The EIAgen Syphilis Kit is based on the ‘sandwich’ principle, a solid-phase enzyme-linked immunoassay technique, to measure anti-Treponema pallidum levels in serum or plasma.

Recombinant Antigens representing immunodominant epitopes of Treponema pallidum (Tp15, Tp17 and Tp47) are coated onto wells of a microplate. Serum or plasma specimens and Assay Diluent are added to these wells, followed by a solution of biotinylated antigens.

If antibodies specific to the antigens (IgG, IgM or IgA) are present in the specimen, they form stable complexes with the TP antigens attached to the well and the biotinylated antigens. Antigen-antibody complexes are then identified through the addition of HRP-Streptavidin conjugate. The catalytic activity of HRP allows for the quantification of these antibody-antigen complexes.

HRP substrate solution is next added, and the catalytic activity of the bound HRP conjugate allows for the proportional revelation (in blue colour) of these antibody-antigen complexes, thus establishing their presence or absence in the specimen. Wells containing specimens negative for anti-TP antibodies remain relatively colourless.

A stop solution is added to each well and the resulting yellow color is read on a microplate reader at 450 nm.

The kit contains reagents for 192 tests (code 081142).