The serological diagnosis of syphilis is performed by demonstrating the presence of significant levels of specific Treponema pallidum (TP) antibodies in the serum sample. The reference method used is the FTA-ABS technique but its execution is laborious and the interpretation of the results is not simple; alternative methods have therefore been introduced to simplify the procedure. The TPHA test is the preferred technique for screening purposes, in as far as it detects specific Ig even at low titers. Unfortunately, the result of the test is determined by subjective interpretation as the test cannot be completely automated. The TPHA test is not sensitive in the primary phase. The kits allows screening with the ELISA method. It reveals the presence of specific antibodies of any class, and can be completely automated. The specific assay of IgM as opposed to IgG is of particular importance in the diagnosis of congenital Syphilis.
Method:
Immunoenzymatic method for the qualitative determination of IgG and IgM-class antibodies to Treponema pallidum and immunoglobulins to Syphilis in human serum, using a disposable device applied on the Chorus and Chorus TRIO instruments.The test is based on the ELISA principle (Enzyme Linked ImmunoSorbent Assay) which uses the reaction between the antibodies present in the tested sample and the immobilized antigen bound to solid phases.The immunoglobulins bind to the antigen through incubation with diluted human serum.The disposable devices contain all the reagents to perform the test when applied on the Chorus instruments. The results is expressed as an INDEX (ratio between the OD value of the sample and that of the Cut-off).