SeraSpot® Anti-Treponema-4 IgG / IgM

Intended use:

The SeraSpot® Anti-Treponema-4 IgG / SeraSpot® Anti-Treponema-4 IgM is an in vitro diagnostic device (spotimmunoassay, SIA) for the detection of Treponema pallidum-specific IgG or IgM antibodies in human serum or plasma samples. The test can be used as a confirmatory test after a positive or a questionable result of a syphilis screening test (TPHATPPA-or TPLA-test).

General information:

Treponema pallidum ssp. pallidum is the causative agent of Syphilis, a sexually transmitted globally spread disease in humans. The clinical course of Syphilis is characterized by different stages with varying symptoms. Infection occurs by sexual contacts. Skin lesions but also intact mucosa in the genital, oral or anal region are the most likely sites of entry for the pathogen and from there it spreads via blood and lymph vessels. During this primary stage a painless ulcus (ulcus durum) develops at the site of entry and a swelling of the regional lymph nodes (lymphadenopathy). Without treatment the infection will enter into the secondary stage after 9-10 weeks. Clinical signs are patchy papular exanthema or other ulcerative skin irritations, accompanied by several less characteristic symptoms like lymphadenopathy, fatigue, weight loss, subfebrile temperatures etc. The papular skin rashes contain a large number of pathogens. In the course of the secondary stage, which lasts between weeks to months, specific antibodies are produced. Nevertheless reinfections may occur. After decline of the symptoms and a latency period of up to several years the tertiary stage with a wide range of symptoms depending on the respective organ manifestations develops. Involvement of the central nervous system results in the clinical picture of Neurosyphilis or other neurological manifestations (1, 2).

Treponema pallidum infections are diagnosed either by direct (pathogen detection or PCR) or indirect (serology) methods.

Test principle:

The SeraSpot® Anti-Treponema-4 IgG / SeraSpot® Anti-Treponema-4 IgM is a solid phase immunoassay based on the use of recombinant Treponema antigens as capture antigens printed in array arrangement (spot array) on the bottom of the wells of 96 well-microtiter plates. The recombinant antigens serve as capture molecules for antibodies against Treponema antigens. Bound antibodies are detected by Horseradish Peroxidase-(HRP)-labeled antibodies against human

antibodies of IgG- or IgM-type by substrate reaction with hydrogen peroxide and 3,3’,5,5’- Tetramethylbenzidine (TMB). At the site of formed immune complexes blue spots are developed by precipitated product from colorless substrate solution. Color intensity is correlated to the antibody concentration. Pale blue to dark blue spots are visible by eye.

Art. No.:

• IgG antibodies: SP-010-4 G-S6 (1×48) / SP-010-4 G-S12 (1×96)
• IgM antibodies: SP-010-4 M-S6 (1×48) / SP-010-4 M-S12 (1×96)