inSTIvue™ Syphilis

inSTIvue™ Syphilis –Rapid Treponema Pallidum Test Device

Product Code: 85226400105

INTENDED USE

The InSTIvue™ Syphilis Test Device is a rapid chromatographic immunoassay for the qualitative detection of antibody to Treponema pallidum in serum, plasma or whole blood.

SUMMARY

Syphilis is a sexually transmitted disease caused by the spirochete Treponema pallidum (TP). As this organism cannot be cultured on artificial media, the diagnosis of syphilis depends on the correlation of clinical data with the specific antibody demonstrated by serological tests. Serological screening tests for syphilis utilizing the patient’s serum, plasma or whole blood and cardiolipin and lecithin as antigens are simple to perform but biological false positive (BFP) reactions occur frequently because the tests use non-treponemal antigens.

Multiple clinical stages and long periods of latent, asymptomatic infection are characteristic of syphilis. Primary syphilis is defined by the presence of a chancre at the site of inoculation. The antibodies response to the TP bacterium can be detected within 4 to 7 days after the chancre appears. The infection remains detectable until the patient receives adequate treatment. InSTIvue™ type rapid treponema antibody tests are gaining importance as screening as well as confirmatory tests because they detect the presence of antibodies specific to treponema pallidum.