REF:

E4101 (Microwell Plate)

INTENDED USE:

This kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative determination of the antibodies to Treponema pallidum (TP) in human serum or plasma. It is intended for screening of blood donors and as an aid for the diagnosis and management of clinical conditions known as syphilis.

SUMMARY:

Syphilis is a disease caused by Spirochete bacterium called Treponema pallidum (TP). If untreated, the organisms move throughout the body and can cause damage to many organs, making syphilis a life-threatening disease if not treated early enough. People who have been infected with Syphilis experience different symptoms during the 3 stages of the disease. Early, which is defined by the presence of the chancre at the site of inoculation. Syphilis may be further divided into primary, secondary, and early latent syphilis; late syphilis includes late latent and the various forms of tertiary Syphilis. The serological response to syphilis involves production of antibodies to a wide range of antigens, including non-specific antibodies and specific anti-TP antibodies. The first detectable response to infection is the production of specific antitreponemal IgM, which can be detected within 4 to 7 days after the chancre appears and until the end of the second week of infection; antitreponemal IgG appears at about four weeks later. By the time that symptoms develop, most patients have detectable IgG and IgM.