2 - 8 °C
Syphilis is a chronic infection which progresses through distinct stages of infection: primary, secondary, tertiary and quaternary. These stages produce diverse clinical symptoms, typically producing initial chancres then syphilitic rash followed by long periods of dormancy and may eventually lead to cardiovascular problems and neurosyphilis. Caused by the spirochaete Treponema pallidum, infection is usually acquired by sexual contact. The disease may be transmitted by transfusion of infected blood and also intrauterine infection occurs. Tests for syphilis fall into four categories: direct microscopic examination; treponemal antibody tests; non-treponemal antibody tests and direct antigen tests. Because of the long periods of dormancy and the non-specific nature of non-treponemal tests, methods which detect specific anti-treponemal antibodies in patient samples are important for the diagnosis of the infection. TPHA is one such test.
The Cypress Diagnostics kit TPHA is an in vitro diagnostic medical device intended to be used for the qualitative detection of Treponema pallidum IgG and IgM antibodies in human serum and EDTA plasma. The device is not automated. The detection of Treponema pallidum IgG and IgM antibodies is intended to be used to aid in the diagnosis of syphilis. The test population are patients with a suspected syphilis infection or at elevated risk of syphilis infection. This assay is not intended for blood screening or as a confirmatory assay on donor samples. This kit is intended to be used by Professional use - Healthcare professionals in a laboratory-based testing environment.