Treponema (syphilis) IVDs

Intended purpose

For the in vitro qualitative detection of antibodies produced by the body in patients suspected of or at risk of infection with Treponema pallidum as an aid in the diagnosis of syphilis. Samples tested may include human serum, EDTA plasma and/or CSF. The assay may also be used to determine the titre level of the samples. Not intended for blood screening or as a confirmatory assay on donor samples.