Treponema (syphilis) IVDs

Intended purpose

iStatis Syphilis Antibody Test: The iStatis Syphilis Antibody Test is a single use, rapid, lateral-flow in vitro qualitative screening immunoassay for the detection of antibodies to Treponema pallidum (T. pallidum) in human EDTA-whole blood, fingerstick whole blood, serum or plasma. The test is intended for manual operation by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians’ offices as an aid to diagnosis for Treponema pallidum (T. pallidum) infection in adults over 18 years of age by providing results within 15 minutes. Although suitable for near-patient or point-of-care (POC) testing, it is not suitable for home testing.