Evaluation of ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Blood Samples from At-Risk, HIV-Positive, Pregnant, and Healthy Individuals

What this Trial Is About

Researchers are evaluating two investigational diagnostic kits developed by ALPCO, the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit, to detect antibodies related to syphilis infection in human serum and plasma. The study includes individuals suspected of having syphilis, those at high risk, HIV-positive patients, pregnant individuals, and healthy controls. The goal is to compare the kits performance to established reference tests and determine their positive and negative agreement rates. Participants will provide blood samples tested using the automated KleeYa platform at up to three clinical sites. The Syphilis-T kit detects antibodies to Treponema pallidum, while the Syphilis-NT kit detects antibodies to non-treponemal lipoidal antigens. Reference results will come from FDA-cleared treponemal and non-treponemal tests. The study aims to confirm that both kits meet predefined performance standards, including achieving at least 95% positive and negative agreement rates. During the study, blood samples will be collected from participants undergoing routine testing or with prior diagnoses. Pregnant individuals and children will provide one blood tube others will provide two. Participants aged 13 to 17 will provide assent with parental consent. The primary outcome measured is the positive and negative percent agreement of the kits over six months. The study involves healthy volunteers and participants of all genders aged 13 and older.

This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.