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.

This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit. These kits are designed to detect antibodies to Treponema pallidum and non-treponemal lipoidal antigens, respectively, in human serum and plasma using the automated KleeYa platform. The study will collect and analyze blood samples from individuals suspected of having syphilis, those at high risk, HIV-positive patients, pregnant individuals, and healthy controls. The aim is to determine the kits' Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to established reference assays.

NCT Number	NCT07089836
Lead Sponsor	American Laboratory Products Company
Conditions	Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum, Plasma, Blooddraw, Sexually Transmitted Infection (STI)
Enrollment	1,000 participants
Start Date	2025-12-10
Primary Completion	2026-06 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2026-02-11