NCT07089836

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.

ALPCO Syphilis-T and Syphilis-NT CLIA Kits: Detection of Antibodies to Treponema Pallidum and Against Lipoidal Antigens in Human Serum and Plasma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: American Laboratory Products Company · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a multicenter, prospective clinical collection study designed to evaluate the diagnostic performance of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits. The study will enroll individuals undergoing routine syphilis testing, those with a history of syphilis, HIV-positive individuals, pregnant individuals, and healthy volunteers. Blood samples will be collected, processed, and tested across up to three clinical sites using the investigational kits. Reference results will be determined using validated, FDA-cleared treponemal and non-treponemal tests. For the treponemal assay, results will be considered accurate if they match at least two of the three reference tests. The primary objective is to demonstrate that both kits meet or exceed prespecified performance criteria, including ≥95% positive and negative percent agreement (≥99% NPA for the non-treponemal kit), with the lower bound of the 95% confidence interval at or above 90%.

Conditions

• Treponema Pallidum
• Treponema Pallidum Infection
• Syphilis Infection
• Serum
• Plasma
• Blooddraw
• Sexually Transmitted Infection (STI)

Interventions

Type	Name	Description
DEVICE	ALPCO Syphilis-T	Detection of antibodies to Treponema pallidum in human serum and plasma
DEVICE	ALPCO Syphilis-NT CLIA Kits	Detection of antibodies to lipoidal antigens in human serum and plasma

Timeline

• Start date: 2025-12-10
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-07-28
• Last updated: 2026-02-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study