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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.

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 2026 → Dec 2026
See other at-risk trials from American Laboratory Products Company

Record History

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  1. Primary completion pushed from Jun 2026 to Dec 2026
    • Study completion pushed from Jul 2026 to Dec 2026
    • Eligibility criteria expanded, about 11 words
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Nov 2025 to Jun 2026
    • Start date changed from estimate of Aug 2025 to Dec 10, 2025
    • Study sites: 0 to 6
    • Study completion date: Nov 2025 to Jul 2026
  3. Interventions: ALPCO Syphilis-T and Syphilis-NT CLIA Kits: (Device) to ALPCO Syphilis-NT CLIA Kits (Device), ALPCO Syphilis-T (Device)v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07089836
Lead Sponsor American Laboratory Products Company
Conditions
(from sponsor)		 Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum, Plasma, Blooddraw, Sexually Transmitted Infection (STI)
Related terms HIV Seropositivity, Sexually Transmitted Diseases, Syphilis, Treponemal Infections
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov