MedTrace Logo

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.

NCT07089836 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-02-11

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • American Laboratory Products Company

    lead INDUSTRY

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2026-06-30
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07089836 on ClinicalTrials.gov