RecruitingNCT07089836

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

Sponsor

American Laboratory Products Company

Enrollment

1,000 participants

Start Date

Dec 10, 2025

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 13 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the performance of new laboratory tests (ALPCO Syphilis-T and Syphilis-NT CLIA kits) for detecting syphilis antibodies in blood samples. The goal is to validate these tests against established syphilis diagnostics in a wide range of patients. **You may be eligible if...** - You are of any gender - You are undergoing routine syphilis testing (at-risk individuals, those with symptoms, people with prior syphilis, or high-risk individuals) - You have been previously diagnosed with syphilis in an accredited laboratory - You are willing to provide blood samples **You may NOT be eligible if...** - You are unwilling to provide the required blood samples - You do not meet the criteria for routine syphilis testing or prior diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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