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RECRUITING
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.

Sponsor: American Laboratory Products Company

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

13 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2025-12-10

Completion Date

2026-07

Last Updated

2026-02-11

Healthy Volunteers

Yes

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

Locations (6)

Chemidox Clinical Trials California

Lancaster, California, United States

Folio Clinical Research

Los Angeles, California, United States

Segel Trials

North Miami, Florida, United States

IMA Clinical Research - St.Petersburg

St. Petersburg, Florida, United States

Chemidox Tx LLC

Houston, Texas, United States

VAST Clinical Research

Mesquite, Texas, United States