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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.
Sponsor: American Laboratory Products Company
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
Conditions
Interventions
ALPCO Syphilis-T
Detection of antibodies to Treponema pallidum in human serum and plasma
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