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
This study is recruiting at 6 US sites in 3 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Treponema Pallidum
- Treponema Pallidum Infection
- Syphilis Infection
- Serum
- Plasma
- Blooddraw
- Sexually Transmitted Infection (STI)
Eligibility basics and study details
- Study type
- Observational
- Phase
- Not applicable
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- American Laboratory Products Company
- Last updated on ClinicalTrials.gov
- September 16, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 2
- Chemidox Clinical Trials California · Lancaster, CA
- Folio Clinical Research · Los Angeles, CA
Florida · 2
- Segel Trials · North Miami, FL
- IMA Clinical Research - St.Petersburg · St. Petersburg, FL
Texas · 2
- Chemidox Tx LLC · Houston, TX
- VAST Clinical Research · Mesquite, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.