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.

Part of paid clinical trials in Lancaster, California.

Sponsor
American Laboratory Products Company
Study ID
NCT07089836
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ALPCO Syphilis-T — DEVICE
    Detection of antibodies to Treponema pallidum in human serum and plasma
  • ALPCO Syphilis-NT CLIA Kits — DEVICE
    Detection of antibodies to lipoidal antigens in human serum and plasma

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Syphilis-Positive Patients
    Individuals with a current or prior diagnosis of syphilis.
  • Arm: HIV-Positive Patients
    Individuals diagnosed with HIV (may or may not overlap with other cohorts).
  • Arm: Pregnant Individuals
    Pregnant participants across all trimesters.
  • Arm: Apparently Healthy Individuals
    Participants with no known history or symptoms of syphilis.

Primary Outcome Measure

Positive and Negative Percent Agreement of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits [ Time Frame: 6 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Chemidox Clinical Trials CaliforniaLancasterCalifornia93534-
Folio Clinical ResearchLos AngelesCalifornia90036-
Segel TrialsNorth MiamiFlorida33161-
IMA Clinical Research - St.PetersburgSt. PetersburgFlorida33704-
Chemidox Tx LLCHoustonTexas77071-
VAST Clinical ResearchMesquiteTexas75149-

Find similar trials in Lancaster, CA

By research site
Chemidox Clinical Trials California· Lancaster, CAFolio Clinical Research· Los Angeles, CASegel Trials· North Miami, FLIMA Clinical Research - St.Petersburg· St. Petersburg, FLChemidox Tx LLC· Houston, TXVAST Clinical Research· Mesquite, TX

Related Studies