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NCT07089836 · ClinicalTrials.gov registry record
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.
A clinical trial of Syphilis Infection and Treponema Pallidum Infection, sponsored by American Laboratory Products Company.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 6
- Study locations
NCT07089836: Recruiting study of Syphilis Infection and Treponema Pallidum Infection, sponsored by American Laboratory Products Company.
NCT07089836 is a study of Syphilis Infection and Treponema Pallidum Infection that is actively recruiting participants, run by American Laboratory Products Company. The registered enrollment target is 1,000 participants. The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07089836, a study of Syphilis Infection and Treponema Pallidum Infection, is actively recruiting participants, sponsored by American Laboratory Products Company.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
Evaluate the clinical performance of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits in detecting antibodies to Treponema pallidum and lipoidal antigens, by comparing results against established comparator assays. Success is defined as meeting or exceeding pre-specified thresholds for Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA), with lower bounds of the 95% confidence interval ≥90%.
Conditions Studied
Interventions
- DEVICE ALPCO Syphilis-T
- DEVICE ALPCO Syphilis-NT CLIA Kits
Study Locations (6)
California
- Chemidox Clinical Trials California - Lancaster
- Folio Clinical Research - Los Angeles
Florida
- Segel Trials - North Miami
- IMA Clinical Research - St.Petersburg - St. Petersburg
Texas
- Chemidox Tx LLC - Houston
- VAST Clinical Research - Mesquite
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2025-12-10 |
| Est. Completion | 2026-07 |
What NCT07089836 shows while recruiting
NCT07089836 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 7 conditions, with Syphilis Infection appearing as the primary indexed condition, and to 2 interventions - of which ALPCO Syphilis-T is the first listed.
NCT07089836 lists 6 locations in 3 states (California, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT07089836 about?
NCT07089836 is a clinical study titled "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.". 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...
What is the current status of trial NCT07089836?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2025-12-10. Estimated completion is 2026-07.
What conditions does trial NCT07089836 study?
This clinical trial studies the following conditions: Syphilis Infection, Treponema Pallidum Infection, Serum, Sexually Transmitted Infection (STI), Treponema Pallidum.
What interventions are being tested in trial NCT07089836?
The interventions under investigation include: ALPCO Syphilis-T (DEVICE), ALPCO Syphilis-NT CLIA Kits (DEVICE).
Who is sponsoring clinical trial NCT07089836?
This trial is sponsored by American Laboratory Products Company, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07089836 being conducted?
This trial has 6 study locations across California, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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