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Evaluating ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Syphilis Detection

This study is evaluating two new diagnostic kits, the ALPCO Syphilis-T and Syphilis-NT CLIA Kits, which are designed to detect syphilis antibodies in blood (serum and plasma). Researchers want to see how well these kits work compared to current, established tests. You might be able to join if you are undergoing routine syphilis testing, have a history of syphilis, are HIV-positive, pregnant, or a healthy volunteer. The study aims to show that these new kits are at least 95% accurate in identifying both positive and negative syphilis cases. The current recruitment status is unclear.

Study design
This is an observational study that plans to enroll 1000 participants. It will collect blood samples from individuals to evaluate the performance of the new diagnostic kits.
What's involved
You would provide blood samples for testing. The study does not specify how many visits or procedures are involved.
Compensation
Not stated in the trial record.
Follow-up
The primary results will be measured at 6 months. It is not specified if there is follow-up after this time.

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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.

Recruiting
Not specifiedAges 13+Observational
American Laboratory Products Company
~1,000 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:ALPCO Syphilis-TALPCO Syphilis-NT CLIA Kits

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Positive and Negative Percent Agreement of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits
Measured over 6 months

Conditions

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

Explore related trials

Syphilis

Where it's being run

6 sites across 3 states
California2
Florida2
Texas2

Who to contact

Yomi Ojutalayo
[email protected]
800-592-5726
Email the study team

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Eligibility criteria

Inclusion

Male, Female, or Other(s)
Patients undergoing routine syphilis testing (asymptomatic at risk, suspected with symptoms, prior history of syphilis, high risk for syphilis) or previously diagnosed with syphilis through a test performed in an accredited laboratory.
Participants must be willing to provide the required blood samples for the clinical study, in addition to any samples requested by their physician.
Pregnant individuals and children (under 22): 1 clinical study tube of blood.
All other participants (excluding pregnant individuals and children): 2 clinical study tubes of blood.
Participants must be able and willing to sign the informed consent form (ICF).
Participants aged 13 to 17 will be asked to sign an assent form. Written parental or guardian consent will also be required prior to enrollment. The assent form will use age-appropriate language and be reviewed with the participant before any procedures.

Exclusion

Patients currently being treated with antibiotics or completed a course of antibiotics within the past 30 days
Patients with pre-existing conditions that would make blood collection difficult or harmful
If the samples are not collected in strict accordance with the established sampling protocol, as determined by the study team.
Any medical, psychological, or social condition that, in the judgment of the investigator, could interfere with the participant's ability to comply with study requirements, or pose a risk to their safety, or compromise the integrity of the study.

What this trial measures

  • Positive and Negative Percent Agreement of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits6 months

    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%.