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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.

American Laboratory Products Company · NCT07089836

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 13+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
1000
US sites recruiting
6
Study start
December 10, 2025
Record last updated
September 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ALPCO Syphilis-T; ALPCO Syphilis-NT CLIA Kits

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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.

Recruiting US locations

Study contacts (from the official record)

  • Yomi Ojutalayo · 800-592-5726 · clinops@alpco.com
  • Jim Richard · 800-592-5726 · regulatory@alpco.com
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This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA… (NCT07089836) | Bored Studies