Recruiting

Syphilis-T & Syphilis-NT

Sponsor:

American Laboratory Products Company

Code:

NCT07089836

Conditions

Treponema Pallidum

Treponema Pallidum Infection

Syphilis Infection

Serum

Plasma

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Interventions

ALPCO Syphilis-T

ALPCO Syphilis-NT CLIA Kits

Study Details

Brief 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.

Conditions

Treponema Pallidum

Treponema Pallidum Infection

Syphilis Infection

Serum

Plasma

Study ID

NCT07089836

Start date

Dec 10, 2025

Status verified date

Feb, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Syphilis-Positive Patients

Individuals with a current or prior diagnosis of syphilis.

HIV-Positive Patients

Individuals diagnosed with HIV (may or may not overlap with other cohorts).

Pregnant Individuals

Pregnant participants across all trimesters.

Apparently Healthy Individuals

Participants with no known history or symptoms of syphilis.

Interventions

ALPCO Syphilis-T

Detection of antibodies to Treponema pallidum in human serum and plasma

ALPCO Syphilis-NT CLIA Kits

Detection of antibodies to lipoidal antigens in human serum and plasma

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Yomi Ojutalayo

800-592-5726clinops@alpco.com

Jim Richard

800-592-5726regulatory@alpco.com

Locations

Chemidox Clinical Trials California

Recruiting

Lancaster, California, United States, 93534

Folio Clinical Research

Recruiting

Los Angeles, California, United States, 90036

Segel Trials

Recruiting

North Miami, Florida, United States, 33161

IMA Clinical Research - St.Petersburg

Recruiting

St. Petersburg, Florida, United States, 33704

Chemidox Tx LLC

Recruiting

Houston, Texas, United States, 77071

VAST Clinical Research

Recruiting

Mesquite, Texas, United States, 75149

More Information

Sponsor

American Laboratory Products Company

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • Non Treponema
  • Treponema
  • Syphilis
  • Sample Collection
  • Treponema pallidum
  • Non-treponemal test
  • Chemiluminescent immunoassay
  • HIV-positive
  • Pregnant women
  • Blood sample collection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by American Laboratory Products Company on 2026-02-11.