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.
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
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.
Eligibility
Sex
ALL
Min age
13 Years
Max age
—
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.
Primary outcome measure(s)
Positive and Negative Percent Agreement of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits — 6 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%.
Trial sites (6)
Facility
City
Region
Status
Chemidox Clinical Trials California
Lancaster
California
Recruiting
Folio Clinical Research
Los Angeles
California
Recruiting
Segel Trials
North Miami
Florida
Recruiting
IMA Clinical Research - St.Petersburg
St. Petersburg
Florida
Recruiting
Chemidox Tx LLC
Houston
Texas
Recruiting
VAST Clinical Research
Mesquite
Texas
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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