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.

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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age13+

SponsorAmerican Laboratory Products Company

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients suspected of syphilis, at high-risk for syphilis, or scheduled for routine syphilis related serological testing will be enrolled in the clinical study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

ALPCO Syphilis-T
Device
Detection of antibodies to Treponema pallidum in human serum and plasma
ALPCO Syphilis-NT CLIA Kits
Device
Detection of antibodies to lipoidal antigens in human serum and plasma

Treatment groups

1,000 Participants

are divided into 4 treatment groups

Group A: Syphilis-Positive Patients2 interventions

Group B: HIV-Positive Patients2 interventions

Group C: Pregnant Individuals2 interventions

Group D: Apparently Healthy Individuals2 interventions

Trial outcomes

Primary outcomes

Positive and Negative Percent Agreement of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits

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%.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American Laboratory Products Company

Lead sponsor

Source ClinicalTrials.gov

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