An observational study in Treponema Pallidum, Treponema Pallidum Infection and Syphilis Infection, sponsored by American Laboratory Products Company. Recruiting at 6 sites in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by American Laboratory Products Company · Observational
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.
This is a multicenter, prospective clinical collection study designed to evaluate the diagnostic performance of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits. The study will enroll individuals undergoing routine syphilis testing, those with a history of syphilis, HIV-positive individuals, pregnant individuals, and healthy volunteers. Blood samples will be collected, processed, and tested across up to three clinical sites using the investigational kits. Reference results will be determined using validated, FDA-cleared treponemal and non-treponemal tests. For the treponemal assay, results will be considered accurate if they match at least two of the three reference tests. The primary objective is to demonstrate that both kits meet or exceed prespecified performance criteria, including ≥95% positive and negative percent agreement (≥99% NPA for the non-treponemal kit), with the lower bound of the 95% confidence interval at or above 90%.
126 studies on the registry are indexed under Syphilis; 34 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 400 across 39 observational studies indexed under Syphilis.
Browse Syphilis studies →American Laboratory Products Company is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Patients suspected of syphilis, at high-risk for syphilis, or scheduled for routine syphilis related serological testing will be enrolled in the clinical study.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with a current or prior diagnosis of syphilis.
Device: ALPCO Syphilis-T · Device: ALPCO Syphilis-NT CLIA Kits
Individuals diagnosed with HIV (may or may not overlap with other cohorts).
Device: ALPCO Syphilis-T · Device: ALPCO Syphilis-NT CLIA Kits
Pregnant participants across all trimesters.
Device: ALPCO Syphilis-T · Device: ALPCO Syphilis-NT CLIA Kits
Participants with no known history or symptoms of syphilis.
Device: ALPCO Syphilis-T · Device: ALPCO Syphilis-NT CLIA Kits
Detection of antibodies to Treponema pallidum in human serum and plasma
Detection of antibodies to lipoidal antigens in human serum and plasma
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
Plan to share: No
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