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.

Recruiting Observational Study
Treponema Pallidum Treponema Pallidum Infection Syphilis Infection Serum Plasma Blooddraw Sexually Transmitted Infection (STI)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
13 and older
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
American Laboratory Products Company · Industry
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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 i…
Trial Locations
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Eligibility 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. * Participant…
Contacts

Yomi Ojutalayo

800-592-5726

clinops@alpco.com

CONTACT

Jim Richard

800-592-5726

regulatory@alpco.com

CONTACT