ALPCO Syphilis-T and Syphilis-NT CLIA Kits: Detection of Antibodies to Treponema Pallidum and Against Lipoidal Antigens in Human Serum and Plasma
American Laboratory Products Company
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.
Description
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…
Eligibility
- Age range
- 13+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DeviceALPCO Syphilis-T
Detection of antibodies to Treponema pallidum in human serum and plasma
- DeviceALPCO Syphilis-NT CLIA Kits
Detection of antibodies to lipoidal antigens in human serum and plasma
Locations (6)
- Chemidox Clinical Trials CaliforniaLancaster, California
- Folio Clinical ResearchLos Angeles, California
- Segel TrialsNorth Miami, Florida
- IMA Clinical Research - St.PetersburgSt. Petersburg, Florida
- Chemidox Tx LLCHouston, Texas
- VAST Clinical ResearchMesquite, Texas