● Recruiting

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.

Condition: Treponema Pallidum · Treponema Pallidum Infection · Syphilis Infection · Sponsor: American Laboratory Products Company

PhaseN/A

Planned participants1000

Who can joinAll sexes, 13 Years to no upper limit

Healthy volunteersYes

About this study

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 description comes directly from the study's public registry record.

Talk to the study team

Yomi Ojutalayo · 800-592-5726 · clinops@alpco.com

Jim Richard · 800-592-5726 · regulatory@alpco.com

Always discuss trial participation with your own doctor first.

Locations (6)

Chemidox Clinical Trials California	Lancaster, California, United States	Recruiting
Folio Clinical Research	Los Angeles, California, United States	Recruiting
Segel Trials	North Miami, Florida, United States	Recruiting
IMA Clinical Research - St.Petersburg	St. Petersburg, Florida, United States	Recruiting
Chemidox Tx LLC	Houston, Texas, United States	Recruiting
VAST Clinical Research	Mesquite, Texas, United States	Recruiting

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Source record: clinicaltrials.gov/study/NCT07089836