Actively 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.
Led by American Laboratory Products Company · Updated on 2026-02-11
1000
Participants Needed
6
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, Female, or Other(s)
- Patients undergoing routine syphilis testing, including those asymptomatic but at risk, suspected with symptoms, with prior history, or high risk for syphilis
- Participants willing to provide required blood samples for the study
- Pregnant individuals and children (under 22) to provide 1 blood sample tube
- All other participants to provide 2 blood sample tubes
- Ability and willingness to sign informed consent
- Participants aged 13 to 17 must sign assent form with parental or guardian consent
You will not qualify if you...
- Current antibiotic treatment or completed antibiotic course within past 30 days
- Pre-existing conditions that make blood collection difficult or harmful
- Samples not collected according to established protocol
- Any medical, psychological, or social condition that may interfere with compliance, safety, or study integrity as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Chemidox Clinical Trials California
Lancaster, California, United States, 93534
Actively Recruiting
2
Folio Clinical Research
Los Angeles, California, United States, 90036
Actively Recruiting
3
Segel Trials
North Miami, Florida, United States, 33161
Actively Recruiting
4
IMA Clinical Research - St.Petersburg
St. Petersburg, Florida, United States, 33704
Actively Recruiting
5
Chemidox Tx LLC
Houston, Texas, United States, 77071
Actively Recruiting
6
VAST Clinical Research
Mesquite, Texas, United States, 75149
Actively Recruiting
Research Team
Y
Yomi Ojutalayo
CONTACT
J
Jim Richard
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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