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.

Launched by AMERICAN LABORATORY PRODUCTS COMPANY · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is testing two new blood test kits designed to detect syphilis, a sexually transmitted infection, by looking for antibodies in the blood. These kits, called Syphilis-T and Syphilis-NT, aim to improve how accurately syphilis is diagnosed by comparing their results with those from standard tests. The study will include people who might have syphilis, those at higher risk (such as individuals with HIV or pregnant people), as well as healthy volunteers.

If you join the study, you will be asked to provide one or two small blood samples, depending on your age and status (for example, pregnant participants or children will give one sample). The study is open to anyone 13 years and older who is either being tested for syphilis as part of routine care, has symptoms, or has had syphilis before. People currently on antibiotics or with certain medical conditions that make blood draws unsafe will not be eligible. Participants will also need to agree to the study by signing consent forms. Overall, this study hopes to help doctors better detect syphilis in different groups of people using these new testing kits.

Gender

ALL

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.
• • 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 study tubes of blood.
• • Participants must be able and willing to sign the informed consent form (ICF).
• • Participants aged 13 to 17 will be asked to sign an assent form. Written parental or guardian consent will also be required prior to enrollment. The assent form will use age-appropriate language and be reviewed with the participant before any procedures.
• Exclusion Criteria:
• • Patients currently being treated with antibiotics or completed a course of antibiotics within the past 30 days
• • Patients with pre-existing conditions that would make blood collection difficult or harmful
• • If the samples are not collected in strict accordance with the established sampling protocol, as determined by the study team.
• • Any medical, psychological, or social condition that, in the judgment of the investigator, could interfere with the participant's ability to comply with study requirements, or pose a risk to their safety, or compromise the integrity of the study.