Blood Donation Study for ALPCO Syphilis-T and Syphilis-NT Assay Development

Conditions: Healthy Volunteers, Syphilis Serologic Assay Development, Blood Specimen Collection, Diagnostic Assay Development, Serum Specimen Collection

Sex: All

Ages: 22 Years – N/A

Healthy volunteers: Yes

Enrollment: 50

Sponsor: American Laboratory Products Company

Summary

This prospective, single-center study will collect blood from approximately 50 adult volunteers aged 22 years or older. Participants will provide informed consent, complete an eligibility review, and undergo one blood draw of approximately 20-50 mL. The blood will be processed into serum and labeled with a study identification number. The serum may be used to prepare laboratory samples with defined antibody levels to support the development and performance evaluation of the ALPCO Syphilis-T and Syphilis-NT assays. All testing is for research purposes only. Individual test results will not be provided to participants or used for diagnosis or treatment.

Eligibility Criteria

Inclusion Criteria: * Male or female adults aged 22 years or older * Able and willing to provide written informed consent * Able and willing to provide a blood sample in accordance with the protocol Exclusion Criteria: * Unable or unwilling to provide written informed consent * Unable or unwilling to undergo venipuncture * Any medical condition that would make blood collection unsafe, as determined by study personnel

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07830550). StuddyBuddy aggregates publicly available trial information.