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ENROLLING BY INVITATION
NCT07830550

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

Sponsor: American Laboratory Products Company

View on ClinicalTrials.gov

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.

Official title: ALPCO Syphilis-T (Treponema Pallidum) CLIA Kit and ALPCO Syphilis-NT (Non-Treponemal Lipoidal Antigen) CLIA Kit Blood Donation Protocol

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-10

Completion Date

2026-12

Last Updated

2026-09-22

Healthy Volunteers

Yes

Interventions

DEVICE

ALPCO Syphilis-T

Approximately 20-50 mL of whole blood will be collected during one study visit by qualified personnel using standard venipuncture procedures. The blood will be processed to obtain serum for research use in developing and evaluating the ALPCO Syphilis-T and Syphilis-NT assays.

DEVICE

ALPCO Syphilis-NT CLIA Kits

Detection of antibodies to lipoidal antigens in human serum and plasma

Locations (1)

ALPCO

Salem, New Hampshire, United States