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

Part of paid clinical trials in Salem, New Hampshire.

Sponsor
American Laboratory Products Company
Study ID
NCT07830550
Status
Enrolling By Invitation

Conditions

  • Blood Specimen Collection
  • Diagnostic Assay Development
  • Healthy Volunteers
  • Serum Specimen Collection
  • Syphilis Serologic Assay Development

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ALPCO Syphilis-T — DEVICE
    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.
  • ALPCO Syphilis-NT CLIA Kits — DEVICE
    Detection of antibodies to lipoidal antigens in human serum and plasma

Study Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Adult Volunteer Blood Donors
    Adult volunteers aged 22 years or older who provide one blood sample for serum collection and research use.

Primary Outcome Measure

Number of Blood Specimens Successfully Processed Into Serum [ Time Frame: Day 1, following the single study visit and serum processing ]

Locations (1)

FacilityCityStateZIPSite coordinators
ALPCOSalemNew Hampshire03079-

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By research site
ALPCO· Salem, NH

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