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

NCT07830550 · tracked via the Priya Life Science USA tracker

Sponsor

American Laboratory Products Company

Phase

Observational

Started

2026-10

Last updated

2026-09-22

Condition(s) studied

Healthy VolunteersSyphilis Serologic Assay DevelopmentBlood Specimen CollectionDiagnostic Assay DevelopmentSerum Specimen Collection

Investigational drug(s) / intervention(s)

ALPCO Syphilis-TALPCO Syphilis-NT CLIA Kits

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.

ALPCO Syphilis-NT CLIA Kits: Detection of antibodies to lipoidal antigens in human serum and plasma

Study 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

Sex

ALL

Min age

22 Years

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Number of Blood Specimens Successfully Processed Into Serum — Day 1, following the single study visit and serum processing
The number of enrolled participants from whom approximately 20-50 mL of whole blood is successfully collected and processed into serum suitable for research use in the development and performance evaluation of the ALPCO Syphilis-T and Syphilis-NT assays.

Trial sites (1)

Facility	City	Region	Status
ALPCO	Salem	New Hampshire

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07830550 on ClinicalTrials.gov ↗ ← All trials in the USA