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

Overview

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.

Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum. Laboratory diagnosis commonly includes treponemal tests, which detect antibodies specific to T. pallidum, and non-treponemal tests, which detect antibodies associated with cellular damage and may help assess disease activity. Serum collected under this study will serve as a human serum matrix for preparing contrived specimens. These specimens may be created by adding characterized reactive serum or other appropriately characterized materials to produce predefined levels of treponemal or non-treponemal reactivity. Before use, the serum may be evaluated using appropriate reference or comparator methods to confirm its suitability. The resulting specimens will support analytical and, when scientifically and regulatorily appropriate, clinical performance evaluations of the ALPCO Syphilis-T and Syphilis-NT assays. The specific preparation procedures, target reactivity levels, testing methods, and acceptance criteria will be defined in the applicable performance-study protocols.

Conditions