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

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.

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