This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.

Not yet recruitingOBSERVATIONAL

Enrollment

1,000

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions

Treponema PallidumTreponema Pallidum InfectionSyphilis InfectionSerumPlasmaBlooddrawSexually Transmitted Infection (STI)

Interventions

DEVICE

ALPCO Syphilis-T

Detection of antibodies to Treponema pallidum in human serum and plasma

DEVICE

ALPCO Syphilis-NT CLIA Kits

Detection of antibodies to lipoidal antigens in human serum and plasma