Validation of Rapid Point-of-Care Diagnostic Tests for Sexually Transmitted Infection Self-Testing Among Adolescent Girls and Young Women.

Background/Objectives: High rates of sexually transmitted infections (STIs) increase HIV transmission risk among adolescent girls and young women (AGYW) in South Africa. AGYW prefer discreet self-testing options for HIV and pregnancy; however, other STI self-testing options are currently unavailable in this region. Methods: Seven Chlamydia trachomatis (CT), Neisseria gonorrhea (NG) and Trichomonas vaginalis (TV) assays were validated for AGYW self-test use (using self-collected vaginal samples) in a cross-sectional study (PROVE). Paired GeneXpert® NG/CT (Cepheid®, Sunnyvale, CA, USA) and OSOM® Trichomonas test (Sekisui Diagnostics, Burlington, MA, USA) results from nurse-collected samples served as reference results to calculate sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV). One test, the polymerase chain reaction (PCR)-based Visby Medical™ Sexual Health Test device (Visby Medical™, San Jose, CA, USA), was validated for accuracy of positive test results using self-collected samples and home-based testing in a longitudinal follow-up study enrolling AGYW aged 16-18 years. Paired GeneXpert® NG/CT and TV results from nurse-collected vaginal samples served as reference tests. Results: In PROVE, 146 AGYW contributed 558 paired samples. The Visby Medical™ Sexual Health Test exhibited moderate to high sensitivity (66.7-100%), specificity (80-100%), NPV (66.7-100%), and PPV (66.7-100%) for NG, CT, and TV. The remaining tests' performances were markedly lower. In the longitudinal study, 28 AGYW contributed 84 paired samples, and the Visby Medical™ Sexual Health Test demonstrated 100% accuracy of positive results for CT, NG, and TV. Conclusions: The Visby Medical™ Sexual Health Test demonstrated high reliability as a potential option for AGYW to discreetly self-test for multiple STIs concurrently. Testing of its acceptability, utility, and feasibility in a larger sample of AGYW is in progress.