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

作者：Krishnaveni Reddy, Jiaying Hao, Nompumelelo Sigcu, Merusha Govindasami, Nomasonto Matswake, Busisiwe Jiane, Reolebogile Kgoa, Lindsay Kew, Nkosiphile Ndlovu, Reginah Stuurman, Hlengiwe Mposula, Jennifer E. Balkus, Renee Heffron, Thesla Palanee‐Phillips · 发表于：Diagnostics · 年份：2025 · DOI：10.3390/diagnostics15131604 · 被引用次数：5 · 研究领域：Reproductive tract infections research、Adolescent Sexual and Reproductive Health、Syphilis Diagnosis and Treatment

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’ performa...