{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T16:04:00Z","timestamp":1790697840241,"version":"4.1.0"},"reference-count":40,"publisher":"MDPI AG","issue":"13","license":[{"start":{"date-parts":[[2025,6,25]],"date-time":"2025-06-25T00:00:00Z","timestamp":1750809600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000060","name":"U.S. National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["R01AI155000"],"award-info":[{"award-number":["R01AI155000"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"U.S. National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["R34MH126743"],"award-info":[{"award-number":["R34MH126743"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000025","name":"U.S. National Institute of Mental Health","doi-asserted-by":"publisher","award":["R01AI155000"],"award-info":[{"award-number":["R01AI155000"]}],"id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000025","name":"U.S. National Institute of Mental Health","doi-asserted-by":"publisher","award":["R34MH126743"],"award-info":[{"award-number":["R34MH126743"]}],"id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>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\u00ae NG\/CT (Cepheid\u00ae, Sunnyvale, CA, USA) and OSOM\u00ae 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\u2122 Sexual Health Test device (Visby Medical\u2122, 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\u201318 years. Paired GeneXpert\u00ae 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\u2122 Sexual Health Test exhibited moderate to high sensitivity (66.7\u2013100%), specificity (80\u2013100%), NPV (66.7\u2013100%), and PPV (66.7\u2013100%) for NG, CT, and TV. The remaining tests\u2019 performances were markedly lower. In the longitudinal study, 28 AGYW contributed 84 paired samples, and the Visby Medical\u2122 Sexual Health Test demonstrated 100% accuracy of positive results for CT, NG, and TV. Conclusions: The Visby Medical\u2122 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.<\/jats:p>","DOI":"10.3390\/diagnostics15131604","type":"journal-article","created":{"date-parts":[[2025,6,25]],"date-time":"2025-06-25T03:53:02Z","timestamp":1750823582000},"page":"1604","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Validation of Rapid Point-of-Care Diagnostic Tests for Sexually Transmitted Infection Self-Testing Among Adolescent Girls and Young Women"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3881-2704","authenticated-orcid":false,"given":"Krishnaveni","family":"Reddy","sequence":"first","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1695-3696","authenticated-orcid":false,"given":"Jiaying","family":"Hao","sequence":"additional","affiliation":[{"name":"Department of Medicine, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, AL 35294, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nompumelelo","family":"Sigcu","sequence":"additional","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-1332-4333","authenticated-orcid":false,"given":"Merusha","family":"Govindasami","sequence":"additional","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nomasonto","family":"Matswake","sequence":"additional","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Busisiwe","family":"Jiane","sequence":"additional","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reolebogile","family":"Kgoa","sequence":"additional","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsay","family":"Kew","sequence":"additional","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-3206-9666","authenticated-orcid":false,"given":"Nkosiphile","family":"Ndlovu","sequence":"additional","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reginah","family":"Stuurman","sequence":"additional","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hlengiwe","family":"Mposula","sequence":"additional","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer Ellen","family":"Balkus","sequence":"additional","affiliation":[{"name":"School of Public Health, University of Washington, Seattle, WA 98195, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renee","family":"Heffron","sequence":"additional","affiliation":[{"name":"Department of Medicine, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, AL 35294, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thesla","family":"Palanee-Phillips","sequence":"additional","affiliation":[{"name":"Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2001, South Africa"},{"name":"School of Public Health, University of Washington, Seattle, WA 98195, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,6,25]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"548","DOI":"10.2471\/BLT.18.228486","article-title":"Chlamydia, gonorrhoea, trichomoniasis and syphilis: Global prevalence and incidence estimates, 2016","volume":"97","author":"Rowley","year":"2019","journal-title":"Bull. 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