{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T20:56:07Z","timestamp":1793998567485,"version":"4.8.0"},"reference-count":29,"publisher":"BMJ","funder":[{"DOI":"10.13039\/501100003130","name":"Fonds Wetenschappelijk Onderzoek","doi-asserted-by":"publisher","award":["1SB0225N"],"award-info":[{"award-number":["1SB0225N"]}],"id":[{"id":"10.13039\/501100003130","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100007229","name":"Bijzonder Onderzoeksfonds UGent","doi-asserted-by":"publisher","award":["BOF.COV.2020.0009.01"],"award-info":[{"award-number":["BOF.COV.2020.0009.01"]}],"id":[{"id":"10.13039\/501100007229","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Sex Transm Infect"],"accepted":{"date-parts":[[2025,9,8]]},"abstract":"<jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Vulvovaginal candidiasis is the second most common cause of vaginitis among women of childbearing age worldwide and is often self-diagnosed and self-treated by women. However, self-management of vaginal symptoms has been shown to have very poor outcomes. Hence, reliable self-tests are essential for improving the management of VVC. Here, we evaluated and compared the diagnostic performance of four marketed <jats:italic>Candida<\/jats:italic> self-tests.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Remnant diagnostic material was collected from 140 vaginal samples analysed by culture in the Netherlands. This was used in four commercially available <jats:italic>Candida<\/jats:italic> self-tests: <jats:italic>Candida albicans<\/jats:italic> Rapid Test Beright, StrongStep <jats:italic>Candida albicans<\/jats:italic> Antigen Rapid Test, Tigsun VVC-TV-GV Combo Antigen Test and VagiQUICK. Furthermore, DNA was extracted and used to quantify <jats:italic>Candida<\/jats:italic> using qPCR. The performance of each test was compared with culture and qPCR results using appropriate statistical methods.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The Beright, StrongStep, Tigsun and VagiQUICK tests exhibited sensitivities of 47.3%, 30.8%, 73.0% and 66.3% and specificities of 100%, 100%, 100% and 97.4%, respectively, compared with culture. Compared with qPCR, the tests exhibited a sensitivity of 43.4%, 60.2%, 60.8% and 54.7% and a specificity of 89.7%, 73.3%, 80.0% and 75.9%, respectively. Sensitivity improved with increasing <jats:italic>Candida<\/jats:italic> concentration thresholds.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The investigated self-tests demonstrated varying performances, with both sensitivity and specificity being consistently lower than manufacturer claims. These findings underscore the urgent need for developing and validating more reliable self-tests to support adequate management of women\u2019s health. The sensitivity of currently marketed tests is only slightly better than empirical or self-diagnosis, which limits their clinical utility.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/sextrans-2025-056642","type":"journal-article","created":{"date-parts":[[2025,9,24]],"date-time":"2025-09-24T17:20:23Z","timestamp":1758734423000},"page":"sextrans-2025-056642","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Evaluation of the diagnostic performance of four self-tests for vulvovaginal candidiasis"],"prefix":"10.1136","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4822-9272","authenticated-orcid":false,"given":"Lisa","family":"Himschoot","sequence":"first","affiliation":[{"name":"Department of Diagnostic Sciences, Ghent University, Ghent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aylien","family":"Vanraepenbusch","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Sciences, Ghent University, Ghent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Selis","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Sciences, Ghent University, Ghent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Meakin","sequence":"additional","affiliation":[{"name":"Global Access Diagnostics Ltd, Bedford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yevgeniy","family":"Blumin","sequence":"additional","affiliation":[{"name":"Bayer Consumer Care AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daphn\u00e9 A","family":"Schmid","sequence":"additional","affiliation":[{"name":"Bayer Consumer Care AG, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4897-4261","authenticated-orcid":false,"given":"Sylvia M","family":"Bruisten","sequence":"additional","affiliation":[{"name":"Public Health Laboratory, Public Health Service of Amsterdam, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piet","family":"Cools","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Sciences, Ghent University, Ghent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,9,24]]},"reference":[{"key":"2025092410201562000_sextrans-2025-056642v1.1","doi-asserted-by":"publisher","DOI":"10.3109\/1040841X.2015.1091805"},{"key":"2025092410201562000_sextrans-2025-056642v1.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)60917-9"},{"key":"2025092410201562000_sextrans-2025-056642v1.3","doi-asserted-by":"publisher","DOI":"10.3314\/mmj.22.004"},{"key":"2025092410201562000_sextrans-2025-056642v1.4","doi-asserted-by":"crossref","DOI":"10.1186\/s12941-020-0347-4","article-title":"Microbiota in vaginal health and pathogenesis of recurrent vulvovaginal infections: a critical review","volume":"19","author":"Kalia","year":"2020","journal-title":"Ann Clin Microbiol Antimicrob"},{"key":"2025092410201562000_sextrans-2025-056642v1.5","doi-asserted-by":"publisher","DOI":"10.1001\/jama.291.11.1368"},{"key":"2025092410201562000_sextrans-2025-056642v1.6","doi-asserted-by":"crossref","unstructured":"Vieira-Baptista P , Sobel J . International Society for the Study of Vulvovaginal Disease recommendations for the diagnosis and treatment of vaginitis. 2023. doi:10.59153\/adm.rdtv.001","DOI":"10.59153\/adm.rdtv.001"},{"key":"2025092410201562000_sextrans-2025-056642v1.7","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1097\/AOG.0000000000005529","article-title":"A comparison of newer and traditional approaches to diagnosing vaginal infections","volume":"143","author":"Powell","year":"2024","journal-title":"Obstet Gynecol"},{"key":"2025092410201562000_sextrans-2025-056642v1.8","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1808418"},{"key":"2025092410201562000_sextrans-2025-056642v1.9","doi-asserted-by":"crossref","DOI":"10.1186\/s12905-023-02260-z","article-title":"Scoping review of the association between bacterial vaginosis and emotional, sexual and social health","volume":"23","author":"Brusselmans","year":"2023","journal-title":"BMC Womens Health"},{"key":"2025092410201562000_sextrans-2025-056642v1.10","doi-asserted-by":"publisher","DOI":"10.1080\/713683045"},{"key":"2025092410201562000_sextrans-2025-056642v1.11","unstructured":"Hildebrand JP , Kansagor AT . 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Tigsun vvc-tv-gv combo antigen test. 2021."},{"key":"2025092410201562000_sextrans-2025-056642v1.23","doi-asserted-by":"crossref","DOI":"10.1007\/s11908-015-0488-3","article-title":"The role of PCR in the diagnosis of Candida vulvovaginitis-a new gold standard?","volume":"17","author":"Sobel","year":"2015","journal-title":"Curr Infect Dis Rep"},{"key":"2025092410201562000_sextrans-2025-056642v1.24","doi-asserted-by":"publisher","DOI":"10.1016\/S0029-7844(99)00577-3"},{"key":"2025092410201562000_sextrans-2025-056642v1.25","doi-asserted-by":"publisher","DOI":"10.1111\/j.1439-0507.2006.01312.x"},{"key":"2025092410201562000_sextrans-2025-056642v1.26","doi-asserted-by":"publisher","DOI":"10.1258\/09564620360719796"},{"key":"2025092410201562000_sextrans-2025-056642v1.27","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0313774","article-title":"Free DNA partially clarifies discrepancies between qPCR and the conventional phage quantification method","volume":"19","author":"Van Overfelt","year":"2024","journal-title":"PLoS One"},{"key":"2025092410201562000_sextrans-2025-056642v1.28","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1038\/s41564-018-0295-3","article-title":"REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes","volume":"4","author":"Land","year":"2019","journal-title":"Nat Microbiol"},{"key":"2025092410201562000_sextrans-2025-056642v1.29","unstructured":"World Health Organization . 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