{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:41:56Z","timestamp":1792798916892,"version":"4.5.0"},"reference-count":18,"publisher":"BMJ","issue":"2","funder":[{"name":"National Institute of Health and South African Medical Research Council","id":[{"id":"https:\/\/ror.org\/05q60vz69","id-type":"ROR","asserted-by":"crossref"}]},{"name":"National Institute of Health and South African Medical Research Council","id":[{"id":"https:\/\/ror.org\/05q60vz69","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2018,12,12]]},"published-print":{"date-parts":[[2019,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      Syndromic management of sexually transmitted infections (STIs) omits asymptomatic infections, particularly among women. Accurate point-of-care assays may improve STI care in low- and middle-income countries (LMICs). We aimed to evaluate the diagnostic performance of the Xpert\n                      <jats:italic>Chlamydia trachomatis<\/jats:italic>\n                      \/\n                      <jats:italic>Neisseria gonorrhoeae<\/jats:italic>\n                      (CT\/NG) and OSOM\n                      <jats:italic>Trichomonas vaginalis<\/jats:italic>\n                      (TV) Test as part of a STI care model for young women in South Africa.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Diagnostic evaluation conducted as part of a prospective cohort study (CAPRISA 083) between May 2016 and January 2017.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>One large public healthcare facility in central Durban, KwaZulu-Natal, South Africa<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>247 women, aged 18\u201340 years, attending for sexual and reproductive services to the clinic. Pregnant and HIV-positive women were excluded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcomes<\/jats:title>\n                    <jats:p>Diagnostic performance of the Xpert CT\/NG and OSOM TV assays against the laboratory-based Anyplex II STI-7 Detection. All discordant results were further tested on the Fast Track Diagnostics (FTD) STD9 assay.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We obtained vaginal swabs from 247 women and found 96.8% (239\/247) concordance between Xpert and Anyplex for CT and 100% (247\/247) for NG. All eight discrepant CT results were positive on Xpert, but negative on Anyplex. FTD STD9 confirmed three positive and five negative results, giving a confirmed prevalence of CT 15.0% (95% CI 10.5 to 19.4), NG 4.9% (2.2\u20137.5) and TV 3.2% (1.0\u20135.4). Sensitivity and specificity of Xpert CT\/NG were 100% (100-100) and 97.6% (95.6\u201399.7) for CT and 100% (100-100) and 100% (100-100) for NG. The sensitivity and specificity of OSOM TV were 75.0% (45.0\u2013100) and 100% (100-100).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The Xpert CT\/NG showed high accuracy among young South African women and combined with the OSOM TV proved a useful tool in this high HIV\/STI burden setting. Further implementation and cost-effectiveness studies are needed to assess the potential role of this assay for diagnostic STI testing in LMICs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT03407586\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\">NCT03407586<\/jats:ext-link>\n                      ; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-026888","type":"journal-article","created":{"date-parts":[[2019,2,4]],"date-time":"2019-02-04T04:27:21Z","timestamp":1549254441000},"page":"e026888","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":49,"title":["Diagnostic accuracy of the Xpert CT\/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa: a cross-sectional study"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct03407586","registry":"10.18810\/clinical-trials-gov","type":"preResults"},{"clinical-trial-number":"nct03407586","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"given":"Nigel","family":"Garrett","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nireshni","family":"Mitchev","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Farzana","family":"Osman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Naidoo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jienchi","family":"Dorward","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravesh","family":"Singh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hope","family":"Ngobese","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Rompalo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koleka","family":"Mlisana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian","family":"Mindel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,2,3]]},"reference":[{"key":"2024052011410994000_9.2.e026888.1","unstructured":"World Health Organization. Global Health Sector Strategy on Sexually Transmitted Infections 2016-2021.\u00a0Geneva, Switzerland. 2016 http:\/\/apps.who.int\/iris\/bitstream\/10665\/246296\/1\/WHO-RHR-16.09-eng.pdf?ua=1 (accessed 26 Nov 2018)."},{"key":"2024052011410994000_9.2.e026888.2","doi-asserted-by":"publisher","DOI":"10.1136\/sti.2007.026930"},{"key":"2024052011410994000_9.2.e026888.3","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-199301000-00015"},{"key":"2024052011410994000_9.2.e026888.4","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(99)02463-0"},{"key":"2024052011410994000_9.2.e026888.5","unstructured":"South African National AIDS Council. Let our actions count, South Africa\u2019s National Strategic Plan for HIV, TB and STIs 2017-2022 . Pretoria, South Africa: National Department of Health, 2017."},{"key":"2024052011410994000_9.2.e026888.6","unstructured":"World Health Organization. Annual number of GeneXpert modules procured under concessional pricing. Geneva, Switzerland: World Health Organization, 2017. http:\/\/www.who.int\/tb\/areas-of-work\/laboratory\/status_xpert_rollout_dec_2016.pdf?ua=1. (accessed 26 Nov 2018)."},{"key":"2024052011410994000_9.2.e026888.7","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0193577","article-title":"Multidisease testing for HIV and TB using the GeneXpert platform: A feasibility study in rural Zimbabwe","volume":"13","author":"Ndlovu","year":"2018","journal-title":"PLoS One"},{"key":"2024052011410994000_9.2.e026888.8","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.03461-12"},{"key":"2024052011410994000_9.2.e026888.9","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2017-053443"},{"key":"2024052011410994000_9.2.e026888.10","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0196209","article-title":"Beyond syndromic management: Opportunities for diagnosis-based treatment of sexually transmitted infections in low- and middle-income countries","volume":"13","author":"Garrett","year":"2018","journal-title":"PLoS One"},{"key":"2024052011410994000_9.2.e026888.11","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2012.05.003"},{"key":"2024052011410994000_9.2.e026888.12","doi-asserted-by":"publisher","DOI":"10.1177\/0956462414534833"},{"key":"2024052011410994000_9.2.e026888.13","unstructured":"Department of Health of South Africa. Sexually transmitted infections management guidelines 2015. Pretoria, South Africa: Department of Health of South Africa, 2015:1\u201328. https:\/\/www.health-e.org.za\/wp-content\/uploads\/2015\/06\/STIguidelines3-31-15cmyk.pdf. (accessed 26 Nov 2018)."},{"key":"2024052011410994000_9.2.e026888.14","unstructured":"Centers for Disease Control and Prevention. 2015 Sexually transmitted diseases treatment guidelines. Atlanta, United States: Centers for Disease Control and Prevention, 2015. https:\/\/www.cdc.gov\/std\/tg2015\/default.htm. (accessed 26 Nov 2018)."},{"key":"2024052011410994000_9.2.e026888.15","doi-asserted-by":"crossref","first-page":"475","DOI":"10.1093\/fampra\/cmx134","article-title":"International definition of a point-of-care test in family practice: a modified e-Delphi procedure","volume":"35","author":"Schols","year":"2018","journal-title":"Fam Pract"},{"key":"2024052011410994000_9.2.e026888.16","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01430-17"},{"key":"2024052011410994000_9.2.e026888.17","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0155383","article-title":"Acceptance of treatment of sexually transmitted infections for stable sexual partners by female sex workers in Kampala, Uganda","volume":"11","author":"Mayanja","year":"2016","journal-title":"PLoS One"},{"key":"2024052011410994000_9.2.e026888.18","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2017-018132","article-title":"Rapid diagnostic test for antenatal syphilis screening in low-income and middle-income countries: a systematic review and meta-analysis","volume":"8","author":"Phang Romero Casas","year":"2018","journal-title":"BMJ Open"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2018-026888","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,20]],"date-time":"2024-05-20T14:57:00Z","timestamp":1716217020000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2018-026888"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,2]]},"references-count":18,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2019,2]]}},"alternative-id":["10.1136\/bmjopen-2018-026888"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2018-026888","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,2]]}}}