{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T03:11:32Z","timestamp":1787973092907,"version":"build-2784847793"},"reference-count":20,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2018,11,19]],"date-time":"2018-11-19T00:00:00Z","timestamp":1542585600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Department of Reproductive Health and Research, World Health Organization (WHO)"},{"name":"\u00d6rebro County Council Research Committee and the Foundation for Medical Research at \u00d6rebro University Hospital"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["APMIS"],"published-print":{"date-parts":[[2018,12]]},"abstract":"<jats:p>Effective tests for diagnosis of sexually transmitted infections (<jats:styled-content style=\"fixed-case\">STI<\/jats:styled-content>s), used point of care to inform treatment and management decisions, are urgently needed. We evaluated the analytical sensitivity and specificity of the Xpert<jats:sup>\u00ae<\/jats:sup> <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">NG<\/jats:styled-content> and Xpert<jats:sup>\u00ae<\/jats:sup> <jats:styled-content style=\"fixed-case\">TV<\/jats:styled-content> tests, examining 339 samples spiked with phenotypically and\/or genetically diverse strains of <jats:italic>Neisseria gonorrhoeae<\/jats:italic>,<jats:italic> Chlamydia trachomatis<\/jats:italic>, and <jats:italic>Trichomonas vaginalis<\/jats:italic>, and other related species that may cross\u2010react. The <jats:styled-content style=\"fixed-case\">APTIMA<\/jats:styled-content> Combo 2 test and <jats:styled-content style=\"fixed-case\">APTIMA TV<\/jats:styled-content> test were used as reference tests. The analytical sensitivity for all three agents in the Xpert<jats:sup>\u00ae<\/jats:sup> <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">NG<\/jats:styled-content> and Xpert<jats:sup>\u00ae<\/jats:sup> <jats:styled-content style=\"fixed-case\">TV<\/jats:styled-content> tests was \u226410<jats:sup>2<\/jats:sup> genome equivalents\/reaction. The analytical specificity of both tests was high. False\u2010positive results were identified in the Xpert<jats:sup>\u00ae<\/jats:sup> <jats:styled-content style=\"fixed-case\">TV<\/jats:styled-content> test when challenging with high concentrations of <jats:italic>Trichomonas tenax<\/jats:italic>,<jats:italic> Trichomonas gallinae, Trichomonas stableri<\/jats:italic>, and <jats:italic>Trichomonas aotus<\/jats:italic>. However, the clinical relevance of these cross\u2010reactions can likely be neglected, because these species have not been identified in urogenital samples from humans. In conclusion, the analytical sensitivity and specificity of the user\u2010friendly Xpert<jats:sup>\u00ae<\/jats:sup> <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">NG<\/jats:styled-content> and Xpert<jats:sup>\u00ae<\/jats:sup> <jats:styled-content style=\"fixed-case\">TV<\/jats:styled-content> tests on the GeneXpert system were high. The results support the use of specimens from also extra\u2010genital sites, for example, pharynx and rectum. However, appropriate clinical validations are additionally required.<\/jats:p>","DOI":"10.1111\/apm.12902","type":"journal-article","created":{"date-parts":[[2018,11,20]],"date-time":"2018-11-20T04:36:03Z","timestamp":1542688563000},"page":"907-912","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":54,"title":["WHO laboratory validation of Xpert<sup>\u00ae<\/sup> CT\/NG and Xpert<sup>\u00ae<\/sup> TV on the GeneXpert system verifies high performances"],"prefix":"10.1111","volume":"126","author":[{"given":"Susanne","family":"Jacobsson","sequence":"first","affiliation":[{"name":"WHO Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections National Reference Laboratory for Sexually Transmitted Infections Department of Laboratory Medicine Faculty of Medicine and Health \u00d6rebro University \u00d6rebro Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iryna","family":"Boiko","sequence":"additional","affiliation":[{"name":"Clinical Laboratory Department Ternopil Regional Clinical Dermatovenerologic Dispensary Ternopil Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Golparian","sequence":"additional","affiliation":[{"name":"WHO Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections National Reference Laboratory for Sexually Transmitted Infections Department of Laboratory Medicine Faculty of Medicine and Health \u00d6rebro University \u00d6rebro Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karel","family":"Blondeel","sequence":"additional","affiliation":[{"name":"Department of Reproductive Health and Research World Health Organization (WHO) Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Kiarie","sequence":"additional","affiliation":[{"name":"Department of Reproductive Health and Research World Health Organization (WHO) Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Igor","family":"Toskin","sequence":"additional","affiliation":[{"name":"Department of Reproductive Health and Research World Health Organization (WHO) Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosanna W.","family":"Peeling","sequence":"additional","affiliation":[{"name":"London School of Hygiene and Tropical Medicine (LSHTM) London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magnus","family":"Unemo","sequence":"additional","affiliation":[{"name":"WHO Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections National Reference Laboratory for Sexually Transmitted Infections Department of Laboratory Medicine Faculty of Medicine and Health \u00d6rebro University \u00d6rebro Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,11,19]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0143304"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2013-051057"},{"key":"e_1_2_5_4_1","volume-title":"Laboratory Diagnosis of Sexually Transmitted Infections, Including Human Immunodeficiency Virus","author":"Unemo M","year":"2013"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/sti.2006.024265"},{"key":"e_1_2_5_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2017-053192"},{"key":"e_1_2_5_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-053067"},{"key":"e_1_2_5_8_1","doi-asserted-by":"publisher","DOI":"10.1586\/14737159.2014.871495"},{"key":"e_1_2_5_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-053063"},{"key":"e_1_2_5_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkw288"},{"key":"e_1_2_5_11_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00806-13"},{"key":"e_1_2_5_12_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.03461-12"},{"key":"e_1_2_5_13_1","first-page":"1021","article-title":"Validation of the GeneXpert\u00ae CT\/NG assay for use with male pharyngeal and rectal swabs","volume":"3","author":"Geiger R","year":"2016","journal-title":"Austin J HIV AIDS Res"},{"key":"e_1_2_5_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2017-053303"},{"key":"e_1_2_5_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2015-052384"},{"key":"e_1_2_5_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-053063"},{"key":"e_1_2_5_17_1","unstructured":"Xpert\u00aeTV.Package insert 301\u20102885 Rev D. January2017."},{"key":"e_1_2_5_18_1","doi-asserted-by":"publisher","DOI":"10.1017\/S0031182013002096"},{"key":"e_1_2_5_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijppaw.2013.12.002"},{"key":"e_1_2_5_20_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0145993"},{"key":"e_1_2_5_21_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2014-051997"}],"container-title":["APMIS"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapm.12902","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apm.12902","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/apm.12902","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apm.12902","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T17:47:44Z","timestamp":1694368064000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apm.12902"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,11,19]]},"references-count":20,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2018,12]]}},"alternative-id":["10.1111\/apm.12902"],"URL":"https:\/\/doi.org\/10.1111\/apm.12902","archive":["Portico"],"relation":{},"ISSN":["0903-4641","1600-0463"],"issn-type":[{"value":"0903-4641","type":"print"},{"value":"1600-0463","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,11,19]]},"assertion":[{"value":"2018-08-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-10-09","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-11-19","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}