{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T04:22:29Z","timestamp":1792556549350,"version":"4.5.0"},"reference-count":33,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2021,3,9]],"date-time":"2021-03-09T00:00:00Z","timestamp":1615248000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To validate the use of Seegene Allplex\u2122 Vaginitis assay in the diagnosis of candidiasis, bacterial vaginosis (BV) and trichomoniasis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Cross\u2010sectional, prospective study conducted in a single centre.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Outpatient clinic of a gynaecology department.<\/jats:p><\/jats:sec><jats:sec><jats:title>Population<\/jats:title><jats:p>Consecutive symptomatic and asymptomatic women (18\u201360\u00a0years of age).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Comparison of the assay test with the reference standards for the diagnosis of vaginitis (cultures for yeasts, Nugent for BV and nucleic acid amplification test for trichomoniasis).<\/jats:p><\/jats:sec><jats:sec><jats:title>Main outcome measures<\/jats:title><jats:p>Performance of the investigational assay, in comparison with the reference standards for the diagnosis of the presence of <jats:italic>Candida<\/jats:italic> spp., <jats:italic>Trichomonas vaginalis<\/jats:italic> and BV. Secondary objectives are the evaluation of the performance of the test in postmenopausal women and in symptomatic women.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A diagnosis of vaginitis was established in 14.0%. The global prevalences of BV, <jats:italic>Candida<\/jats:italic> spp. and <jats:italic>T.\u00a0vaginalis<\/jats:italic> were 22.3%, 13.2% and 2.4%, respectively. The sensitivity and specificity of the assay test for those three causes of vaginitis were as follows: BV 91.7% and 86.6%; any <jats:italic>Candida<\/jats:italic> spp. 91.1% and 95.6%; <jats:italic>Candida albicans<\/jats:italic> 88.1% and 98.2%, non<jats:italic>\u2010albicans<\/jats:italic> <jats:italic>Candida<\/jats:italic> 100% and 97.5%, and <jats:italic>T.\u00a0vaginalis<\/jats:italic> 94.4 and 99.9%. The performance of the test was identical in the subgroup of women that reported vulvovaginal symptoms. The presence of multiple infections did not interfere with the performance of the test.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The Seegene Allplex\u2122 Vaginitis assay has an excellent performance in the diagnosis of the BV and presence of <jats:italic>Candida<\/jats:italic>; the results were good for trichomoniasis, but the study was underpowered for this outcome.<\/jats:p><\/jats:sec><jats:sec><jats:title>Tweetable abstract<\/jats:title><jats:p>Seegene Allplex\u2122 Vaginitis is an excellent option for screening and diagnosis of vaginitis.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1471-0528.16661","type":"journal-article","created":{"date-parts":[[2021,2,5]],"date-time":"2021-02-05T18:01:23Z","timestamp":1612548083000},"page":"1344-1352","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Clinical validation of a new molecular test (Seegene Allplex\u2122 Vaginitis) for the diagnosis of vaginitis: a cross\u2010sectional study"],"prefix":"10.1111","volume":"128","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5335-6770","authenticated-orcid":false,"given":"P","family":"Vieira\u2010Baptista","sequence":"first","affiliation":[{"name":"Hospital Lus\u00edadas Porto Porto Portugal"},{"name":"Lower Genital Tract Unit Gynaecology Department Centro Hospitalar de S\u00e3o Jo\u00e3o Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"AR","family":"Silva","sequence":"additional","affiliation":[{"name":"LAP, a Unilabs Company Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Costa","sequence":"additional","affiliation":[{"name":"LAP, a Unilabs Company Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T","family":"Aguiar","sequence":"additional","affiliation":[{"name":"Centro Hospitalar de S\u00e3o Jo\u00e3o Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C","family":"Saldanha","sequence":"additional","affiliation":[{"name":"LAP, a Unilabs Company Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C","family":"Sousa","sequence":"additional","affiliation":[{"name":"LAP, a Unilabs Company Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,3,9]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.3122\/15572625-13-3-178"},{"key":"e_1_2_5_3_1","first-page":"484","article-title":"Etiology of vaginal\/cervical discharge syndrome: analysis of data from a referral laboratory in eastern India","volume":"63","author":"Ghosh I","year":"2018","journal-title":"Indian J Dermatol"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-319-61621-6_24"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01264-19"},{"key":"e_1_2_5_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa260"},{"key":"e_1_2_5_7_1","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.11417.1"},{"key":"e_1_2_5_8_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0074378"},{"key":"e_1_2_5_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2018.12.011"},{"key":"e_1_2_5_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13027-019-0243-8"},{"key":"e_1_2_5_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.15854"},{"key":"e_1_2_5_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.15981"},{"key":"e_1_2_5_13_1","first-page":"1","article-title":"Centers for Disease Control and Prevention. 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