{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T17:56:51Z","timestamp":1791568611862,"version":"4.3.4"},"reference-count":29,"publisher":"American Society for Microbiology","issue":"6","license":[{"start":{"date-parts":[[2018,5,25]],"date-time":"2018-05-25T00:00:00Z","timestamp":1527206400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2018,6,1]],"date-time":"2018-06-01T00:00:00Z","timestamp":1527811200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100017412","name":"Becton, Dickinson and Company","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100017412","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Vaginitis is a common complaint, diagnosed either empirically or using Amsel's criteria and wet mount microscopy. This study sought to determine characteristics of an investigational test (a molecular test for vaginitis), compared to reference, for detection of bacterial vaginosis,\n                    <jats:named-content content-type=\"genus-species\">Candida<\/jats:named-content>\n                    spp., and\n                    <jats:named-content content-type=\"genus-species\">Trichomonas vaginalis<\/jats:named-content>\n                    . Vaginal specimens from a cross-sectional study were obtained from 1,740 women (\u226518 years old), with vaginitis symptoms, during routine clinic visits (across 10 sites in the United States). Specimens were analyzed using a commercial PCR\/fluorogenic probe-based investigational test that detects bacterial vaginosis,\n                    <jats:named-content content-type=\"genus-species\">Candida<\/jats:named-content>\n                    spp., and\n                    <jats:named-content content-type=\"genus-species\">Trichomonas vaginalis<\/jats:named-content>\n                    . Clinician diagnosis and in-clinic testing (Amsel's test, potassium hydroxide preparation, and wet mount) were also employed to detect the three vaginitis causes. All testing methods were compared to the respective reference methods (Nugent Gram stain for bacterial vaginosis, detection of the\n                    <jats:named-content content-type=\"genus-species\">Candida<\/jats:named-content>\n                    gene\n                    <jats:italic>its2<\/jats:italic>\n                    , and\n                    <jats:named-content content-type=\"genus-species\">Trichomonas vaginalis<\/jats:named-content>\n                    culture). The investigational test, clinician diagnosis, and in-clinic testing were compared to reference methods for bacterial vaginosis,\n                    <jats:named-content content-type=\"genus-species\">Candida<\/jats:named-content>\n                    spp., and\n                    <jats:named-content content-type=\"genus-species\">Trichomonas vaginalis<\/jats:named-content>\n                    . The investigational test resulted in significantly higher sensitivity and negative predictive value than clinician diagnosis or in-clinic testing. In addition, the investigational test showed a statistically higher overall percent agreement with each of the three reference methods than did clinician diagnosis or in-clinic testing. The investigational test showed significantly higher sensitivity for detecting vaginitis, involving more than one cause, than did clinician diagnosis. Taken together, these results suggest that a molecular investigational test can facilitate accurate detection of vaginitis.\n                  <\/jats:p>","DOI":"10.1128\/jcm.00252-18","type":"journal-article","created":{"date-parts":[[2018,4,6]],"date-time":"2018-04-06T05:58:22Z","timestamp":1522994302000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":83,"title":["Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis"],"prefix":"10.1128","volume":"56","author":[{"given":"Jane R.","family":"Schwebke","sequence":"first","affiliation":[{"name":"University of Alabama at Birmingham, Birmingham, Alabama, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte A.","family":"Gaydos","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Nyirjesy","sequence":"additional","affiliation":[{"name":"Drexel University College of Medicine, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Paradis","sequence":"additional","affiliation":[{"name":"Becton, Dickinson and Company, BD Life Sciences\u2014Diagnostic Systems, Quebec, QC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salma","family":"Kodsi","sequence":"additional","affiliation":[{"name":"Becton, Dickinson and Company, BD Life Sciences\u2014Diagnostic Systems, Sparks, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles K.","family":"Cooper","sequence":"additional","affiliation":[{"name":"Becton, Dickinson and Company, BD Life Sciences\u2014Diagnostic Systems, Sparks, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9378(12)90722-X"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199712253372607"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9343(83)91112-9"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.29.2.297-301.1991"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.rr6404a1"},{"key":"e_1_3_3_7_2","volume-title":"Trichomoniasis","author":"Centers for Disease Control and Prevention","year":"2015","unstructured":"Centers for Disease Control and Prevention. 2015. Trichomoniasis. Centers for Disease Control and Prevention, Atlanta, GA. https:\/\/www.cdc.gov\/std\/tg2015\/trichomoniasis.htm."},{"key":"e_1_3_3_8_2","volume-title":"Provider performed microscopy (PPM) procedures","author":"Centers for Medicare and Medicaid Service","year":"2016","unstructured":"Centers for Medicare and Medicaid Service. 2016. Provider performed microscopy (PPM) procedures, 42.493.19. Department of Health and Human Services, Washington, DC."},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9378(99)70433-3"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0029-7844(01)01670-2"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-015-2412-z"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1155\/2008\/750479"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000002090"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2015151516"},{"key":"e_1_3_3_15_2","first-page":"149","article-title":"An evaluation of an InPouch TV culture method for diagnosing Trichomonas vaginalis infection","volume":"67","author":"Borchardt KA","year":"1991","unstructured":"Borchardt KA, Smith RF. 1991. An evaluation of an InPouch TV culture method for diagnosing Trichomonas vaginalis infection. Genitourin Med 67:149\u2013152.","journal-title":"Genitourin Med"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02006-13"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1927.10502953"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1037\/h0028106"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.11613\/BM.2012.031"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciw329"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/0029-7844(96)00233-5"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1186\/1476-0711-5-4"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.3855\/jidc.1625"},{"key":"e_1_3_3_24_2","first-page":"142","article-title":"Comparison of conventional and modified Amsel's criteria with Nugent score and impact on PCR-based bacterial vaginosis infection status evaluation","volume":"26","author":"Beqaj S","year":"2015","unstructured":"Beqaj S, Lebed J, Smith B, Farrell M, Schwebke JR, Rivers CA, Nyirjesy P, Davis TE, Fuller D, Fife KH. 2015. Comparison of conventional and modified Amsel's criteria with Nugent score and impact on PCR-based bacterial vaginosis infection status evaluation. 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