{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T04:22:30Z","timestamp":1792556550177,"version":"4.5.0"},"reference-count":45,"publisher":"Microbiology Society","issue":"5","license":[{"start":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T00:00:00Z","timestamp":1779148800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015160","name":"Hologic","doi-asserted-by":"crossref","award":["NA"],"award-info":[{"award-number":["NA"]}],"id":[{"id":"10.13039\/100015160","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,19]]},"abstract":"<jats:p>\n                    <jats:italic>\n                      <jats:named-content content-type=\"#213368\">An erratum of this article has been published full details can be found at<\/jats:named-content>\n                    <\/jats:italic>\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/doi.org\/10.1099\/jmm.0.002185\" xlink:type=\"simple\">https:\/\/doi.org\/10.1099\/jmm.0.002185.<\/jats:ext-link>\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Introduction.<\/jats:bold>\n                    Infectious vaginitis, caused mostly by bacterial vaginosis (BV),\n                    <jats:italic>Candida<\/jats:italic>\n                    vaginitis (CV) and\n                    <jats:italic>Trichomonas<\/jats:italic>\n                    vaginitis (TV), is a common reason for primary care visits. Recent studies demonstrate the potential utility of molecular assays in replacing conventional diagnostic methods.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Hypothesis\/Gap Statement.<\/jats:bold>\n                    Different diagnostic standards are in use for BV; published studies have evaluated molecular diagnostic tests against Amsel criteria, Nugent score or a combination of both. In the UK, Hay\/Ison criteria are commonly used, but there are limited studies evaluating molecular diagnostic assays against these criteria.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Aim.<\/jats:bold>\n                    This study evaluated the performance of Hologic\u2019s Aptima\u00ae BV and CV\/TV assays relative to Hay\/Ison criteria for BV and culture for CV in women with symptoms of vaginitis attending primary care centres in the UK.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Methodology.<\/jats:bold>\n                    Paired vaginal swabs were collected from women \u226518\u2009years of age undergoing testing for\n                    <jats:italic>Chlamydia trachomatis<\/jats:italic>\n                    and\n                    <jats:italic>Neisseria gonorrhoea<\/jats:italic>\n                    using the Hologic Aptima Combo 2 (AC2) assay, alongside standard of care (SOC) testing for vaginitis (Hay\/Ison criteria for BV; culture for CV). Samples received for AC2 testing were tested for vaginitis using Hologic Aptima BV and Aptima CV\/TV assays. Sensitivity, specificity, positive and negative predictive values and diagnostic accuracy of Aptima BV and Aptima CV\/TV assays relative to SOC methodology were determined. For discrepancy analysis, selected samples were evaluated further using third-party (Thermo Fisher) Vaginal Plus and pan-Candida real-time PCR.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Results.<\/jats:bold>\n                    This study included 2,152\u2009women. The mean (standard deviation) age of participants was 35.1 (11.5) years. Sensitivity and specificity estimates for the Aptima BV assay were 98.8% and 77.7% and 94.9% and 88.3% for CV detection by Aptima CV\/TV, respectively, relative to SOC. Overall diagnostic accuracy values were 80.2% for Aptima BV and 90.0% for Aptima CV\/TV. Although not routinely tested for in our population, a limited evaluation of TV detection by the combined Aptima CV\/TV assay relative to the monoplex Aptima TV assay in 75\u2009women indicated sensitivity and specificity values of 87.5% and 100%, respectively.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Conclusion.<\/jats:bold>\n                    The Aptima BV and CV\/TV assays demonstrated high sensitivity and specificity relative to SOC methodology in UK laboratories and are a viable alternative to conventional vaginitis testing.\n                  <\/jats:p>","DOI":"10.1099\/jmm.0.002163","type":"journal-article","created":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T16:16:43Z","timestamp":1779207403000},"source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of the Hologic Aptima Vaginitis assays for microbiological diagnosis of vaginitis in women with abnormal vaginal discharge attending primary 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