{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T15:10:31Z","timestamp":1772982631928,"version":"3.50.1"},"reference-count":31,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2022,12,27]],"date-time":"2022-12-27T00:00:00Z","timestamp":1672099200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2022,12,27]],"date-time":"2022-12-27T00:00:00Z","timestamp":1672099200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100000780","name":"European Commission","doi-asserted-by":"publisher","award":["847845"],"award-info":[{"award-number":["847845"]}],"id":[{"id":"10.13039\/501100000780","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Human papillomavirus (HPV) assays used in cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV\u00ae Screening (SCR) is a partial genotyping multiplex real\u2010time PCR assay targeting E6\/E7 genes of 13 high\u2010risk (hr) HPVs. OncoPredict HPV\u00ae SCR (index assay) identifies HPV\u201016 and HPV\u201018 separately, 11 other hrHPV in aggregate and includes quality controls for sample adequacy, DNA extraction efficiency and PCR inhibition. 1300 VALGENT\u20102 study samples (from women aged 20\u201360 attending the Scottish cervical cancer screening program) were tested with the index assay and the GP5+\/6+ PCR enzyme immunoassay (standard comparator assay). Non\u2010inferior accuracy detecting cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) of the index versus comparator was verified. Intra\u2010 and interlaboratory reproducibility of the index was evaluated by overall concordance and Cohen's kappa, using a sub\u2010population (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009526). Relative sensitivity and specificity for CIN2+\u00a0of the index versus comparator were 1.01 (95% confidence interval [CI]: 0.99\u20131.03) and 1.02 (95%\u00a0CI: 1.0\u20131.04), respectively. Noninferiority\n                    <jats:italic>p<\/jats:italic>\n                    \u00a0values were all \u22640.05, except for CIN3+\u00a0in patients \u226530 years. Excellent intra\u2010 and interlaboratory reproducibility was shown with concordance &gt;98% and kappas &gt;0.95. OncoPredict HPV\u00ae SCR fulfills the three international validation criteria for hrHPV DNA tests in cervical cancer screening.\n                  <\/jats:p>","DOI":"10.1002\/jmv.28417","type":"journal-article","created":{"date-parts":[[2022,12,21]],"date-time":"2022-12-21T08:47:27Z","timestamp":1671612447000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of the clinical performance of OncoPredict HPV\u00ae SCR assay within the VALGENT\u20102 framework"],"prefix":"10.1002","volume":"95","author":[{"given":"Sharonjit K.","family":"Dhillon","sequence":"first","affiliation":[{"name":"Unit of Cancer Epidemiology\/Belgian Cancer Centre Scientific Institute of Public Health  Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6166-1134","authenticated-orcid":false,"given":"Clementina E.","family":"Cocuzza","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Microbiology and Virology, Department of Medicine and Surgery University of Milano\u2013Bicocca  Monza Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pui Yan Jenny","family":"Chung","sequence":"additional","affiliation":[{"name":"Unit of Cancer Epidemiology\/Belgian Cancer Centre Scientific Institute of Public Health  Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marianna","family":"Martinelli","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Microbiology and Virology, Department of Medicine and Surgery University of Milano\u2013Bicocca  Monza Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiara","family":"Giubbi","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Microbiology and Virology, Department of Medicine and Surgery University of Milano\u2013Bicocca  Monza Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruth C.","family":"Njoku","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Microbiology and Virology, Department of Medicine and Surgery University of Milano\u2013Bicocca  Monza Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5294-0668","authenticated-orcid":false,"given":"Ramya","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Scottish HPV Reference Laboratory Royal Infirmary of Edinburgh  Edinburgh Scotland UK"},{"name":"HPV Research Group, Centre for Reproductive Health University of Edinburgh  Edinburgh Scotland UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kate","family":"Cuschieri","sequence":"additional","affiliation":[{"name":"Scottish HPV Reference Laboratory Royal Infirmary of Edinburgh  Edinburgh Scotland UK"},{"name":"HPV Research Group, Centre for Reproductive Health University of Edinburgh  Edinburgh Scotland UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"Arbyn","sequence":"additional","affiliation":[{"name":"Unit of Cancer Epidemiology\/Belgian Cancer Centre Scientific Institute of Public Health  Brussels Belgium"},{"name":"Department of Human Structure and Repair, Faculty of Medicine and Health Sciences University Ghent  Ghent Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,12,27]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"International Agency forResearch on Cancer.Cervical Cancer Screening. 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