{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T15:47:56Z","timestamp":1785858476322,"version":"3.56.0"},"reference-count":33,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2024,11,26]],"date-time":"2024-11-26T00:00:00Z","timestamp":1732579200000},"content-version":"vor","delay-in-days":25,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,11,1]],"date-time":"2024-11-01T00:00:00Z","timestamp":1730419200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>The introduction of self\u2010sampling in cervical cancer screening has raised the importance of HPV test validation on self\u2010collected samples. This study aimed to evaluate the clinical accuracy of the OncoPredict HPV Screening (SCR) assay on self\u2010collected vaginal and first\u2010void urine (FVU) samples, relative to cervical specimens, using the VALHUDES Framework. FVU and vaginal self\u2010samples followed by a clinician\u2010collected cervical brushing were collected from 500 women referred to colposcopy and tested using OncoPredict HPV SCR assay. The assay demonstrated clinical sensitivity to detect cervical intraepithelial neoplasia grade 2 or worse (\u2265 CIN2) similar to cervical samples in FVU (ratio: 0.95, [95% CI: 0.88\u20131.02]) and vaginal self\u2010samples (ratio: 0.96 [95% CI: 0.90\u20131.02]). The clinical specificity for &lt;\u2009CIN2 was lower in vaginal (ratio: 0.90 [95% CI: 0.84\u20130.96]) but not in FVU samples (ratio: 1.03 [95% CI: 0.96\u20131.12) when compared to cervical samples. However, the relative specificity improved following cut\u2010off optimization (ratio: 0.94, 95% CI: [0.88\u20131.01]). Moderate to excellent agreement in HPV detection between self\u2010collected and cervical samples was demonstrated (Kappa values: 0.53\u20131.00). To conclude, OncoPredict HPV SCR assay demonstrated similar accuracy on FVU and cervical samples. On vaginal compared to cervical samples sensitivity was similar with a lower specificity, which improved with cut\u2010off optimization.<\/jats:p>","DOI":"10.1002\/jmv.70079","type":"journal-article","created":{"date-parts":[[2024,11,26]],"date-time":"2024-11-26T05:47:40Z","timestamp":1732600060000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Clinical Performance of OncoPredict HPV Screening Assay on Self\u2010Collected Vaginal and Urine Specimens Within the VALHUDES Framework"],"prefix":"10.1002","volume":"96","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6112-7572","authenticated-orcid":false,"given":"Chiara","family":"Giubbi","sequence":"first","affiliation":[{"name":"School of Medicine and Surgery University of Milano\u2010Bicocca Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2273-6986","authenticated-orcid":false,"given":"Marianna","family":"Martinelli","sequence":"additional","affiliation":[{"name":"School of Medicine and Surgery University of Milano\u2010Bicocca Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7361-3081","authenticated-orcid":false,"given":"Ardashel","family":"Latsuzbaia","sequence":"additional","affiliation":[{"name":"Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2604-3928","authenticated-orcid":false,"given":"Kate","family":"Cuschieri","sequence":"additional","affiliation":[{"name":"Scottish HPV Reference Laboratory, Department of Lab Medicine Royal Infirmary of Edinburgh NHS Lothian Edinburgh UK"},{"name":"HPV Research Group, Centre for Reproductive Health University of Edinburgh Edinburgh UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hana","family":"Elasifer","sequence":"additional","affiliation":[{"name":"Scottish HPV Reference Laboratory, Department of Lab Medicine Royal Infirmary of Edinburgh NHS Lothian Edinburgh UK"},{"name":"HPV Research Group, Centre for Reproductive Health University of Edinburgh Edinburgh UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6909-1228","authenticated-orcid":false,"given":"Anna Daniela","family":"Iacobone","sequence":"additional","affiliation":[{"name":"Preventive Gynecology Unit European Institute of Oncology IRCCS Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1838-0163","authenticated-orcid":false,"given":"Fabio","family":"Bottari","sequence":"additional","affiliation":[{"name":"General Clinical Laboratory with Specialized Areas Clinical Pathology \u2013 Microbiology and Virology European Institute of Oncology IRCCS Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea Fausto","family":"Piana","sequence":"additional","affiliation":[{"name":"Department of Medicine, Surgery and Pharmacy University of Sassari Sassari Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Pietri","sequence":"additional","affiliation":[{"name":"U.O. 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