{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T17:16:35Z","timestamp":1787937395024,"version":"build-2784847793"},"reference-count":18,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T00:00:00Z","timestamp":1786924800000},"content-version":"vor","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"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":["101162959"],"award-info":[{"award-number":["101162959"]}],"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":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    International guidelines require that human papillomavirus (HPV) assays intended for primary cervical cancer screening demonstrate adequate reproducibility and non\u2010inferior clinical accuracy compared with validated comparator assays. The clinical performance of the Sansure Human Papillomavirus DNA Diagnostic Kit (Sansure HPV Kit), a multiplex real\u2010time PCR assay detecting HPV16 and HPV18 individually and 13 additional HPV types in aggregate, was evaluated according to the Meijer study design. The applied Ct cut\u2010off for HPV\u2010positivity was \u2264\u200939. A panel of 890 clinician\u2010collected cervical samples from women aged \u2265\u200930 years participating in routine screening in Belgium, including 90 histologically confirmed CIN2+ cases and 800\u2009\u2264\u2009CIN1 controls was collated. The Abbott RealTime High Risk HPV assay served as the comparator test. Non\u2010inferiority margins were \u2265\u20090.90 for relative sensitivity and \u2265\u20090.98 for relative specificity. Reproducibility was assessed through re\u2010analysis of previously published data. After exclusion of four invalid samples, 886 samples were included in the accuracy analysis. Relative sensitivity compared with Abbott RealTime was 0.978 (95% CI: 0.947\u20131.009; p\n                    <jats:italic>non\u2010inferiority<\/jats:italic>\n                    \u2009=\u20090.007) for CIN2+ and 0.966 (95% CI: 0.921\u20131.013; p\n                    <jats:italic>non\u2010inferiority<\/jats:italic>\n                    \u2009=\u20090.045) for CIN3+. Relative specificity for \u2264\u2009CIN1 was 1.003 (95% CI: 0.991\u20131.014; p\n                    <jats:italic>non\u2010inferiority<\/jats:italic>\n                    \u2009=\u20090.0006). Reproducibility data demonstrated intra\u2010laboratory agreement of 93.8% (\n                    <jats:italic>\u03ba<\/jats:italic>\n                    \u2009=\u20090.842) and inter\u2010laboratory agreement of 94.4% (\n                    <jats:italic>\u03ba<\/jats:italic>\n                    \u2009=\u20090.856), exceeding the Meijer reproducibility thresholds. Considering the Ct clinical cutoff (\u2264\u200939.0), the Sansure HPV Kit fulfils the established international validation criteria for clinical sensitivity, specificity, and reproducibility for use in primary cervical cancer screening using PreservCyt as storage medium for cervical samples. Consideration of genotype composition, including detection of HPV53 within a pooled channel, is warranted in the context of organised screening programmes.\n                  <\/jats:p>","DOI":"10.1002\/jmv.71106","type":"journal-article","created":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T09:40:02Z","timestamp":1786959602000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Clinical Validation of the Sansure Human Papillomavirus DNA Diagnostic Kit for Use in Primary Cervical Cancer Screening"],"prefix":"10.1002","volume":"98","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1502-1467","authenticated-orcid":false,"given":"Sharonjit Kaur","family":"Dhillon","sequence":"first","affiliation":[{"name":"Unit of Cancer Epidemiology\/Belgian Cancer Centre, Sciensano Brussels Belgium"}],"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\/0000-0001-9381-4158","authenticated-orcid":false,"given":"Davy","family":"Vandenbroeck","sequence":"additional","affiliation":[{"name":"Laboratory of Molecular Diagnostics, Algemeen Medisch Laboratorium (AML) Sonic Healthcare BeNeLux Antwerp Belgium"},{"name":"Applied Molecular Biology Research Group (AMBIOR), Laboratory for Cell Biology and Histology University of Antwerp Antwerp Belgium"},{"name":"National Reference Centre for HPV Brussels Belgium"},{"name":"International Centre for Reproductive Health Ghent University Ghent Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8430-214X","authenticated-orcid":false,"given":"Jean\u2010Luc","family":"Pr\u00e9tet","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Marie et Louis Pasteur, CNRS, Chrono\u2010Environnement Besan\u00e7on France"},{"name":"CHU Besan\u00e7on, Centre National de R\u00e9f\u00e9rence Papillomavirus Besan\u00e7on France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuliya","family":"Tkachenka","sequence":"additional","affiliation":[{"name":"Laboratory of Molecular Diagnostics, Algemeen Medisch Laboratorium (AML) Sonic Healthcare BeNeLux Antwerp Belgium"},{"name":"National Reference Centre for HPV Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2892-4216","authenticated-orcid":false,"given":"Quentin","family":"Lepiller","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Marie et Louis Pasteur, CNRS, Chrono\u2010Environnement Besan\u00e7on France"},{"name":"CHU Besan\u00e7on, Centre National de R\u00e9f\u00e9rence Papillomavirus Besan\u00e7on France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9377-603X","authenticated-orcid":false,"given":"Alice","family":"Baraquin","sequence":"additional","affiliation":[{"name":"CHU Besan\u00e7on, Centre National de R\u00e9f\u00e9rence Papillomavirus Besan\u00e7on France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Killian","family":"Jacquot","sequence":"additional","affiliation":[{"name":"CHU Besan\u00e7on, Centre National de R\u00e9f\u00e9rence Papillomavirus Besan\u00e7on France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6340-3980","authenticated-orcid":false,"given":"Ana Rita","family":"Pereira","sequence":"additional","affiliation":[{"name":"Laboratory of Molecular Diagnostics, Algemeen Medisch 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