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This study reports on the performance of Abbott Alinity m HR HPV on urine, self\u2010collected at home using a new generation first\u2010void urination device that is suitable for postal delivery (Novosanis Colli\u2010Pee Small Volumes). First\u2010void urine and paired cervical samples from 297 females attending colposcopy (age 25\u201365, NCT04530201) were analysed for the presence of Human Papillomavirus (HPV) DNA. Cervical disease was confirmed by colposcopy and\/or histology. HPV testing on first\u2010void urine was less sensitive for high\u2010grade cervical intraepithelial neoplasia (CIN2\u2009+; ratio 0.91; 95% CI: 0.83\u20130.99), though equally specific (&lt;\u2009CIN2; ratio 1.04; 95% CI: 0.92\u20131.19) compared to cervical samples at the manufacturer established cut\u2010off for cervical samples. Adjusting the cut\u2010off for first\u2010void urine improved sensitivity for CIN2+ (ratio 0.96; 95% CI: 0.90\u20131.03), whilst maintaining equal specificity compared to cervical samples (ratio 1.00; 95% CI: 0.88\u20131.14). Cohen's kappa agreements of HPV outcomes between sample pairs were good to excellent at both cut\u2010offs (range: 0.64\u20130.85). Using the HPV test's adjusted cutoff for first\u2010void urine, no difference in clinical sensitivity or specificity was observed between first\u2010void urine and cervical samples. These data highlight the importance of evaluating self\u2010sample\u2010specific cut\u2010offs for HPV assays, previously validated on cervical samples.<\/jats:p>","DOI":"10.1002\/jmv.70254","type":"journal-article","created":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T12:40:46Z","timestamp":1740141646000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Clinical and Analytical Evaluation of the Abbott Alinity m HR HPV Assay in a New Generation First\u2010Void Urine Collector"],"prefix":"10.1002","volume":"97","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1842-7478","authenticated-orcid":false,"given":"Severien","family":"Van Keer","sequence":"first","affiliation":[{"name":"Centre for the Evaluation of Vaccination (CEV), Vaccine &amp; Infectious Disease Institute (VAXINFECTIO) University of Antwerp Edegem Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7484-0956","authenticated-orcid":false,"given":"Laura","family":"T\u00e9blick","sequence":"additional","affiliation":[{"name":"Centre for the Evaluation of Vaccination (CEV), Vaccine &amp; 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