{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T04:20:38Z","timestamp":1772943638217,"version":"3.50.1"},"reference-count":28,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","award":["5\\u2009\\u00D7\\u20091000"],"award-info":[{"award-number":["5\\u2009\\u00D7\\u20091000"]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100017412","name":"Becton Dickinson and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017412","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Clinical Virology"],"published-print":{"date-parts":[[2025,10]]},"DOI":"10.1016\/j.jcv.2025.105846","type":"journal-article","created":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T17:44:55Z","timestamp":1753724695000},"page":"105846","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Clinical performance of the BD Onclarity\u2122 HPV extended genotyping assay for anal cancer screening: a prospective pilot study"],"prefix":"10.1016","volume":"180","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6909-1228","authenticated-orcid":false,"given":"Anna Daniela","family":"Iacobone","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabio","family":"Bottari","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Davide","family":"Radice","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvia","family":"Martella","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pietro","family":"Soru","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristian","family":"Mauro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiara","family":"Scacchi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clementina","family":"Di Tonno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rita","family":"Passerini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Trovato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.jcv.2025.105846_bib1","unstructured":"National Cancer Institute, Cancer Stat Facts: Anal Cancer, SEER. \u3008https:\/\/seer.cancer.gov\/statfacts\/html\/anus.html\u3009 (accessed February 7, 2025)."},{"key":"10.1016\/j.jcv.2025.105846_bib2","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1002\/ijc.33185","article-title":"A meta-analysis of anal cancer incidence by risk group: toward a unified anal cancer risk scale","volume":"148","author":"Clifford","year":"2021","journal-title":"Int. J. Cancer"},{"key":"10.1016\/j.jcv.2025.105846_bib3","doi-asserted-by":"crossref","first-page":"1694","DOI":"10.1002\/ijc.34850","article-title":"International Anal Neoplasia Society's consensus guidelines for anal cancer screening","volume":"154","author":"Stier","year":"2024","journal-title":"Int. J. Cancer"},{"key":"10.1016\/j.jcv.2025.105846_bib4","doi-asserted-by":"crossref","first-page":"198","DOI":"10.1016\/S1473-3099(17)30653-9","article-title":"Human papillomavirus types from infection to cancer in the anus, according to sex and HIV status: a systematic review and meta-analysis","volume":"18","author":"Lin","year":"2018","journal-title":"Lancet Infect. Dis."},{"key":"10.1016\/j.jcv.2025.105846_bib5","doi-asserted-by":"crossref","first-page":"447","DOI":"10.1002\/cncy.22018","article-title":"Strategies for screening and early detection of anal cancers: a narrative and systematic review and meta-analysis of cytology, HPV testing, and other biomarkers","volume":"126","author":"Clarke","year":"2018","journal-title":"Cancer Cytopathol."},{"key":"10.1016\/j.jcv.2025.105846_bib6","doi-asserted-by":"crossref","first-page":"1889","DOI":"10.1002\/ijc.34199","article-title":"A systematic review and meta-analysis of cytology and HPV-related biomarkers for anal cancer screening among different risk groups","volume":"151","author":"Clarke","year":"2022","journal-title":"Int. J. Cancer"},{"key":"10.1016\/j.jcv.2025.105846_bib7","doi-asserted-by":"crossref","DOI":"10.1016\/j.jcv.2024.105671","article-title":"2023 Global inventory of commercial molecular tests for human papillomaviruses (HPV)","volume":"172","author":"Poljak","year":"2024","journal-title":"J. Clin. Virol."},{"key":"10.1016\/j.jcv.2025.105846_bib8","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1016\/j.soc.2016.07.013","article-title":"Pathology of anal cancer","volume":"26","author":"Hoff","year":"2017","journal-title":"Surg. Oncol. Clin. N. Am."},{"key":"10.1016\/j.jcv.2025.105846_bib9","doi-asserted-by":"crossref","first-page":"565","DOI":"10.1080\/14737159.2019.1622415","article-title":"Profile of the BD HPV OnclarityTM assay","volume":"19","author":"Bottari","year":"2019","journal-title":"Expert Rev. Mol. Diagn."},{"key":"10.1016\/j.jcv.2025.105846_bib10","doi-asserted-by":"crossref","DOI":"10.1016\/j.eclinm.2023.102128","article-title":"DNA high-risk HPV, mRNA HPV and P16 tests for diagnosis of anal cancer and precursor lesions: a systematic review and meta-analysis","volume":"62","author":"Macedo","year":"2023","journal-title":"eClinicalMedicine"},{"key":"10.1016\/j.jcv.2025.105846_bib11","doi-asserted-by":"crossref","DOI":"10.1093\/ofid\/ofae735","article-title":"Using anal cytology and human papillomavirus DNA and E6\/E7 mRNA detection to optimize high-resolution anoscopy referrals in men who have sex with men with HIV","volume":"12","author":"Silva-Klug","year":"2024","journal-title":"Open Forum Infect. Dis."},{"key":"10.1016\/j.jcv.2025.105846_bib12","doi-asserted-by":"crossref","first-page":"1083","DOI":"10.1016\/j.cmi.2021.04.031","article-title":"2020 List of human papillomavirus assays suitable for primary cervical cancer screening","volume":"27","author":"Arbyn","year":"2021","journal-title":"Clin. Microbiol. Infect."},{"key":"10.1016\/j.jcv.2025.105846_bib13","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1016\/j.pvr.2016.01.003","article-title":"Clinical and analytical performance of the BD Onclarity HPV assay for detection of CIN2+ lesions on SurePath samples","volume":"2","author":"Ejegod","year":"2016","journal-title":"Papillomavirus Res."},{"key":"10.1016\/j.jcv.2025.105846_bib14","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1097\/LGT.0000000000000441","article-title":"Onclarity human papillomavirus extended genotyping in the management of cervical intraepithelial neoplasia 2+ lesions","volume":"23","author":"Bottari","year":"2019","journal-title":"J. Low Genit. Trac. Dis."},{"key":"10.1016\/j.jcv.2025.105846_bib15","doi-asserted-by":"crossref","first-page":"2359","DOI":"10.3390\/diagnostics12102359","article-title":"HPV tests comparison in the detection and follow-up after surgical treatment of CIN2+ lesions","volume":"12","author":"Bottari","year":"2022","journal-title":"Diagnostics"},{"key":"10.1016\/j.jcv.2025.105846_bib16","doi-asserted-by":"crossref","first-page":"452","DOI":"10.1097\/AOG.0000000000003409","article-title":"Human papillomavirus genotyping compared with a qualitative high-risk human papillomavirus test after treatment of high-grade cervical intraepithelial neoplasia: a systematic review","volume":"134","author":"Bottari","year":"2019","journal-title":"Obstet. Gynecol."},{"key":"10.1016\/j.jcv.2025.105846_bib17","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1097\/LGT.0000000000000573","article-title":"Human papillomavirus same genotype persistence and risk: a systematic review","volume":"25","author":"Bonde","year":"2021","journal-title":"J. Low Genit. Trac. Dis."},{"key":"10.1016\/j.jcv.2025.105846_bib18","doi-asserted-by":"crossref","DOI":"10.1128\/spectrum.02872-23","article-title":"Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples","volume":"12","author":"Martinelli","year":"2024","journal-title":"Microbiol. Spectr."},{"key":"10.1016\/j.jcv.2025.105846_bib19","article-title":"Clinical validation of the BD OnclarityT HPV assay using a noninferiority test","author":"Ejegod","year":"2014","journal-title":"J. Med. Microbiol. Diagn."},{"key":"10.1016\/j.jcv.2025.105846_bib20","doi-asserted-by":"crossref","DOI":"10.1128\/JCM.01366-15","article-title":"Clinical and analytical performance of the Onclarity HPV assay using the VALGENT framework","volume":"53","author":"Cuschieri","year":"2015","journal-title":"J. Clin. Microbiol."},{"key":"10.1016\/j.jcv.2025.105846_bib21","doi-asserted-by":"crossref","DOI":"10.1128\/JCM.00508-16","article-title":"The BD onclarity HPV assay on SurePath collected samples meets the international guidelines for human papillomavirus test requirements for cervical screening","volume":"54","author":"Ejegod","year":"2016","journal-title":"J. Clin. Microbiol."},{"key":"10.1016\/j.jcv.2025.105846_bib22","doi-asserted-by":"crossref","DOI":"10.1128\/JCM.01518-19","article-title":"Clinical and analytical performance of the BD onclarity HPV Assay with SurePath screening samples from the Danish cervical screening program using the VALGENT framework","volume":"58","author":"Bonde","year":"2020","journal-title":"J. Clin. Microbiol."},{"key":"10.1016\/j.jcv.2025.105846_bib23","doi-asserted-by":"crossref","first-page":"259","DOI":"10.1097\/LGT.0000000000000487","article-title":"Distribution of high-risk human papillomavirus genotypes and multiple infections in preneoplastic and neoplastic cervical lesions of unvaccinated women: a cross-sectional study","volume":"23","author":"Iacobone","year":"2019","journal-title":"J. Low Genit. Trac. Dis."},{"key":"10.1016\/j.jcv.2025.105846_bib24","doi-asserted-by":"crossref","first-page":"e531","DOI":"10.1016\/S2352-3018(21)00108-9","article-title":"Epidemiology of anal human papillomavirus infection and high-grade squamous intraepithelial lesions in 29\u2009900 men according to HIV status, sexuality, and age: a collaborative pooled analysis of 64 studies","volume":"8","author":"Wei","year":"2021","journal-title":"Lancet HIV"},{"key":"10.1016\/j.jcv.2025.105846_bib25","doi-asserted-by":"crossref","first-page":"216","DOI":"10.1097\/LGT.0000000000000613","article-title":"Onclarity performance in human papillomavirus DNA detection in formalin-fixed paraffin-embedded cervical samples","volume":"25","author":"Bottari","year":"2021","journal-title":"J. Low Genit. Trac. Dis."},{"key":"10.1016\/j.jcv.2025.105846_bib26","doi-asserted-by":"crossref","first-page":"501","DOI":"10.1093\/jnci\/djx225","article-title":"Relative performance of HPV and cytology components of cotesting in cervical screening","volume":"110","author":"Schiffman","year":"2018","journal-title":"J. Natl. Cancer Int."},{"key":"10.1016\/j.jcv.2025.105846_bib27","doi-asserted-by":"crossref","first-page":"130","DOI":"10.1093\/ajcp\/aqab103","article-title":"The potential impact of high-risk human papillomavirus-negative cervical intraepithelial neoplasia 2+ on primary human papillomavirus screening","volume":"157","author":"Iacobone","year":"2022","journal-title":"Am. J. Clin. Pathol."},{"key":"10.1016\/j.jcv.2025.105846_bib28","doi-asserted-by":"crossref","first-page":"3664","DOI":"10.3390\/cancers13153664","article-title":"Human papillomavirus same genotype persistence and risk of cervical intraepithelial neoplasia2+ recurrence","volume":"13","author":"Iacobone","year":"2021","journal-title":"Cancers"}],"container-title":["Journal of Clinical Virology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1386653225000885?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1386653225000885?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,3,7]],"date-time":"2026-03-07T12:46:25Z","timestamp":1772887585000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1386653225000885"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10]]},"references-count":28,"alternative-id":["S1386653225000885"],"URL":"https:\/\/doi.org\/10.1016\/j.jcv.2025.105846","relation":{},"ISSN":["1386-6532"],"issn-type":[{"value":"1386-6532","type":"print"}],"subject":[],"published":{"date-parts":[[2025,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Clinical performance of the BD Onclarity\u2122 HPV extended genotyping assay for anal cancer screening: a prospective pilot study","name":"articletitle","label":"Article Title"},{"value":"Journal of Clinical Virology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jcv.2025.105846","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"105846"}}