{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T16:19:17Z","timestamp":1792685957355,"version":"4.5.0"},"reference-count":38,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2024,4,25]],"date-time":"2024-04-25T00:00:00Z","timestamp":1714003200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100017008","name":"Cancer Research UK Manchester Centre","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100017008","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the sensitivity of human papillomavirus (HPV) tested urine to detect high\u2010grade cervical precancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) using two urine collection devices.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Randomised controlled trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>St Mary's Hospital, Manchester, UK.<\/jats:p><\/jats:sec><jats:sec><jats:title>Population<\/jats:title><jats:p>Colposcopy attendees with abnormal cervical screening; a total of 480 participants were randomised. Matched urine and cervical samples were available for 235 and 230 participants using a first\u2010void urine (FVU)\u2010collection device and standard pot, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Urine was self\u2010collected and mixed with preservative\u2009\u2013\u2009randomised 1:1 to FVU\u2010collection device (Novosanis Colli\u2010pee\u00ae 10\u2009mL with urine conservation medium [UCM]) or standard pot. Matched clinician\u2010collected cervical samples were taken before colposcopy. HPV testing used Roche cobas\u00ae 8800. A questionnaire evaluated urine self\u2010sampling acceptability.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main outcome measures<\/jats:title><jats:p>The primary outcome measured sensitivity of HPV\u2010tested urine (FVU\u2010collection device and standard pot) for CIN2+ detection. Secondary outcomes compared HPV\u2010tested cervical and urine samples for CIN2+ and evaluated the acceptability of urine self\u2010sampling.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Urine HPV test sensitivity for CIN2+ was higher with the FVU\u2010collection device (90.3%, 95% CI 83.7%\u201394.9%, 112\/124) than the standard pot (73.4%, 95% CI 64.7%\u201380.9%, 91\/124, <jats:italic>p<\/jats:italic>\u2009=\u20090.0005). The relative sensitivity of FVU\u2010device\u2010collected urine was 0.92 (95% CI 0.87\u20130.97, <jats:italic>p<\/jats:italic><jats:sub>McN<\/jats:sub>\u2009=\u20090.004) compared with cervical, considering that all women were referred after a positive cervical HPV test. Urine\u2010based sampling was acceptable to colposcopy attendees.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Testing of FVU\u2010device\u2010collected urine for HPV was superior to standard\u2010pot\u2010collected urine in colposcopy attendees and has promising sensitivity for CIN2+ detection. General population HPV testing of FVU\u2010device\u2010collected urine will establish its clinical performance and acceptability as an alternative to routine cervical screening.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1471-0528.17831","type":"journal-article","created":{"date-parts":[[2024,4,25]],"date-time":"2024-04-25T08:03:33Z","timestamp":1714032213000},"page":"1456-1464","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":38,"title":["Urine high\u2010risk human papillomavirus testing as an alternative to routine cervical screening: A comparative diagnostic accuracy study of two urine collection devices using a randomised study design trial"],"prefix":"10.1111","volume":"131","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0193-0053","authenticated-orcid":false,"given":"Jennifer C.","family":"Davies","sequence":"first","affiliation":[{"name":"Gynaecological Oncology Research Group, Division of Cancer Sciences, Faculty of Biology, Medicine and Health University of Manchester  Manchester UK"},{"name":"Department of Obstetrics and Gynaecology, Manchester Academic Health Science Centre, St Mary's Hospital Manchester University NHS Foundation Trust  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Sargent","sequence":"additional","affiliation":[{"name":"Cytology Department, Clinical Sciences Centre, Manchester Academic Health Science Centre Manchester University NHS Foundation Trust  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Pinggera","sequence":"additional","affiliation":[{"name":"Gynaecological Oncology Research Group, Division of Cancer Sciences, Faculty of Biology, Medicine and Health University of Manchester  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Carter","sequence":"additional","affiliation":[{"name":"Gynaecological Oncology Research Group, Division of Cancer Sciences, Faculty of Biology, Medicine and Health University of Manchester  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9477-6090","authenticated-orcid":false,"given":"Clare","family":"Gilham","sequence":"additional","affiliation":[{"name":"Faculty of Epidemiology and Population Health London School of Hygiene and Tropical Medicine  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Sasieni","sequence":"additional","affiliation":[{"name":"Centre for Cancer Prevention, Wolfson Institute of Population Health Queen Mary University of London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0284-8630","authenticated-orcid":false,"given":"Emma J.","family":"Crosbie","sequence":"additional","affiliation":[{"name":"Gynaecological Oncology Research Group, Division of Cancer Sciences, Faculty of Biology, Medicine and Health University of Manchester  Manchester UK"},{"name":"Department of Obstetrics and Gynaecology, Manchester Academic Health Science Centre, St Mary's Hospital Manchester University NHS Foundation Trust  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,4,25]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.2016.290"},{"key":"e_1_2_12_3_1","unstructured":"NHS Digital.Cervical screening programme England \u2013 2022\u20132023. [cited 2023 Nov 23]. Available from:https:\/\/digital.nhs.uk\/data\u2010and\u2010information\/publications\/statistical\/cervical\u2010screening\u2010annual\/england\u20102022\u20102023. Accessed on 24th April 2024."},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/pubmed\/fdad275"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/pon.4126"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g5264"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2021.06.010"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.3390\/molecules26071989"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-025388"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2018.11.008"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01443-19"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2017.05.020"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2022.105271"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-014-2147-2"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.17722"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-068940"},{"key":"e_1_2_12_17_1","unstructured":"Novosanis.Colli\u2010Pee: an innovative solution for non\u2010invasive urine collection and preservation. Available from:https:\/\/novosanis.com\/our\u2010products. Accessed on 24th April 2024."},{"key":"e_1_2_12_18_1","unstructured":"Becton Dickinson and Company.Onclarity\u2122 HPV self collection diluent tubes 2022. Available from:https:\/\/static.bd.com\/documents\/eifu\/ZMG_L012242_EN_B_02.pdf. Accessed on 24th April 2024."},{"key":"e_1_2_12_19_1","article-title":"Cytology versus HPV testing for cervical cancer screening in the general population","volume":"8","author":"Koliopoulos G","year":"2017","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-20-1226"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.14682"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2020-041512"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13690-021-00667-4"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-020-05663-7"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ypmed.2021.106900"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers15061669"},{"key":"e_1_2_12_27_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2022.1003461"},{"key":"e_1_2_12_28_1","doi-asserted-by":"publisher","DOI":"10.3310\/hta20680"},{"key":"e_1_2_12_29_1","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.2011.48"},{"key":"e_1_2_12_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.34358"},{"key":"e_1_2_12_31_1","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-052609"},{"key":"e_1_2_12_32_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.14683"},{"key":"e_1_2_12_33_1","doi-asserted-by":"publisher","DOI":"10.1258\/jms.2009.009073"},{"key":"e_1_2_12_34_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-021-87329-1"},{"key":"e_1_2_12_35_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0235202"},{"key":"e_1_2_12_36_1","doi-asserted-by":"publisher","DOI":"10.1097\/LGT.0000000000000494"},{"key":"e_1_2_12_37_1","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2022.831949"},{"key":"e_1_2_12_38_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.17597"},{"key":"e_1_2_12_39_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clon.2021.06.013"}],"container-title":["BJOG: An International Journal of Obstetrics &amp; Gynaecology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1471-0528.17831","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,16]],"date-time":"2024-10-16T16:13:11Z","timestamp":1729095191000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1111\/1471-0528.17831"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,25]]},"references-count":38,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2024,10]]}},"alternative-id":["10.1111\/1471-0528.17831"],"URL":"https:\/\/doi.org\/10.1111\/1471-0528.17831","archive":["Portico"],"relation":{},"ISSN":["1470-0328","1471-0528"],"issn-type":[{"value":"1470-0328","type":"print"},{"value":"1471-0528","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,25]]},"assertion":[{"value":"2024-01-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-11","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-25","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}