{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T14:57:43Z","timestamp":1793113063674,"version":"4.5.0"},"reference-count":26,"publisher":"BMJ","issue":"4","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2016,2,15]]},"published-print":{"date-parts":[[2016,4]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Papillomavirus Dumfries and Galloway (PaVDaG) assessed the performance of a high-risk human papillomavirus (hrHPV) PCR-based assay to detect high-grade cervical intraepithelial neoplasia (CIN2+) in self-collected vaginal and urine samples.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Women attending routine cervical screening in primary care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>5318 women aged 20\u201360\u2005years provided self-collected random urine and vaginal samples for hrHPV testing and a clinician-collected liquid-based cytology (LBC) sample for cytology and hrHPV testing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>HrHPV testing. All samples were tested for hrHPV using the PCR-based cobas 4800 assay. Colposcopy was offered to women with high-grade or repeated borderline\/low-grade cytological abnormalities; also to those who were LBC negative but hrHPV 16\/18 positive.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>The self-tests' absolute sensitivity and specificity for CIN2+ were assessed on all biospecimens; also, their relative sensitivity and specificity compared with clinician-taken samples. Interlaboratory and intralaboratory performance of the hrHPV assay in self-collected samples was also established.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>HrHPV prevalence was 14.7%, 16.6% and 11.6% in cervical, vaginal and urine samples, respectively. Sensitivity for detecting CIN2+ was 97.7% (95% to 100%), 94.6% (90.7% to 98.5%) and 63.1% (54.6% to 71.7%) for cervical, vaginal and urine hrHPV detection, respectively. The corresponding specificities were 87.3% (86.4% to 88.2%), 85.4% (84.4% to 86.3%) and 89.8% (89.0% to 90.7%). There was a 38% (24% to 57%) higher HPV detection rate in vaginal self-samples from women over 50\u2005years compared with those \u226429\u2005years. Relative sensitivity and specificity of hrHPV positivity for the detection of CIN2+ in vaginal versus cervical samples were 0.97 (0.94 to 1.00) and 0.98 (0.97 to 0.99); urine versus cervical comparisons were 0.53 (0.42 to 0.67) and 1.03 (1.02 to 1.04). The intralaboratory and interlaboratory agreement for hrHPV positivity in self-samples was high (\u03ba values 0.98 (0.96 to 0.99) and 0.94 (0.92 to 0.97) for vaginal samples and 0.95 (0.93 to 0.98) and 0.90 (0.87 to 0.94) for urine samples).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The sensitivity of self-collected vaginal samples for the detection of CIN2+ was similar to that of cervical samples and justifies consideration of this sample for primary screening.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2015-010660","type":"journal-article","created":{"date-parts":[[2016,4,25]],"date-time":"2016-04-25T22:54:48Z","timestamp":1461624888000},"page":"e010660","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":72,"title":["Clinical validation of hrHPV testing on vaginal and urine self-samples in primary cervical screening (cross-sectional results from the Papillomavirus Dumfries and Galloway\u2014PaVDaG study)"],"prefix":"10.1136","volume":"6","author":[{"given":"Grazyna","family":"Stanczuk","sequence":"first","affiliation":[{"name":"Research and Development Support Unit, Dumfries and Galloway Royal Infirmary, Dumfries, UK"},{"name":"Global Health Academy, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0769-081X","authenticated-orcid":false,"given":"Gwendoline","family":"Baxter","sequence":"additional","affiliation":[{"name":"Research and Development Support Unit, Dumfries and Galloway Royal Infirmary, Dumfries, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather","family":"Currie","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, Dumfries and Galloway Royal Infirmary, Dumfries, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Lawrence","sequence":"additional","affiliation":[{"name":"Research and Development Support Unit, Dumfries and Galloway Royal Infirmary, Dumfries, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate","family":"Cuschieri","sequence":"additional","affiliation":[{"name":"Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allan","family":"Wilson","sequence":"additional","affiliation":[{"name":"Department of Pathology, Monklands Hospital, Airdrie, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Arbyn","sequence":"additional","affiliation":[{"name":"Unit of Cancer Epidemiology\/Belgian Cancer Centre, Scientific Institute of Public Health, Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2016,4,25]]},"reference":[{"key":"2025121401143112000_6.4.e010660.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2012.06.095"},{"key":"2025121401143112000_6.4.e010660.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62218-7"},{"key":"2025121401143112000_6.4.e010660.3","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.24010"},{"key":"2025121401143112000_6.4.e010660.4","doi-asserted-by":"crossref","first-page":"817","DOI":"10.1016\/j.cmi.2015.04.015","article-title":"Which high-risk HPV assays fulfil criteria for use in primary cervical cancer screening?","volume":"211","author":"Arbyn","year":"2015","journal-title":"Clin Microbiol Infect"},{"key":"2025121401143112000_6.4.e010660.5","doi-asserted-by":"crossref","first-page":"2375","DOI":"10.1016\/j.ejca.2015.07.006","article-title":"Reaching women who do not participate in the regular cervical cancer screening program by offering self-sampling kits: a systematic review and meta-analysis of randomised trials","volume":"51","author":"Verdoodt","year":"2015","journal-title":"Eur J Cancer"},{"key":"2025121401143112000_6.4.e010660.6","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c1040"},{"key":"2025121401143112000_6.4.e010660.7","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-14-1417"},{"key":"2025121401143112000_6.4.e010660.8","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.27790"},{"key":"2025121401143112000_6.4.e010660.9","doi-asserted-by":"crossref","first-page":"1060","DOI":"10.1186\/1471-2458-14-1060","article-title":"Women's intentions to self-collect samples for human papillomavirus testing in an organized cervical screening program","volume":"14","author":"Smith","year":"2014","journal-title":"BMC Public Health"},{"key":"2025121401143112000_6.4.e010660.10","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.24774"},{"key":"2025121401143112000_6.4.e010660.11","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(13)70570-9"},{"key":"2025121401143112000_6.4.e010660.12","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.26202"},{"key":"2025121401143112000_6.4.e010660.13","first-page":"513","article-title":"Comparison of self-collected vaginal, vulvar and urine samples with physician-collected cervical samples for human papillomavirus testing to detect high-grade squamous intraepithelial lesions","volume":"163","author":"Sellors","year":"2000","journal-title":"CMAJ"},{"issue":"Suppl 1","key":"2025121401143112000_6.4.e010660.14","doi-asserted-by":"crossref","first-page":"S12","DOI":"10.1016\/S1386-6532(09)70069-1","article-title":"Evaluation of a new strategy for cervical cancer screening in women who do not access to pap smear screening in West Brittany, using a urine test for human papillomavirus (HPV) detection on a large scale platform combining EasyMag extractor and real-time PCR LightCycler system (the PAPU29 Phase 1 study)","volume":"46","author":"Payan","year":"2009","journal-title":"J Clin Virol"},{"key":"2025121401143112000_6.4.e010660.15","doi-asserted-by":"crossref","first-page":"627","DOI":"10.1007\/s10096-011-1358-z","article-title":"Detection of human papillomavirus DNA in urine. A review of the literature","volume":"31","author":"Vorsters","year":"2011","journal-title":"Eur J Clin Microbiol Infect Dis"},{"key":"2025121401143112000_6.4.e010660.16","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g5264"},{"key":"2025121401143112000_6.4.e010660.17","doi-asserted-by":"publisher","DOI":"10.1136\/jclinpath-2014-202851"},{"key":"2025121401143112000_6.4.e010660.18","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2009.10.007"},{"key":"2025121401143112000_6.4.e010660.19","unstructured":"Smith JHF , Patnick J , eds. Achievable standards, benchmarks for reporting and criteria for conducting cervical cytopathology. 2nd edn. Sheffield: NHS Cancers Screening Programmes, 2013. http:\/\/www.cancerscreening.nhs.uk\/cervical\/publications\/nhscsp01.html"},{"key":"2025121401143112000_6.4.e010660.20","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1213"},{"key":"2025121401143112000_6.4.e010660.21","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01366-15"},{"key":"2025121401143112000_6.4.e010660.22","doi-asserted-by":"crossref","first-page":"1211","DOI":"10.1016\/S0895-4356(97)00122-4","article-title":"Comparing dichotomous screening tests when individuals negative on both tests are not verified","volume":"51","author":"Chock","year":"1997","journal-title":"J Clin Epidemiol"},{"key":"2025121401143112000_6.4.e010660.23","doi-asserted-by":"crossref","first-page":"672","DOI":"10.1093\/oxfordjournals.aje.a114580","article-title":"Comparing new and old screening tests when reference procedure cannot be performed on all screenees. Example of automated cytometry for early detection of cervical cancer","volume":"125","author":"Schatzkin","year":"1987","journal-title":"Am J Epidemiol"},{"key":"2025121401143112000_6.4.e010660.24","doi-asserted-by":"crossref","first-page":"295","DOI":"10.1309\/AJCPGW1V2BBWMOCX","article-title":"The interplay of age stratification and HPV testing on the predictive value of ASC-US cytology. Results from the ATHENA HPV study","volume":"137","author":"Stoler","year":"2012","journal-title":"Am J Natl Clin Pathol"},{"key":"2025121401143112000_6.4.e010660.25","doi-asserted-by":"crossref","first-page":"117","DOI":"10.5468\/ogs.2015.58.2.117","article-title":"Impact of age on the false negative rate of human papillomavirus DNA test in patients with atypical squamous cells of undetermined significance","volume":"58","author":"Won","year":"2015","journal-title":"Obstet Gynecol Sci"},{"key":"2025121401143112000_6.4.e010660.26","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1097\/LGT.0b013e3182503402","article-title":"The correlation between HPV positivity and abnormal cervical cytology differs by age among peri-menopausal women","volume":"17","author":"Rositch","year":"2013","journal-title":"J Low Genital Tract Dis"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2015-010660","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T09:14:41Z","timestamp":1765703681000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2015-010660"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,4]]},"references-count":26,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2016,4,25]]},"published-print":{"date-parts":[[2016,4]]}},"alternative-id":["10.1136\/bmjopen-2015-010660"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2015-010660","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,4]]}}}