{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T15:02:43Z","timestamp":1780671763376,"version":"3.54.1"},"reference-count":40,"publisher":"American Association for Cancer Research (AACR)","issue":"7","funder":[{"name":"Gouvernement du Canada | Canadian Institutes of Health ResearchGouvernement du Canada | Canadian Institutes of Health Research (CIHR)","award":["FDN-143347"],"award-info":[{"award-number":["FDN-143347"]}]}],"content-domain":{"domain":["aacrjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2019,7,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background:<\/jats:title>\n                  <jats:p>Self-sampling has become an attractive proposition now that human papillomavirus (HPV) primary testing is being incorporated into cervical cancer screening programs worldwide. We compared predictive values of HPV testing based on self- and physician-collected samples, and cytology, in detecting high-grade cervical intraepithelial neoplasia (CIN).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods:<\/jats:title>\n                  <jats:p>The Cervical And Self-Sample In Screening (CASSIS) study enrolled 1,217 women ages 16\u201370 years prior to scheduled colposcopies. Vaginal specimens were self-collected using the validated HerSwab device. Cervical specimens were collected by gynecologists. Specimens were tested for presence of high-risk HPV (hrHPV) by the Cobas 4800 HPV test. We estimated positive predictive values (PPV) and negative predictive values (NPV) and 95% confidence intervals (CI) for a subset of women (n = 700) who underwent cervical biopsy and cytology at the actual CASSIS visit.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results:<\/jats:title>\n                  <jats:p>hrHPV was detected in 329 women (47%) with HerSwab and in 327 (46.7%) with physician sampling. Respective values for HPV16\/18 were 119 (17%) and 121 (17.3%). On histology, 134 women had CIN1, 49 had CIN2, 48 had CIN3, 5 had CIN2\/CIN3, and 3 had cancers. PPVs for CIN2+ of any hrHPV were 28% (95% CI, 23.2\u201333.1) and 29.7% (95% CI, 24.8\u201334.9) for HerSwab and physician samples, respectively. Corresponding values for HPV16\/18 were 43.7% (95% CI, 34.6\u201353.1) and 43.8% (95% CI, 34.8\u201353.1). PPV of cytology (ASC-US+) was 26.6% (95% CI, 21.6\u201332.0). Corresponding NPVs (same order as PPVs) were 96.4% (95% CI, 93.9\u201398.1), 97.8% (95% CI, 95.6\u201399), 90.9% (95% CI, 88.2\u201393.1), 91% (95% CI, 88.4\u201393.2), and 94.7% (95% CI, 91.8\u201396.8).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions:<\/jats:title>\n                  <jats:p>Our results confirm that HPV self-sampling has comparable performance with a physician-collected sample in detecting cervical lesions.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Impact:<\/jats:title>\n                  <jats:p>HPV self-sampling has the potential to increase coverage in cervical cancer screening.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1158\/1055-9965.epi-18-1338","type":"journal-article","created":{"date-parts":[[2019,4,23]],"date-time":"2019-04-23T19:46:08Z","timestamp":1556048768000},"page":"1134-1140","update-policy":"https:\/\/doi.org\/10.1158\/crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Predictive Value of HPV Testing in Self-collected and Clinician-Collected Samples Compared with Cytology in Detecting High-grade Cervical Lesions"],"prefix":"10.1158","volume":"28","author":[{"given":"Mariam","family":"El-Zein","sequence":"first","affiliation":[{"name":"1Division of Cancer Epidemiology, McGill University, Montreal, Canada."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheila","family":"Bouten","sequence":"additional","affiliation":[{"name":"1Division of Cancer Epidemiology, McGill University, Montreal, Canada."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1172-363X","authenticated-orcid":false,"given":"Karolina","family":"Louvanto","sequence":"additional","affiliation":[{"name":"1Division of Cancer Epidemiology, McGill University, Montreal, Canada."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Gilbert","sequence":"additional","affiliation":[{"name":"2Gynecologic Cancer Service, McGill University Health Centre - Glen Site Cedars Cancer Centre, Montreal, Canada."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter H.","family":"Gotlieb","sequence":"additional","affiliation":[{"name":"3Division of Gynecologic Oncology and Colposcopy, McGill University - Jewish General Hospital, Montreal, Canada."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Hemmings","sequence":"additional","affiliation":[{"name":"4Department of Obstetrics and Gynecology, McGill University Health Centre - St. Mary's Hospital Centre, Montreal, Canada."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcel A.","family":"Behr","sequence":"additional","affiliation":[{"name":"5Department of Microbiology, McGill University Health Centre, Montreal, Canada."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4409-8084","authenticated-orcid":false,"given":"Eduardo L.","family":"Franco","sequence":"additional","affiliation":[{"name":"1Division of Cancer Epidemiology, McGill University, Montreal, Canada."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the CASSIS Study Group*","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1086","published-online":{"date-parts":[[2019,7,1]]},"reference":[{"key":"2022060922432985500_bib1","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1016\/j.ypmed.2017.05.021","article-title":"High-risk human papillomavirus detection in self-sampling compared to physician-taken smear in a responder population of the Dutch cervical screening: results of the VERA study","volume":"101","author":"Ketelaars","year":"2017","journal-title":"Prev Med"},{"key":"2022060922432985500_bib2","doi-asserted-by":"crossref","first-page":"e27","DOI":"10.3747\/co.25.3915","article-title":"Self-collection for under-screened women in a National Cervical Screening Program: pilot study","volume":"25","author":"Saville","year":"2018","journal-title":"Curr Oncol"},{"key":"2022060922432985500_bib3","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1016\/j.cct.2017.11.004","article-title":"Rationale and design of the HOME trial: a pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake and effectiveness in a U.S. healthcare system","volume":"64","author":"Winer","year":"2018","journal-title":"Contemp Clin Trials"},{"key":"2022060922432985500_bib4","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1177\/0969141316639346","article-title":"Offering self-sampling to cervical screening non-attenders in primary care","volume":"24","author":"Lim","year":"2017","journal-title":"J Med Screen"},{"key":"2022060922432985500_bib5","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1371\/journal.pone.0151978","article-title":"Self-sampling for human papillomavirus testing among non-attenders increases attendance to the Norwegian cervical cancer screening programme","volume":"11","author":"Enerly","year":"2016","journal-title":"PLoS One"},{"key":"2022060922432985500_bib6","doi-asserted-by":"crossref","first-page":"835","DOI":"10.1186\/s12885-016-2859-z","article-title":"Study protocol of the CHOiCE trial: a three-armed, randomized, controlled trial of home-based HPV self-sampling for non-participants in an organized cervical cancer screening program","volume":"16","author":"Tranberg","year":"2016","journal-title":"BMC Cancer"},{"key":"2022060922432985500_bib7","doi-asserted-by":"crossref","first-page":"1382","DOI":"10.1038\/bjc.2017.111","article-title":"Self-sampling to improve cervical cancer screening coverage in Switzerland: a randomised controlled trial","volume":"116","author":"Viviano","year":"2017","journal-title":"Br J Cancer"},{"key":"2022060922432985500_bib8","doi-asserted-by":"crossref","first-page":"77","DOI":"10.3389\/fpubh.2018.00077","article-title":"Self-Sampling for human papillomavirus testing: increased cervical cancer screening participation and incorporation in international screening programs","volume":"9","author":"Gupta","year":"2018","journal-title":"Front Public Health"},{"key":"2022060922432985500_bib9","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1016\/j.ypmed.2016.11.029","article-title":"Introduction of molecular HPV testing as the primary technology in cervical cancer screening: acting on evidence to change the current paradigm","volume":"98","author":"Tota","year":"2017","journal-title":"Prev Med"},{"key":"2022060922432985500_bib10","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.3747\/co.25.3969","article-title":"Self-sampling for cervical cancer screening: empowering women to lead a paradigm change in cancer control","volume":"25","author":"Franco","year":"2018","journal-title":"Curr Oncol"},{"key":"2022060922432985500_bib11","doi-asserted-by":"crossref","first-page":"530","DOI":"10.1016\/j.ygyno.2007.01.023","article-title":"Are self-collected samples comparable to physician-collected cervical specimens for human papillomavirus DNA testing? A systematic review and meta-analysis","volume":"105","author":"Petignat","year":"2007","journal-title":"Gynecol Oncol"},{"key":"2022060922432985500_bib12","first-page":"95","article-title":"Evaluation of self-collected cervicovaginal cell samples for human papillomavirus testing by polymerase chain reaction","volume":"10","author":"Gravitt","year":"2001","journal-title":"Cancer Epidemiol Biomarkers Prev"},{"key":"2022060922432985500_bib13","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1136\/sti.2004.011858","article-title":"Diagnostic accuracy of self collected vaginal specimens for human papillomavirus compared to clinician collected human papillomavirus specimens: a meta-analysis","volume":"81","author":"Ogilvie","year":"2005","journal-title":"Sex Transm Infect"},{"key":"2022060922432985500_bib14","first-page":"817","article-title":"Self-Collected samples for testing of oncogenic human papillomavirus: a systematic review","volume":"29","author":"Stewart","year":"2007","journal-title":"J Obstet Gynaecol"},{"key":"2022060922432985500_bib15","doi-asserted-by":"crossref","first-page":"1734","DOI":"10.1128\/JCM.00529-16","article-title":"Field evaluation of Xpert HPV point-of-care test for detection of human papillomavirus infection by use of self-collected vaginal and clinician-collected cervical specimens","volume":"54","author":"Toliman","year":"2016","journal-title":"J Clin Microbiol"},{"key":"2022060922432985500_bib16","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1186\/s12905-017-0448-1","article-title":"Self-collected vaginal sampling for the detection of genital human papillomavirus (HPV) using careHPV among Ghanaian women","volume":"17","author":"Obiri-Yeboah","year":"2017","journal-title":"BMC Womens Health"},{"key":"2022060922432985500_bib17","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1016\/j.jcv.2016.06.016","article-title":"Direct comparison of two vaginal self-sampling devices for the detection of human papillomavirus infections","volume":"82","author":"Jentschke","year":"2016","journal-title":"J Clin Virol"},{"key":"2022060922432985500_bib18","doi-asserted-by":"crossref","first-page":"1612","DOI":"10.1093\/jnci\/djp367","article-title":"Age-specific evaluation of primary human papillomavirus screening vs conventional cytology in a randomized setting","volume":"101","author":"Leinonen","year":"2009","journal-title":"J Natl Cancer Inst"},{"key":"2022060922432985500_bib19","doi-asserted-by":"crossref","first-page":"172","DOI":"10.1016\/S1470-2045(13)70570-9","article-title":"Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis","volume":"15","author":"Arbyn","year":"2014","journal-title":"Lancet Oncol"},{"key":"2022060922432985500_bib20","doi-asserted-by":"crossref","first-page":"769","DOI":"10.1158\/1055-9965.EPI-14-1417","article-title":"Offering self-sampling kits for HPV testing to reach women who do not attend in the regular cervical cancer screening program","volume":"24","author":"Arbyn","year":"2015","journal-title":"Cancer Epidemiol Biomarkers Prev"},{"key":"2022060922432985500_bib21","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1016\/j.ygyno.2018.04.004","article-title":"Validation of a new HPV self-sampling device for cervical cancer screening: the Cervical And Self-Sample In Screening (CASSIS) study","volume":"149","author":"El-Zein","year":"2018","journal-title":"Gynecol Oncol"},{"key":"2022060922432985500_bib22","first-page":"k4823","article-title":"Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses","volume":"363","author":"Arbyn","year":"2018","journal-title":"BMJ Open"},{"key":"2022060922432985500_bib23","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1016\/j.jcv.2011.05.006","article-title":"Type-specific detection of high-risk human papillomavirus (HPV) in self-sampled cervicovaginal cells applied to FTA elute cartridge","volume":"51","author":"Gustavsson","year":"2011","journal-title":"J Clin Virol"},{"key":"2022060922432985500_bib24","doi-asserted-by":"crossref","first-page":"576","DOI":"10.1097\/IGC.0000000000000084","article-title":"A multicountry evaluation of care HPV testing, visual inspection with acetic acid, and Papanicolaou testing for the detection of cervical cancer","volume":"24","author":"Jeronimo","year":"2014","journal-title":"Int J Gynecol Cancer"},{"key":"2022060922432985500_bib25","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"},{"key":"2022060922432985500_bib26","doi-asserted-by":"crossref","first-page":"365","DOI":"10.1097\/OLQ.0000000000000125","article-title":"Evaluation of a new APTIMA specimen collection and transportation kit for high-risk human papillomavirus E6\/E7 messenger RNA in cervical and vaginal samples","volume":"41","author":"Chernesky","year":"2014","journal-title":"Sex Transm Dis"},{"key":"2022060922432985500_bib27","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1136\/sextrans-2016-052609","article-title":"The acceptability of self-sampled screening for HPV DNA: a systematic review and meta-analysis","volume":"93","author":"Nelson","year":"2017","journal-title":"Sex Transm Infect"},{"key":"2022060922432985500_bib28","first-page":"597","article-title":"Emerging role of HPV self-sampling in cervical cancer screening for hard-To-reach women","volume":"63","author":"Madzima","year":"2017","journal-title":"Can Fam Physician"},{"key":"2022060922432985500_bib29","doi-asserted-by":"crossref","first-page":"611","DOI":"10.1097\/MLR.0b013e3181d6886f","article-title":"Low rates of cervical cancer screening among urban immigrants: a population-based study in Ontario, Canada","volume":"48","author":"Lofters","year":"2010","journal-title":"Med Care"},{"key":"2022060922432985500_bib30","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1046\/j.1365-2303.2002.00397.x","article-title":"Bethesda 2001","volume":"13","author":"Smith","year":"2002","journal-title":"Cytopathology"},{"key":"2022060922432985500_bib31","doi-asserted-by":"crossref","first-page":"F88","DOI":"10.1016\/j.vaccine.2012.06.095","article-title":"Evidence regarding human papillomavirus testing in secondary prevention of cervical cancer","volume":"30","author":"Arbyn","year":"2012","journal-title":"Vaccine"},{"key":"2022060922432985500_bib32","doi-asserted-by":"crossref","first-page":"896","DOI":"10.1038\/bjc.2017.485","article-title":"Randomised study shows that repeated self-sampling and HPV test has more than twofold higher detection rate of women with CIN2+ histology than Pap smear cytology","volume":"118","author":"Gustavsson","year":"2018","journal-title":"Br J Cancer"},{"key":"2022060922432985500_bib33","doi-asserted-by":"crossref","first-page":"138","DOI":"10.1038\/bjc.2017.371","article-title":"High-grade cervical intraepithelial neoplasia in human papillomavirus self-sampling of screening non-attenders","volume":"118","author":"Lam","year":"2018","journal-title":"Br J Cancer"},{"key":"2022060922432985500_bib34","doi-asserted-by":"crossref","first-page":"440","DOI":"10.1002\/ijc.30454","article-title":"HPV for cervical cancer screening (HPV FOCAL): complete round 1 results of a randomized trial comparing HPV-based primary screening to liquid-based cytology for cervical cancer","volume":"140","author":"Ogilvie","year":"2016","journal-title":"Int J Cancer"},{"key":"2022060922432985500_bib35","doi-asserted-by":"crossref","first-page":"524","DOI":"10.1016\/S0140-6736(13)62218-7","article-title":"Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials","volume":"383","author":"Ronco","year":"2014","journal-title":"Lancet"},{"key":"2022060922432985500_bib36","doi-asserted-by":"crossref","first-page":"710","DOI":"10.1111\/jog.13258","article-title":"Accuracy of self-collected human papillomavirus samples from Japanese women with abnormal cervical cytology","volume":"43","author":"Aiko","year":"2017","journal-title":"J Obstet Gynaecol Res"},{"key":"2022060922432985500_bib37","doi-asserted-by":"crossref","first-page":"1091","DOI":"10.1002\/cam4.1060","article-title":"A cross-sectional study on HPV testing with type 16\/18 genotyping for cervical cancer screening in 11,064 Chinese women","volume":"6","author":"Wu","year":"2017","journal-title":"Cancer Med"},{"key":"2022060922432985500_bib38","doi-asserted-by":"crossref","first-page":"691","DOI":"10.1002\/ijc.30090","article-title":"The clinical value of HPV genotyping in triage of women with high-risk-HPV-positive self-samples","volume":"139","author":"Ebisch","year":"2016","journal-title":"Int J Cancer"},{"key":"2022060922432985500_bib39","first-page":"245","article-title":"Performance measures related to colposcopy for Canadian cervical cancer screening programs: identifying areas for improvement","volume":"37","author":"Decker","year":"2015","journal-title":"J Obstet Gynaecol"},{"key":"2022060922432985500_bib40","doi-asserted-by":"crossref","first-page":"13","DOI":"10.3747\/co.25.3845","article-title":"HPV self-sampling: a promising approach to reduce cervical cancer screening disparities in Canada","volume":"25","author":"Vahabi","year":"2018","journal-title":"Curr Oncol"}],"container-title":["Cancer Epidemiology, Biomarkers &amp; Prevention"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/aacrjournals.org\/cebp\/article-pdf\/28\/7\/1134\/2286681\/1134.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/aacrjournals.org\/cebp\/article-pdf\/28\/7\/1134\/2286681\/1134.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,6,10]],"date-time":"2022-06-10T03:25:43Z","timestamp":1654831543000},"score":1,"resource":{"primary":{"URL":"https:\/\/aacrjournals.org\/cebp\/article\/28\/7\/1134\/72066\/Predictive-Value-of-HPV-Testing-in-Self-collected"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,7,1]]},"references-count":40,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2019,7,1]]},"published-print":{"date-parts":[[2019,7,1]]}},"URL":"https:\/\/doi.org\/10.1158\/1055-9965.epi-18-1338","relation":{},"ISSN":["1055-9965","1538-7755"],"issn-type":[{"value":"1055-9965","type":"print"},{"value":"1538-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,7,1]]}}}