{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T06:53:23Z","timestamp":1793084003413,"version":"4.5.0"},"reference-count":43,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T00:00:00Z","timestamp":1694044800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>In the context of cervical cancer prevention, where human papillomavirus (HPV) infection is pivotal, HPV testing is replacing Pap Smear in primary screening. This transition offers an opportunity for integrating self-sampling to enhance coverage. We evaluated the accuracy of HPV testing using self-collected urine and vaginal samples, comparing them to physician-collected cervical swabs. From a cohort of 245 women with abnormal cytology, we collected self-sampled vaginal, urine, and clinician-administered cervical specimens. Employing Anyplex\u2122II HPV28 assay, outcomes revealed HPV positivity rates of 75.1% (cervical), 78.4% (vaginal), and 77.1% (urine). Significant, hr-HPV detection concordance was observed between self-taken cervical samples and clinical counterparts (k = 0.898 for vaginal; k = 0.715 for urine). This study extends beyond accuracy, highlighting self-collected sample efficacy in detecting high-grade cervical lesions. The insight underscores self-sampling\u2019s role in bolstering participation and aligns with WHO\u2019s goal to eliminate cervical cancer by 2030.<\/jats:p>","DOI":"10.3390\/v15091889","type":"journal-article","created":{"date-parts":[[2023,9,7]],"date-time":"2023-09-07T09:56:36Z","timestamp":1694080596000},"page":"1889","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":37,"title":["Accuracy of Human Papillomavirus (HPV) Testing on Urine and Vaginal Self-Samples Compared to Clinician-Collected Cervical Sample in Women Referred to Colposcopy"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2273-6986","authenticated-orcid":false,"given":"Marianna","family":"Martinelli","sequence":"first","affiliation":[{"name":"Department of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6112-7572","authenticated-orcid":false,"given":"Chiara","family":"Giubbi","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3140-4062","authenticated-orcid":false,"given":"Maria Letizia","family":"Di Meo","sequence":"additional","affiliation":[{"name":"IRCCS San Gerardo dei Tintori, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Perdoni","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0143-3601","authenticated-orcid":false,"given":"Rosario","family":"Musumeci","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Biagio Eugenio","family":"Leone","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy"},{"name":"IRCCS San Gerardo dei Tintori, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5688-2194","authenticated-orcid":false,"given":"Robert","family":"Fruscio","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy"},{"name":"IRCCS San Gerardo dei Tintori, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6734-739X","authenticated-orcid":false,"given":"Fabio","family":"Landoni","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy"},{"name":"IRCCS San Gerardo dei Tintori, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6166-1134","authenticated-orcid":false,"given":"Clementina Elvezia","family":"Cocuzza","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, University of Milano-Bicocca, 20900 Monza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,9,7]]},"reference":[{"key":"ref_1","unstructured":"Ervik, M., Lam, F., Ferlay, J., Mery, L., Soerjomataram, I., and Bray, F. (2020). Cancer Today, International Agency for Research on Cancer."},{"key":"ref_2","unstructured":"Bruni, L., Albero, G., Serrano, B., Mena, M., Collado, J.J., G\u00f3mez, D., Munoz, J., Bosch, F.X., and de Sanjos\u00e9, S. (2023). Human Papillomavirus and Related Diseases in the World, ICO\/IARC Information Centre on HPV. Summary Report 10 March 2023."},{"key":"ref_3","unstructured":"Aiom-Airtum, I. (2020). Numeri del Cancro in Italia, Edizione."},{"key":"ref_4","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":"ref_5","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":"ref_6","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":"ref_7","doi-asserted-by":"crossref","first-page":"S14","DOI":"10.1016\/j.jcv.2015.09.014","article-title":"VALGENT: A protocol for clinical validation of human papillomavirus assays","volume":"76","author":"Arbyn","year":"2016","journal-title":"J. Clin. Virol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"516","DOI":"10.1002\/ijc.24010","article-title":"Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older","volume":"124","author":"Meijer","year":"2009","journal-title":"Int. J. Cancer"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1816","DOI":"10.1158\/1055-9965.EPI-19-0239","article-title":"Role of HPV Genotype, Multiple Infections, and Viral Load on the Risk of High-Grade Cervical Neoplasia","volume":"28","author":"Adcock","year":"2019","journal-title":"Cancer Epidemiol. Biomark. Prev."},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Zappacosta, R., Sablone, F., Pansa, L., Buca, D., and Rosini, S. (2017). Analytic and Diagnostic Performances of Human Papillomavirus E6\/E7 mRNA Test on up-to 11-Year-Old Liquid-Based Cervical Samples. A Biobank-Based Longitudinal Study. Int. J. Mol. Sci., 18.","DOI":"10.3390\/ijms18071480"},{"key":"ref_11","unstructured":"(2023, July 15). Epicentro Il portale dell\u2019epidemiologia per la Sanit\u00e0 Pubblica. La sorveglianza Passi. Available online: https:\/\/www.epicentro.iss.it\/passi\/dati\/ScreeningCervicale#dati."},{"key":"ref_12","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 programme 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":"ref_13","doi-asserted-by":"crossref","first-page":"E159","DOI":"10.1007\/BF03405681","article-title":"Self-collected HPV Testing Improves Participation in Cervical Cancer Screening: A Systematic Review and Meta-analysis","volume":"104","author":"Racey","year":"2013","journal-title":"Can. J. Public Health-Rev. Can. Sante Publique"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"308","DOI":"10.1002\/ijc.33967","article-title":"Meta-analysis of agreement\/concordance statistics in studies comparing self- vs clinician-collected samples for HPV testing in cervical cancer screening","volume":"151","author":"Arbyn","year":"2022","journal-title":"Int. J. Cancer"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"805","DOI":"10.1038\/s41416-022-02094-w","article-title":"Offering HPV self-sampling kits: An updated meta-analysis of the effectiveness of strategies to increase participation in cervical cancer screening","volume":"128","author":"Costa","year":"2023","journal-title":"Br. J. Cancer"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.ejogrb.2017.06.036","article-title":"First-void urine: A potential biomarker source for triage of high-risk human papillomavirus infected women","volume":"216","author":"Pattyn","year":"2017","journal-title":"Eur. J. Obstet. Gynecol. Reprod. Biol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"859","DOI":"10.1007\/s10096-017-3179-1","article-title":"Human papillomavirus genotype and viral load agreement between paired first-void urine and clinician-collected cervical samples","volume":"37","author":"Tjalma","year":"2018","journal-title":"Eur. J. Clin. Microbiol. Infect. Dis."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"g6252","DOI":"10.1136\/bmj.g6252","article-title":"URINARY TESTING FOR HPV Urine testing for HPV: Rationale for using first void","volume":"349","author":"Vorsters","year":"2014","journal-title":"BMJ-Br. Med. J."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"e76","DOI":"10.3802\/jgo.2019.30.e76","article-title":"Evaluation of satisfaction with three different cervical cancer screening modalities: Clinician-collected Pap test vs. HPV test by self-sampling vs. HPV test by urine sampling","volume":"30","author":"Shin","year":"2019","journal-title":"J. Gynecol. Oncol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1158\/1940-6207.CAPR-20-0280","article-title":"The Acceptability and Preference of Vaginal Self-sampling for Human Papillomavirus (HPV) Testing among a Multi-ethnic Asian Female Population","volume":"14","author":"Khoo","year":"2021","journal-title":"Cancer Prev. Res."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"e041512","DOI":"10.1136\/bmjopen-2020-041512","article-title":"Clinical performance and acceptability of self-collected vaginal and urine samples compared with clinician-taken cervical samples for HPV testing among women referred for colposcopy. A cross-sectional study","volume":"11","author":"Jochumsen","year":"2021","journal-title":"BMJ Open"},{"key":"ref_22","unstructured":"WHO Classification of Tumours Editorial Board (2020). World Health Organization Classification of Tumours, Female Genital Tumours, IARC. [5th ed.]."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"159","DOI":"10.2307\/2529310","article-title":"The measurement of observer agreement for categorical data","volume":"33","author":"Landis","year":"1977","journal-title":"Biometrics"},{"key":"ref_24","unstructured":"World Health Organization (2020). Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem, World Health Organization."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"232","DOI":"10.1016\/j.ygyno.2006.08.053","article-title":"Diagnostic accuracy of human papillomavirus testing in primary cervical screening: A systematic review and meta-analysis of non-randomized studies","volume":"104","author":"Koliopoulos","year":"2007","journal-title":"Gynecol. Oncol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"510","DOI":"10.1038\/s41416-020-0920-9","article-title":"Cervical screening: ESGO-EFC position paper of the European Society of Gynaecologic Oncology (ESGO) and the European Federation of Colposcopy (EFC)","volume":"123","author":"Kyrgiou","year":"2020","journal-title":"Br. J. Cancer"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"1054","DOI":"10.1111\/apm.12054","article-title":"Comparison of the Abbott RealTime High Risk HPV with Genomica HPV Clinical Array for the detection of human papillomavirus DNA","volume":"121","author":"Sias","year":"2013","journal-title":"APMIS"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"238","DOI":"10.1016\/j.jviromet.2017.07.009","article-title":"Comparison of the analytical and clinical performance of five tests for the detection of human papillomavirus genital infection","volume":"248","author":"Alonso","year":"2017","journal-title":"J. Virol. Methods"},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1042","DOI":"10.1002\/jmv.22088","article-title":"Comparative evaluation of different DNA extraction methods for HPV genotyping by linear array and INNO-LiPA","volume":"83","author":"Benevolo","year":"2011","journal-title":"J. Med. Virol."},{"key":"ref_30","doi-asserted-by":"crossref","unstructured":"Martinelli, M., Musumeci, R., Sechi, I., Sotgiu, G., Piana, A., Perdoni, F., Sina, F., Fruscio, R., Landoni, F., and Cocuzza, C.E. (2019). Prevalence of Human Papillomavirus (HPV) and Other Sexually Transmitted Infections (STIs) among Italian Women Referred for a Colposcopy. Int. J. Environ. Res. Public Health, 16.","DOI":"10.3390\/ijerph16245000"},{"key":"ref_31","doi-asserted-by":"crossref","unstructured":"Martinelli, M., Musumeci, R., Rizzo, A., Muresu, N., Piana, A., Sotgiu, G., Landoni, F., and Cocuzza, C. (2019). Prevalence of Chlamydia trachomatis Infection, Serovar Distribution and Co-Infections with Seven High-Risk HPV Types among Italian Women with a Recent History of Abnormal Cervical Cytology. Int. J. Environ. Res. Public Health, 16.","DOI":"10.3390\/ijerph16183354"},{"key":"ref_32","doi-asserted-by":"crossref","unstructured":"Baasland, I., Romundstad, P.R., Eide, M.L., and Jonassen, C.M. (2019). Clinical performance of Anyplex II HPV28 by human papillomavirus type and viral load in a referral population. PLoS ONE, 14.","DOI":"10.1371\/journal.pone.0210997"},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1097\/AOG.0000000000000056","article-title":"High-risk and low-risk human papillomavirus and the absolute risk of cervical intraepithelial neoplasia or cancer","volume":"123","author":"Thomsen","year":"2014","journal-title":"Obstet. Gynecol."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"2177","DOI":"10.1158\/1055-9965.EPI-22-0757","article-title":"Validation of BD Onclarity HPV assay on vaginal self-samples versus cervical samples using the VALHUDES protocol","volume":"31","author":"Latsuzbaia","year":"2022","journal-title":"Cancer Epidemiol. Biomark. Prev."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"575","DOI":"10.1016\/j.ygyno.2021.06.010","article-title":"Clinical and analytical evaluation of the RealTime High Risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol","volume":"162","author":"Peeters","year":"2021","journal-title":"Gynecol. Oncol."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"105271","DOI":"10.1016\/j.jcv.2022.105271","article-title":"Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study","volume":"155","author":"Latsuzbaia","year":"2022","journal-title":"J. Clin. Virol."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1016\/j.jcv.2018.08.006","article-title":"VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples","volume":"107","author":"Arbyn","year":"2018","journal-title":"J. Clin. Virol."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"168","DOI":"10.1016\/j.canep.2014.01.004","article-title":"Comparison of HPV genotypes and viral load between different sites of genital tract: The significance for cervical cancer screening","volume":"38","author":"Zhang","year":"2014","journal-title":"Cancer Epidemiol."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"1510","DOI":"10.1093\/infdis\/jiaa587","article-title":"How Many Human Papillomavirus Types Do We Need to Screen For?","volume":"223","author":"Dillner","year":"2021","journal-title":"J. Infect. Dis."},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"972","DOI":"10.1080\/21645515.2020.1814097","article-title":"Human papillomavirus genotype-specific risks for cervical intraepithelial lesions","volume":"17","author":"Hansen","year":"2021","journal-title":"Hum. Vaccin. Immunother."},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"234","DOI":"10.1002\/jmv.25597","article-title":"Comparison of the performance of paired urine and cervical samples for cervical cancer screening in screening population","volume":"92","author":"Xu","year":"2020","journal-title":"J. Med. Virol."},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"k4823","DOI":"10.1136\/bmj.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-Br. Med. J."},{"key":"ref_43","doi-asserted-by":"crossref","unstructured":"Kim, M., Kim, J., Park, N.J., and Park, J.Y. (2022). Comparison of Seegene Anyplex II HPV28 assay with BD Onclarity HPV assay for human papillomavirus genotyping. 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