{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T13:19:09Z","timestamp":1785417549365,"version":"3.56.0"},"reference-count":40,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:00:00Z","timestamp":1784851200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"\u201cIuliu Ha\u021bieganu\u201d University of Medicine and Pharmacy","award":["32153\/18\/16.12.2024"],"award-info":[{"award-number":["32153\/18\/16.12.2024"]}]},{"award":["32153\/18\/16.12.2024"],"award-info":[{"award-number":["32153\/18\/16.12.2024"]}],"id":[{"id":"https:\/\/ror.org\/051h0cw83","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Med. Sci.","Medical Sciences"],"abstract":"<jats:p>Background: Cervical cancer screening uptake in Romania remains below 20%, with invasive sampling cited as a major participation barrier. Urinary HPV testing is a non-invasive alternative, but data from Eastern European populations are scarce and reporting stratified by histological grade is inconsistent. Objectives: To evaluate the agreement between paired urinary and clinician-collected cervico-vaginal HPV testing, and to assess the diagnostic performance of urinary HPV testing for biopsy-confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Methods: Prospective cross-sectional study in three outpatient obstetrics and gynecology clinics (May 2025\u2013May 2026). A total of 230 women aged 25\u201370 years provided paired cervico-vaginal (PreservCyt\u00ae) and first-void urine (Colli-Pee\u00ae) specimens. To capture the full spectrum of disease probability, participants were recruited across three clinical scenarios: primary screening, cytology triage and HPV-positive triage. A multiplex RT-PCR assay targeted a total of 14 high-risk HPV genotypes, providing separate identification for HPV16 and HPV18, alongside a pooled detection for the remaining 12 high-risk strains. Colposcopy-guided cervical biopsy served as the reference standard. Results: Paired hrHPV testing achieved substantial agreement (\u03ba = 0.696, 95% CI 0.604\u20130.788), with higher genotype-specific concordance for HPV16 (\u03ba = 0.755) and HPV18 (\u03ba = 0.789). Discordance was directionally asymmetric (30 cervical-positive\/urine-negative versus 4 urine-positive\/cervical-negative; McNemar p &lt; 0.001). For biopsy-confirmed CIN2+ (59 of 230; 25.7%), urinary hrHPV showed a sensitivity of 86.4% (95% CI 75.5\u201393.0), specificity 56.7%, positive predictive value 40.8% and negative predictive value 92.4%, compared with 91.5%, 43.3%, 35.8% and 93.7% for cervico-vaginal testing. Urinary HPV positivity increased monotonically with histological severity (25.0% no-lesion, 69.0% CIN1, 86.4% CIN2+; linear-by-linear p &lt; 0.001). Conclusions: Urinary HPV testing demonstrates substantial agreement with clinician-collected sampling, near-equivalent negative predictive value, and a robust dose\u2013response with histological severity. It is a clinically credible non-invasive entry point for a triage cascade in settings such as Romania, where low participation rather than analytical performance is the principal screening barrier.<\/jats:p>","DOI":"10.3390\/medsci14040423","type":"journal-article","created":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T07:36:13Z","timestamp":1784878573000},"page":"423","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Agreement and Diagnostic Performance of Urinary HPV Testing Versus Clinician-Collected Cervico-Vaginal Sampling: A Prospective Cross-Sectional Study in a Romanian Cohort"],"prefix":"10.3390","volume":"14","author":[{"given":"Ionel-Daniel","family":"Nati","sequence":"first","affiliation":[{"name":"2nd Department of Obstetric and Ginecology, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400610 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mihaela","family":"Oancea","sequence":"additional","affiliation":[{"name":"2nd Department of Obstetric and Ginecology, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400610 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen Mihaela","family":"Mihu","sequence":"additional","affiliation":[{"name":"Department of Morphofunctional Sciences, Iuliu Ha\u021bieganu University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan","family":"Mihu","sequence":"additional","affiliation":[{"name":"2nd Department of Obstetric and Ginecology, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400610 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Razvan","family":"Ciortea","sequence":"additional","affiliation":[{"name":"2nd Department of Obstetric and Ginecology, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400610 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristian","family":"Iuhas","sequence":"additional","affiliation":[{"name":"2nd Department of Obstetric and Ginecology, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400610 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Bucuri","sequence":"additional","affiliation":[{"name":"2nd Department of Obstetric and Ginecology, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400610 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Patricia","family":"Roman","sequence":"additional","affiliation":[{"name":"2nd Department of Obstetric and Ginecology, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400610 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina Mihaela","family":"Ormindean","sequence":"additional","affiliation":[{"name":"2nd Department of Obstetric and Ginecology, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400610 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viorela","family":"Suciu","sequence":"additional","affiliation":[{"name":"2nd Department of Obstetric and Ginecology, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400610 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Razvan","family":"Chereches","sequence":"additional","affiliation":[{"name":"HIVE Health Innovation Center, Babe\u0219-Bolyai University, 400094 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrei Mihai","family":"Malutan","sequence":"additional","affiliation":[{"name":"2nd Department of Obstetric and Ginecology, \u201cIuliu Hatieganu\u201d University of Medicine and Pharmacy, 400610 Cluj-Napoca, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2247","DOI":"10.1007\/s10096-024-04963-z","article-title":"A review of urinary HPV testing for cervical cancer management and HPV vaccine surveillance: Rationale, strategies, and limitations","volume":"43","author":"Cheng","year":"2024","journal-title":"Eur. 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