Observational studyBMC medicine2025
High-risk human papillomavirus testing in first-void urine as a novel and non-invasive cervical cancer screening modality-a Danish diagnostic test accuracy study.
Observational study in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05065853 (Urinary and Vaginal HPV Testing as a Novel Cervical Cancer Screening Tool), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Urinary and Vaginal HPV Testing as a Novel Cervical Cancer Screening Tool: a Diagnostic Test Accuracy Study
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Agreement and Diagnostic Performance of Urinary HPV Testing Versus Clinician-Collected Cervico-Vaginal Sampling: A Prospective Cross-Sectional Study in a Romanian Cohort.Medical sciences (Basel, Switzerland) · 2026Article
- Biology-aligned cervical cancer screening: target-centric biomarkers and next-generation diagnostic platforms.Biomarker research · 2026Review
- Observational
- Performance of a novel, urine-based test for the detection of cervical human papillomavirus infection.Journal of clinical microbiology · 2026Article
- Comparative efficacy, feasibility and acceptability of HPV DNA testing on first-void urine versus self-collected vaginal samples: a real-world study in a resource-limited setting.BMJ global health · 2026Article
- Age distribution of high-risk HPV infection and cervical lesions in an unvaccinated adult Brazilian population within an organized screening program.Scientific reports · 2026Article
- A United States study of self-collected urine vs clinician-collected cervical sample for HPV and cervical intraepithelial neoplasia grade two or worse detection: Cross-sectional agreement and diagnostic accuracy study.Preventive medicine reports · 2025Article
- Review
- Feasibility of First-Void Urinary and Vaginal Self-Sampling for High-Risk Human Papillomavirus Testing Among Women Living With Human Immunodeficiency Virus in Guinea-Bissau-A Multicenter Cross-Sectional Study.Journal of medical virology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundFirst-void urine (FVU) collection for high-risk human papillomavirus (hrHPV) testing has game-changing potential to improve cervical cancer prevention among under-screened women who remain unreached by clinician-based cervical cancer screening and vaginal self-sampling. Yet, the wide variation in the clinical accuracy of hrHPV testing in urine for detecting high-grade cervical intraepithelial neoplasia (CIN2 + /CIN3 +) across studies and clinical settings highlights the importance of local piloting and validation. This study determined the relative clinical accuracy of hrHPV testing in FVU versus clinician-collected cervical samples to detect CIN2 + /CIN3 + in a Danish referral population.
methodsIn a diagnostic test accuracy study, paired FVU (10 mL Colli-Pee device; index test) and cervical samples (Cervex Combi brush; comparator test) were obtained from 325 women aged 23-64 years (median age 36.0 years (IQR 29-46) who were either referred for colposcopy and biopsy taking or a cervical excision (reference test; available for all participants). Samples were tested using Allplex HR HPV DNA extended genotyping assay. Same absolute cut-off for hrHPV positivity applied for cervical samples was used for FVU. Of the 325 women, 145 (44.6%), 180 (55.4%), and 138 (42.5%) were diagnosed with < CIN2, CIN2 + , and CIN3 + , respectively.
resultsSensitivity to detect CIN2 + (ratio 0.97, 95% CI 0.92-1.02, p
conclusionsThis is the first study proving similar CIN2 + /CIN3 + sensitivity for FVU-hrHPV testing using the 10-mL Colli-Pee device and Allplex HR HPV assay compared to testing in cervical samples. From an implementation perspective, further research is needed to gather additional clinical accuracy and acceptability data on hrHPV testing of FVU-device collection in under-screened populations to support its broader integration into screening programmes.
trial registrationClinicaltrials.gov: NCT05065853.
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