Diagnostic Accuracy of Urine-Based HPV Testing Compared With Clinician-Collected Cervical Samples for Cervical Intraepithelial Neoplasia Grade 2 or Worse (CIN2+) Detection: A Systematic Review and Meta-Analysis.

Cervical cancer remains a major global health challenge, and human papillomavirus (HPV) testing has become central to screening and prevention programs. Conventional clinician-collected cervical samples, while effective, face barriers of invasiveness, infrastructure requirements, and limited acceptability in certain populations. Urine-based HPV testing has emerged as a potential alternative, offering advantages in convenience and patient preference, but concerns regarding diagnostic accuracy remain. This systematic review and meta-analysis, conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-diagnostic test accuracy (DTA) guidelines, evaluated the diagnostic accuracy of urine-based HPV testing for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with clinician-collected cervical samples. A comprehensive search of PubMed, Embase, Scopus, and the Cochrane Library from January 2010 to August 2025 identified five eligible studies comprising 1,031 participants. Data were pooled using a bivariate random-effects model. Urine HPV testing demonstrated a pooled sensitivity of 74% (95% confidence intervals (CI), 67-80%) and a specificity of 52% (95% CI, 43-61%). Performance improved significantly when first-void urine collection and PCR-based assays were employed, with sensitivity approaching that of self-collected vaginal samples. Cervical samples consistently outperformed urine samples in sensitivity, though patient acceptability was higher for urine testing, with over 90% of women preferring it. The included studies had generally low risk of bias, and the heterogeneity was primarily related to assay type and urine collection methods. These findings suggest that while urine HPV testing cannot yet replace cervical sampling in primary screening, it holds strong potential as a complementary strategy, not replacement, to improve screening uptake.