Diagnostic Performance of Urine-Based Versus Cervical Swab Human Papillomavirus Testing Among Women in a High-Burden Region in Northeastern, India: A Prospective Cross-Sectional Study.

Cervical cancer ranks as the second most prevalent cancer among women in India, with Mizoram exhibiting the highest incidence rate in the nation. HPV cervical swab testing stands as the definitive screening tool; however, urine-based testing presents a compelling minimally invasive alternative that can significantly enhance screening coverage in resource-limited environments. This study robustly assessed the diagnostic accuracy of urine samples compared to cervical swabs for detecting high-risk HPV and analyzing genotype distribution within a high-burden population in northeastern India. C ross-sectional study was conducted among 516 women attending gynecology departments in Aizawl, Mizoram from November 2023 to March 2025. Paired cervical and urine samples were collected and tested for HPV DNA using consensus primers (MY09/MY11, GP5+/GP6+), followed by genotyping for 20 HPV types. All data were retrieved through questionnaire based when collecting the samples. Diagnostic accuracy metrics, kappa agreement, and ROC analysis were calculated using cervical swab results as the reference. Logistic regression identified sociodemographic and clinical predictors of HPV positivity. HPV DNA was detected in 12.0% (62/516) of cervical swabs and 4.5% (23/516) urine samples with an overall positivity rate of 13.2%. Genotype HPV-16, HPV-18 and HPV-33, were the most frequent types detected in cervical swabs. Urine-based testing demonstrated high specificity (98.5%) but low sensitivity (25.8%) with overall diagnostic accuracy of 86.4% and fair agreement (κ = 0.333, p < 0.001). ROC analysis yielded an AUC of 0.801. Predictors of HPV positivity included younger age, multiple lifetime sexual partners, early sexual debut, and recent STI history, with effect sizes varying by sampling method. Urine-based HPV testing, while less sensitive, demonstrates high specificity and serves as a potential utility for adjunct screening tool in settings with cultural, logistical and infrastructure barriers to pelvic exams. Incorporating urine-based testing into in national HPV screening guidelines as well as support WHO’s cervical cancer elimination targets particularly in high-burden, underserved regions such as Mizoram.