Abstract
INTRODUCTION: Cervical cancer, driven by persistent high-risk human papillomavirus (hrHPV) infection, remains a global health challenge, especially in low- and middle-income areas such as western China. Despite the critical role of HPV testing in early detection, coverage in China remains low due to cultural, psychological, and other barriers. Self-collected urine and vaginal samples offer alternative methods for sample collection. This study aimed to evaluate the feasibility and acceptability of detecting hrHPV and cervical intraepithelial neoplasia grade 2 or worse (CIN2+) via urine and vaginal self-sampling compared with clinician sampling in urban areas of western China. METHODS: A cross-sectional survey was conducted from November 2022 to March 2023 in urban areas of western China. The participants provided self-collected urine and vaginal samples for hrHPV testing and completed questionnaires on acceptability of self-sampling. The HPV positivity, agreement, and kappa value were calculated to assess concordance between self- and clinician sampling. The sensitivity, specificity, agreement, predictive values, and likelihood ratios were used to evaluate the clinical performance of both methods for detecting CIN2+. RESULTS: A total of 2,228 female subjects aged 21-71 years were recruited, and self-collected urine samples, vaginal samples, and clinician-collected cervical samples were obtained. The sensitivity of clinician sampling, urine self-sampling and vaginal self-sampling were 80.00% (95% CI: 44.22-96.46), 70.00% (95% CI: 35.37-91.91) and 90.00% (95% CI: 54.12-99.48) for CIN2+; the specificity for