Diagnostic Accuracy and Acceptability of a Novel Human Papillomavirus Self-Collection Tool for Cancer Screening in Eco-nomically Developed Regions: A Prospective Cohort Study in Shanghai, China

Abstract Objective To evaluate the diagnostic accuracy and clinical applicability of a novel cervical self-sampling device for HPV genotyping, and to determine the factors influencing patient preference for self-collection methods in economically developed regions. Methods In this prospective paired-sample study conducted at Shanghai East Hospital (September 2024-February 2025), 276 high-risk women from gynecological outpatient clinics under-went sequential cervical sampling: self-collection followed by clinician-administered sampling. Both specimens underwent parallel HPV genotyping analysis using standardized protocols. Using clinician sampling as the reference standard, we calculated diagnostic parameters including sensitivity, specificity, and predictive values with 95% confidence intervals. Patient-reported outcomes (n = 268 valid responses) assessing acceptability, comfort level, and preference were collected through a structured questionnaire. Results The self-sampling method demonstrated excellent concordance with clinician sampling (κ = 0.937; 95% CI:0.89–0.98). Diagnostic performance metrics were as follows: sensitivity 91.4% (83.2–96.5%), specificity 100% (98.2–100%), accuracy 97.5% (94.8–99.0%), positive predictive value 100% (95.0-100%), and negative predictive value 96.5% (93.2–98.5%). While 41.4% of participants initially preferred self-sampling, this proportion increased to 56.7% when considering cost factors. Key determinants for self-sampling preference included: home-based collection comfort (59.2%), perceived pain reduction through self-controlled sampling pressure (57.2%), and privacy preservation (56.6%). Multivariate analysis revealed significant associations between sampling preference and age (p < 0.0001), HPV vaccination status (p = 0.0064), previous screening experience (p = 0.0064), and comfort perception (p < 0.0001). Conclusion The novel self-sampling device achieves diagnostic accuracy comparable to clinician-collected specimens while demonstrating superior patient acceptability. Its ad-vantages in privacy protection, procedural comfort, and cost-effectiveness position it as a promising complementary strategy to enhance cervical cancer screening coverage, particularly among under-screened high-risk populations.