ORIGINAL RESEARCH article
Front. Med.
Sec. Obstetrics and Gynecology
This article is part of the Research TopicMolecular Innovations in HPV DiagnosticsView all articles
Concordance and Acceptability of a Novel Human Papillomavirus Self-Collection Tool for Cervical Cancer Screening in Economically Developed Regions: A Prospective Cohort Study in Shanghai, China
Provisionally accepted
- 1Shanghai University of Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China
- 2shanghai east hospital, Shanghai, China
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Background: This study aimed to evaluate the concordance and clinical applicability of a novel cervical self-sampling device for human papillomavirus (HPV) genotyping, and to identify factors influencing women's preference for self-collection in an economically developed setting. Methods: In this prospective paired-sample study conducted at Shanghai East Hospital (September 2024-February 2025), 276 eligible women from gynecological outpatient clinics underwent sequential cervical sampling: self-collection followed by clinician-collected sampling. Both specimens were analyzed in parallel for HPV genotyping using standardized protocols. Using clinician sampling as the reference standard, concordance parameters including sensitivity, specificity, and predictive values were calculated with 95% confidence intervals (CIs). Patient-reported outcomes (n=268 valid responses) on acceptability, comfort, and preference were collected through a structured questionnaire. Results: The self-sampling method showed excellent concordance with clinician sampling (κ=0.937; 95% CI:0.89-0.98). Concordance with clinician sampling was as follows: sensitivity 91.4% (95%CI: 83.2-96.5%), specificity 100% (95%CI: 98.2-100%), accuracy 97.5% (95%CI: 94.8-99.0%), positive predictive value 100% (95%CI: 95.0-100%), and negative predictive value 96.5% (95%CI: 93.2-98.5%). While 41.4% of participants initially preferred self-sampling, this proportion increased to 56.7% when cost considerations were introduced. Key determinants for self-sampling preference included: comfort of home-based collection (59.2%), perceived reduction in pain 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 high concordance comparable to clinician-collected specimens while demonstrating superior patient acceptability. Its advantages 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.
Keywords: cervical cancer screening, concordance, Economically Developed Regions, HPV self- collection, Patient- Centered Care, screening adherence
Received: 03 Dec 2025; Accepted: 31 Jan 2026.
Copyright: © 2026 Xu, Liu, Li, Zhang and Li. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Bowen Xu
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