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

TL;DR

A new self-sampling tool for HPV testing in cervical cancer screening shows high accuracy and is preferred by many women for its comfort and privacy.

Contribution

The study introduces a novel self-sampling device for HPV genotyping with high concordance and patient acceptability in economically developed regions.

Findings

The self-sampling device showed excellent concordance with clinician-collected samples (κ = 0.937).

56.7% of participants preferred self-sampling when cost was considered, citing comfort and privacy as key factors.

Multivariate analysis linked sampling preference to age, HPV vaccination status, and comfort perception.

Abstract

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.

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.

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).

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.

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