Integrated Cervical Self-Sampling for Cytology, High-Risk Human Papillomavirus, and Sexually Transmitted Infection Testing: A Prospective Study.

Background/

Objectives

Cervical self-sampling is increasingly used for high-risk human papillomavirus (hrHPV) testing, but evidence for integrated liquid-based cytology (LBC) and sexually transmitted infection (STI) testing is limited. This study evaluated the feasibility and diagnostic agreement of an integrated single-step self-sampling approach for LBC, hrHPV, and STI testing.

Methods

In this prospective paired study, 520 Korean women for cervical cancer screening between December 2024 and February 2025 were enrolled. Each participant first underwent cervical self-sampling using Earlypap®, followed by clinician-collected sampling. Paired specimens were analyzed for LBC, hrHPV, and STI detection. Percentage agreement and Cohen's kappa coefficients (κ) were calculated.

Results

Self-sampling was successful on the first attempt in 98.5% of participants, with 92.1% preferring it over clinician-collection. LSIL was detected in 2.3% of self-collected and 1.2% of clinician-collected specimens, and HSIL was detected in 0.4% of both specimen types. hrHPV positivity was 14.8% in self- and 12.9% in clinician-collected specimens. Ureaplasma spp. were frequently detected, and Candida albicans was identified in approximately 5% of specimens. Overall agreement was 91.7% (κ = 0.67) for LBC, 95.4% (κ = 0.79) for hrHPV, and 97.0% (κ = 0.72) for STI.

Conclusions

Integrated cervical self-sampling using a single-step device demonstrated high feasibility and substantial agreement with clinician-based sampling, supporting its potential to improve screening efficiency and reduce participation barriers.