Integrated Cervical Self-Sampling for Cytology, High-Risk Human Papillomavirus, and Sexually Transmitted Infection...

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.