A single self-collected cervical specimen showed substantial agreement with clinician-collected samples for cytology, high-risk human papillomavirus testing, and sexually transmitted infection–related molecular testing in a prospective paired study.
The researchers cautioned that the findings are preliminary evidence of feasibility and agreement, not definitive validation of diagnostic performance. They also noted that implementation would require appropriate laboratory infrastructure, trained personnel, specimen transport systems, and referral pathways.
Study Design
Researchers conducted a prospective paired study of 520 women undergoing routine cervical cancer screening at a gynecologic clinic in Korea between December 2024 and February 2025. Participants first performed cervical self-sampling using the Earlypap device, followed by clinician-collected sampling with a colposcopic cytobrush during the same visit.
Paired specimens from each participant were analyzed for liquid-based cytology, high-risk HPV testing with the cobas 4800 system, and STI-related molecular testing with multiplex real-time PCR. STI analyses were restricted to 504 participants younger than 60 years.
Overall, 12.5% of participants reported no prior cervical cancer screening, with the highest proportion among women younger than 30 years. The researchers later discussed self-sampling as a potential strategy to reduce patient-level barriers, while noting that the study did not directly assess barriers to clinic-based screening.
The main analysis evaluated agreement between self- and clinician-collected specimens using percentage concordance and Cohen’s kappa coefficients. Researchers also assessed first-attempt sampling success, participant preference, willingness to use self-sampling in the future, and age-specific patterns of abnormal cytology, high-risk HPV positivity, and STI-related organism detection.
Feasibility and Participant Acceptability
Self-sampling was completed successfully on the first attempt by 98.5% of participants, with a median self-sampling time of 100 seconds. Most participants rated the procedure as easy to perform, 92.1% preferred self-sampling over clinician collection, and 94.6% said they would be willing to use self-sampling for future screening.
Diagnostic Agreement
Overall agreement between self- and clinician-collected specimens was 91.7% for cytology, 95.4% for high-risk HPV testing, and 97.0% for STI-related molecular testing. Kappa values were 0.67 for cytology, 0.79 for high-risk HPV testing, and 0.72 for STI-related molecular testing, agreement the researchers characterized as substantial across all three modalities.
For cytology, unsatisfactory rates were similar between self-collected and clinician-collected specimens, at 1.4% vs 1.7%, respectively. Self-sampling and clinician collection identified the same 2 cases of high-grade squamous intraepithelial lesion. Low-grade squamous intraepithelial lesion was detected in 2.3% of self-collected specimens vs 1.2% of clinician-collected specimens.
High-risk HPV was detected in 14.8% of self-collected specimens vs 12.9% of clinician-collected specimens. Among high-risk HPV–positive cases, 17 were detected only in self-collected samples and 7 were detected only in clinician-collected samples.
Organisms included in the STI-related molecular panel were detected in 46.8% of self-collected samples vs 44.8% of clinician-collected samples. Ureaplasma species were the most frequently detected organisms in both sampling methods, accounting for roughly 40% of positive cases. Candida albicans was detected in approximately 5% of specimens. The researchers noted that C albicans is not classified as an STI and cautioned that routine screening and treatment for Mycoplasma and Ureaplasma species are not recommended in asymptomatic women.
Age Patterns
Abnormal cytology was highest among women younger than 30 years, declined through the middle-aged groups, and showed a modest increase among women aged 60 years or older. High-risk HPV positivity followed a similar overall pattern but with a more pronounced secondary increase in women aged 60 years or older. STI-related organism detection, assessed only in participants younger than 60 years, was highest in the youngest group and decreased progressively with age.
Histologic Follow-Up
Histologic follow-up was limited. Colposcopy and biopsy were performed selectively, guided by screening results, HPV genotype, colposcopic findings, prior screening history, participant preference, and clinician judgment, rather than mandated for every patient with abnormal cytology or high-risk HPV positivity. Where biopsy was performed, both patients with high-grade squamous intraepithelial lesion identified by self-sampling and clinician sampling had high-grade squamous intraepithelial lesion confirmed on histopathology.
Limitations
The researchers identified several limitations: the lack of systematic histologic confirmation in all participants with abnormal results; the single-center, clinic-based Korean study population, which may limit generalizability to other populations and health systems; the modest sample size, which they said may be insufficient to establish definitive equivalence between self- and clinician-collected samples; and reliance on a single liquid-based cytology platform, meaning results may not generalize to other validated systems such as ThinPrep or SurePath.
They also noted that integrating this approach into practice would require laboratory infrastructure, trained personnel, specimen transport systems, and referral pathways that may not be available in all settings.
From the Study Authors
Lead study author Chang Gok Woo, of Chungbuk National University, and colleagues wrote that the integrated approach “may reduce the need for multiple sampling procedures” and could help improve the efficiency of cervical cancer screening programs.
Disclosures: The study received no external funding. Biodyne Co., Ltd., manufacturer of the Earlypap device, provided the device and related materials. The researchers reported no conflicts of interest.
Source: Diagnostics