Acting on the Call Towards Elimination: Diagnostic Accuracy and Acceptability of Human Papilloma Virus Self-Sampling Versus Clinician-Collected Specimens in Bahrain
Year: 2026
Type: preprint
Study design: Observational Study
Abstract: Background Cervical cancer remains a significant public health challenge in Bahrain, where screening is largely opportunistic and uptake is suboptimal. Human papillomavirus (HPV) self-sampling has demonstrated diagnostic accuracy comparable to clinician-collected specimens in multiple settings and may offer a culturally congruent strategy to expand participation in cervical cancer screening, particularly in conservative communities where embarrassment related to intimate examination is a well-documented barrier. This study evaluated the feasibility, diagnostic accuracy, and acceptability of HPV self-sampling compared with clinician-collected specimens among women in Bahrain. Methods This cross-sectional diagnostic accuracy and feasibility study was conducted at King Hamad University Hospital and Primary Health Care Centres in Bahrain between July and August 2025. Women aged 21–65 years attending gynaecology or women screening clinics were recruited, enriched with a purposively selected subgroup of women with confirmed HPV-positive status from the colposcopy clinic. Each participant self-collected a cervical sample using the Rovers Cervex-Brush® deposited in PreservCyt® liquid medium, followed immediately by a clinician-collected specimen using the same device and transport medium as the reference standard. Both specimens were analysed using the Cobas® HPV test (Roche Molecular Systems). Agreement between methods was assessed using Cohen's kappa coefficient (κ), and diagnostic performance was reported as sensitivity, specificity, and predictive values with 95% Wilson confidence intervals. Acceptability and screening preferences were assessed via a structured 15-item questionnaire. Results Sixty-one women were enrolled; 53 evaluable paired specimens were available for diagnostic analysis after excluding invalid and missing results. The clinician-collected reference standard identified 7 HPV-positive cases (13.2%). Against this reference, self-collected specimens achieved a sensitivity of 85.7% (95% CI: 48.7%–97.4%), specificity of 100.0% (95% CI: 92.3%–100.0%), positive predictive value of 100.0%, and negative predictive value of 97.9% (95% CI: 88.9%–99.6%). Observed agreement was 98.1%, and Cohen's kappa was 0.91 (95% CI: 0.74–1.00). Invalid result rates were identical across both collection methods (3.6%). Self-sampling instructions were rated as clear by 94.5% of participants, 80.0% found the procedure easy, and only 18.2% reported discomfort. More than half of the women (56.4%) preferred self-sampling for their next screening episode. No statistically significant associations were found between screening preference and age, education level, or HPV vaccination status. Conclusions HPV self-sampling using a liquid-medium brush device is technically feasible and yields results in very good agreement with clinician-collected specimens among Bahraini women. Self-sampling was broadly acceptable across diverse sociodemographic backgrounds, with privacy and convenience identified as primary drivers. These preliminary findings support the case for a larger, adequately powered validation study and highlight the potential of self-sampling as a strategy to expand cervical cancer screening participation in Bahrain, contributing to the WHO 2030 elimination agenda.
Source: Research Square
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7204453232