Clinical Performance and User-Informed Refinement of an Indigenous HPV Self-Collection Device for Cervical Cancer Screening in Resource-Constrained Settings

Abstract

Background: HPV self-sampling has improved screening participation but remains constrained by cost and lack of optimised collection devices in resource-constrained settings. This study reports the iterative development of an indigenous self-collection device across successive prototypes. Methods: In this prospective study, women ≥ 30 years were recruited from community and higher-risk clinical cohorts including women living with HIV and colposcopy referrals. Each participant used one of three CERVICHECK™ prototypes (P1–P3) for vaginal self-sampling, followed by physician-collected cervical sampling. Self-collected samples were tested using an indigenous PCR-based HPV assay and physician-collected samples using Cobas 6800. Clinical performance was assessed against histologically confirmed CIN2+ as the primary endpoint. Results: Of 756 enrolled women, 743 paired samples were evaluable; invalidity rate was 1.7%. Iterative device refinement was associated with stepwise improvements in analytical agreement with reference standard (Cohen’s κ: P1:0.49; P2:0.47; P3:0.67). Clinical sensitivity for CIN2+ detection using self-collected samples increased from 40.0% (95%CI 5.3–85.3) with P1 to 75.0% (95%CI 34.9–96.8) with P2 and 93.6% (95%CI 78.6–99.2) with P3. For P3, clinical sensitivity and specificity of self-collected samples was 93.6% (95%CI 78.6–99.2) for CIN2+ and 67.4% (95%CI 58.6–75.4) for ≤CIN1 lesions, yielding a relative clinical sensitivity of 1.0. Reported concerns declined across successive prototypes (P1:47.6%, P2:25.5%, P3:13.4%). Conclusions: Iterative, user-informed refinement of indigenous HPV self-collection device achieved clinically meaningful performance comparable to standard sampling for CIN2+ detection. Impact: Optimised affordable indigenous self-collection solutions may offer scalable and equitable options for implementing HPV-based cervical cancer screening in resource-constrained settings.