Replication Data for: "Optimizing HPV Screening in the Democratic Republic of the Congo: A Comparative Study of Self-Sampling, Clinician Sampling, and Molecular Assays"

Objectives. Given the need to expand access to cervical cancer screening in low-resource settings such as the Democratic Republic of the Congo (DRC), we aimed to assess the diagnostic performance of self-collected vaginal samples for the detection of high-risk human papillomavirus (hrHPV). We also sought to compare two molecular assays—careHPV® and cobas®4800—and to evaluate the potential compatibility of the careHPV® collection medium with PCR-based platforms. Methods. A cross-sectional study was conducted among 482 women aged 25–65 years attending a cervical cancer screening program in Kinshasa, DRC. Each participant provided three specimens: a self-collected vaginal swab, a clinician-collected cervical swab (both stored in the careHPV® collection medium), and a liquid-based cytology sample in ThinPrep®. Samples were tested for hrHPV using careHPV® and/or cobas®4800. Sensitivity, specificity, predictive values, and agreement (Cohen’s kappa) were calculated using cobas®4800 results on liquid-based cytology as the reference. Results. Using the careHPV® assay, self-collected samples yielded a sensitivity of 54.9% and a specificity of 95.6%, whereas clinician-collected samples showed a sensitivity of 61.8% and a specificity of 95.0%, compared to hrHPV detection in liquid-based cytology. When tested with cobas®4800, self-collected samples achieved a sensitivity of 88.1%, specificity of 89.5%, and accuracy of 89.3%. Clinician-collected samples reached the highest performance, with a sensitivity of 96.1% and an accuracy of 92.9%. Agreement between assays was substantial, particularly for self-collected samples (κ = 0.798). No major performance loss was observed when cobas®4800 was used with samples stored in the careHPV® medium. Conclusions. Self-sampling represents a viable alternative for hrHPV detection in the DRC context, especially when combined with PCR-based assays, and may help expand screening coverage in underserved settings.