Performance of a New Brazilian Self-Sampling Device for High-Risk Human Papillomavirus Screening

OBJECTIVE: To evaluate the performance of a new Brazilian self-sampling device (COARI®) compared with clinician-collected samples for high-risk human papillomavirus (hrHPV) detection and partial typing. METHODS: This diagnostic agreement study included 57 women who underwent routine cervical screening or follow-up at a private health center in Maringá, Brazil, between May and October 2023. Each participant provided two samples: a self-collected vaginal sample using the COARI® device (Kolplast, Brazil) and a clinician-collected cervical sample. Both were tested using the Cobas® HPV 4800 assay (Roche, USA), which detects HPV16, HPV18, and a pooled group of 12 other hrHPV types. RESULTS: hrHPV detection was significantly higher in self-collected samples than in clinician-collected ones (52.9% vs. 37.2%; P = 0.008). The Overall agreement between sampling methods was 84.3%. All discordant cases (15.7%) were hrHPV-positive in self-collected samples and negative in clinician-collected specimens, suggesting potentially greater sensitivity for self-sampling. The COARI® device showed 100% sensitivity and a 100% negative predictive value, with an overall accuracy of 84.3%. CONCLUSION: The COARI® self-sampling device demonstrated reliable and effective performance for hrHPV detection and partial typing, showing strong potential to increase access to and coverage of cervical cancer screening in Brazil. Further studies with larger and more diverse populations are needed to validate these findings and inform public health implementation.