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

Area of Science:

• Gynecology
• Oncology
• Virology

Background:

• Cervical cancer screening is crucial for early detection and prevention.
• High-risk human papillomavirus (hrHPV) is the primary cause of cervical cancer.
• Improving screening accessibility and coverage is a public health priority.

Purpose of the Study:

• To evaluate the performance of the COARI® self-sampling device for hrHPV detection.
• To compare self-collected samples with clinician-collected samples.
• To assess the COARI® device's utility in Brazil.

Main Methods:

• A diagnostic agreement study involving 57 women in Brazil.
• Comparison of self-collected vaginal samples (COARI® device) with clinician-collected cervical samples.
• Testing using the Cobas® HPV 4800 assay for hrHPV types.

Main Results:

• hrHPV detection was significantly higher in self-collected samples (52.9%) versus clinician-collected (37.2%).
• The COARI® device demonstrated 100% sensitivity and 100% negative predictive value.
• Overall agreement between methods was 84.3%, with discordant cases favoring self-sampling.

Conclusions:

• The COARI® self-sampling device is reliable and effective for hrHPV detection and partial typing.
• This device has strong potential to enhance cervical cancer screening access and coverage in Brazil.
• Further validation in larger, diverse populations is recommended for public health implementation.