Clinical Validation of a Vaginal Cervical Cancer Screening Self-Collection Method for At-Home Use: A Nonrandomized...

Area of Science:

• Gynecology and Obstetrics
• Public Health
• Medical Devices

Background:

• Cervical cancer screening rates are suboptimal, with one-quarter of at-risk US women delaying screening.
• Current FDA-approved self-collected (SC) screening is limited to healthcare settings, necessitating an at-home option to overcome clinic-related barriers.

Purpose of the Study:

• To clinically validate an SC cervical screening device designed for at-home use, focusing on performance, safety, ease of use, and transportability.
• To assess the feasibility and patient preference for an at-home SC cervical screening method.

Main Methods:

• A nonrandomized, prospective method comparison trial involving 599 participants aged 25-65 across 16 US clinical sites.
• Participants provided both SC and clinician-collected (CC) samples, tested for high-risk human papillomavirus (hrHPV) using an FDA-approved test.
• Evaluated primary outcomes including positive and negative percentage agreement for hrHPV detection, clinical sensitivity for high-grade cervical dysplasia, and device usability.

Main Results:

• The SC method demonstrated a positive percentage agreement of 95.2% for hrHPV detection compared to CC samples.
• Clinical sensitivity for high-grade cervical dysplasia was 95.8% with the SC method, equivalent to CC samples.
• Over 92% of participants found the device easy to use and preferred SC screening if results were comparable to CC screening.

Conclusions:

• At-home SC cervical screening using the validated device is clinically effective, demonstrating high performance comparable to clinician-collected samples.
• The SC method is user-friendly and preferred by patients, offering a viable solution to increase cervical cancer screening accessibility.
• This approach holds significant potential for at-home cervical cancer screening, addressing barriers to timely and regular screening.