Performance of HPV Self-Sample Collected by a Novel Kit in Comparison with Clinician Collected Sample for Cervical...

Area of Science:

• Gynecology
• Oncology
• Infectious Diseases

Background:

• Cervical cancer screening relies on accurate Human Papillomavirus (HPV) testing.
• Clinician-collected samples are the current standard, but self-sampling offers a potentially more accessible alternative.
• Novel HPV testing kits aim to improve screening accessibility and patient comfort.

Purpose of the Study:

• To evaluate the performance of a novel HPV self-sampling kit (CERVICHECKTM) against clinician-collected samples for cervical cancer screening.
• To assess the agreement between self-collected and clinician-collected samples for high-risk HPV detection.
• To determine the acceptability of HPV self-sampling among women.

Main Methods:

• 156 eligible women aged 25-60 with recent positive screening results were enrolled.
• Each participant provided two samples: one self-collected vaginal sample using CERVICHECKTM and one clinician-collected cervical sample.
• Samples were analyzed for high-risk HPV using the cobas HPV test and for liquid-based cytology.

Main Results:

• The agreement between CERVICHECKTM self-samples and clinician-collected samples for any high-risk HPV was 95.1% (k=0.90).
• Agreement for HPV types 16 or 18 specifically was also high at 95.1% (k=0.88).
• Over 90% of participants found self-sampling easy and were willing to recommend the kit, indicating high acceptability.

Conclusions:

• The CERVICHECKTM HPV self-sampling kit shows excellent agreement with clinician-collected samples, suggesting its potential as a reliable screening tool.
• High participant acceptability and ease of use support the potential for self-sampling to improve cervical cancer screening uptake.
• HPV self-sampling offers a promising, patient-centered approach to cervical cancer prevention programs.