A Randomized Comparison of Different Vaginal Self-sampling Devices and Urine for Human Papillomavirus...

Area of Science:

• Gynecology
• Oncology
• Virology

Background:

• Cervical cancer screening is transitioning from cytology to human papillomavirus (HPV)-based methods.
• HPV testing offers higher sensitivity and can utilize self-collected vaginal or urine samples.
• Self-sampling enhances accessibility and patient comfort in cervical screening programs.

Purpose of the Study:

• To compare the high-risk HPV positivity rates and sensitivity of various self-collection devices for vaginal samples.
• To evaluate the performance of urine-based HPV testing against vaginal self-sampling methods.
• To assess women's experience and confidence with different self-sampling devices.

Main Methods:

• 620 women undergoing colposcopy provided urine samples (Colli-Pee) and vaginal self-samples using specified devices (dry flocked swab, wet dacron swab, HerSwab, Qvintip).
• HPV testing was conducted using the BD Onclarity HPV Assay.
• Analysis included positivity rates and sensitivity for CIN2+ and CIN3+ based on sample type and device.

Main Results:

• Vaginal self-sampling with dry flocked (DF) and wet dacron (WD) swabs, along with urine samples, demonstrated similar HPV positivity rates and sensitivity for CIN2+ and CIN3+.
• The Qvintip (QT) and HerSwab (HS) devices showed lower positivity rates and sensitivity compared to DF, WD, and urine.
• Women reported urine as the easiest sample to collect, with higher confidence, while HS collection yielded the lowest confidence.

Conclusions:

• Urine, DF, and WD vaginal self-sampling methods are effective and well-accepted for high-risk HPV detection in cervical screening.
• QT and HS devices were found to be less satisfactory for self-collection.
• The study supports the expanded implementation of urine or vaginal self-sampling for improved cervical cancer screening.