Human Papillomavirus Genotype Detection and Cytology Using a New Self-Sampling Method.

Area of Science:

• Gynecologic Oncology
• Molecular Diagnostics
• Public Health Screening

Background:

• Dry-type self-sampling for high-risk human papillomavirus (hrHPV) is increasing global screening uptake.
• Current hrHPV triage often necessitates a clinical visit for reflex cytology, creating a barrier.
• Novel self-sampling methods are needed to integrate hrHPV detection and cytology.

Purpose of the Study:

• To evaluate the hrHPV detection capability of the CellSoft® wet-type self-sampling device.
• To assess the feasibility of performing cytology on CellSoft® samples.
• To compare hrHPV detection between CellSoft® and the Evalyn® Brush.

Main Methods:

• Thirty-eight women aged 20+ self-collected vaginal specimens using CellSoft® and Evalyn® Brush.
• Polymerase chain reaction (PCR)-based HPV genotyping was performed on both specimen types.
• Cytological examination was conducted on CellSoft® samples.

Main Results:

• Overall agreement for hrHPV detection between CellSoft® and Evalyn® Brush was high at 97.4%.
• Evalyn® Brush detected a greater number of hrHPV genotypes compared to CellSoft®.
• Among 22 hrHPV-positive CellSoft® samples, 47.6% showed atypical squamous cells of undetermined significance or worse.

Conclusions:

• CellSoft® demonstrates good agreement with Evalyn® Brush for hrHPV detection.
• The CellSoft® device yields adequate cellular material for both HPV testing and cytological evaluation.
• CellSoft® offers a promising integrated approach for hrHPV screening and triage.