Large-Scale Study Comparing Analytical and Diagnostic Quality of Three HPV Self-Sampling Devices for At-Home Cervical...

Area of Science:

• Gynecology
• Public Health
• Molecular Diagnostics

Background:

• Cervical cancer elimination necessitates widespread screening participation.
• Self-sampling devices offer improved accessibility but require validation for sample quality.
• Independent validation of self-sampling devices is limited.

Purpose of the Study:

• To compare the sample quality and HPV detection rates of three distinct self-sampling devices.
• To evaluate the analytical and diagnostic performance of HPV testing using samples from these devices.
• To inform the selection of self-sampling devices for cervical cancer screening programs.

Main Methods:

• A comparative study involving 1677 women in Denmark undergoing self-sampling.
• Participants received kits with combinations of three devices: Evalyn, FLOQSwab, and SensiGrip.
• Samples were analyzed for oncogenic HPV types using the BD Onclarity HPV assay.

Main Results:

• Sample quality was comparable across all three self-sampling devices, irrespective of participant age.
• The prevalence of oncogenic HPV types was 13.9% (232 women).
• High pairwise concordance (93.5%-95%) was observed between devices, indicating similar HPV detection performance.

Conclusions:

• Sample quality does not appear to be a deciding factor when choosing between Evalyn, FLOQSwab, and SensiGrip devices.
• The selection of self-sampling devices can prioritize other considerations like cost, user preference, and device ergonomics.
• These findings support the reliable use of various self-sampling technologies for HPV-based cervical cancer screening.