HPValidate - Technical optimisation of self-collected samples for HPV testing within the NHS England cervical...

Area of Science:

• Gynecologic Oncology
• Molecular Diagnostics
• Public Health Screening

Background:

• The English NHS cervical screening programme is evaluating vaginal human papillomavirus (HPV) self-sampling.
• Standardized testing protocols for HPV self-sampling workflows are currently lacking.
• Pre-analytical and analytical factors influencing HPV test accuracy require investigation.

Purpose of the Study:

• To assess technical factors across five distinct HPV self-sampling workflows.
• To compare self-collected samples with clinician-collected samples as a reference standard.
• To identify determinants of invalid HPV test results and evaluate sample stability.

Main Methods:

• Evaluation of five workflows using Roche cobas HPV DNA and Hologic APTIMA HPV mRNA assays.
• Utilized Rovers Evalyn® Brush, Copan FLOQSwabs®, and Hologic Multitest kit for sample collection.
• Assessed sample acceptance, invalid rates, interference factors (blood, microbial growth, age), and time from collection to resuspension.

Main Results:

• One workflow showed a 5.6% invalid rate for self-collected samples, compared to 0% for clinician-collected samples.
• Time from self-sample collection to resuspension emerged as a key factor influencing invalid results.
• Post-resuspension, samples demonstrated high stability with 89.4%-100% reproducibility.

Conclusions:

• Laboratory workflows, acceptance criteria, and standardized protocols for HPV self-sampling need optimization.
• Addressing pre-analytical variables like sample processing time is essential for reliable HPV detection.
• HPV self-sampling offers a viable option for cervical screening when technical factors are carefully managed.