EUROArray HPV test accuracy for cervical precancer in self- vs. clinician-collected samples using the VALHUDES protocol

Abstract

Objective

Human papillomavirus (HPV) testing on self-collected urine and vaginal samples has shown great potential for cervical cancer screening by offering a non-invasive and approachable alternative to un(der)screened populations. Although many HPV tests were validated on cervical samples, data regarding clinical performance on self-samples is warranted prior to its clinical use.

Methods

The VALHUDES framework was designed to evaluate the accuracy of HPV tests on self-samples. As such, five colposcopy clinics enrolled patients with aberrant cervical results, asking them to collect a first-void urine (Colli-Pee) and a vaginal self-sample (Evalyn Brush or Qvintip). Additionally, a clinician-collected cervical sample was collected as comparator. 0.4 mL of all samples was used for DNA extraction with Abbott m2000, eluting in 50 μL. To detect high-risk HPV, PCR was conducted on 5 μL DNA extract from all samples with the EUROArray HPV test. Disease outcome was determined by colposcopy with or without biopsy. Relative accuracy was estimated for each self-sample type compared to the clinician-collected sample.

Results

Data was available from 491 and 494 matched samples for vaginal and first-void urine self-samples, respectively. Relative sensitivity for CIN2+ was 0.96 (95 % CI: 0.91–1.02) for vaginal self-samples and 0.96 (95 % CI: 0.90–1.05) for first-void urine. The specificity for <CIN2 was also not significantly lower on the self-samples compared to clinician-taken samples (relative specificity: 0.98 [95 % CI: 0.91–1.07] for vaginal self-samples and 0.94 [95 % CI: 0.85–1.04] for first-void urine).

Conclusions

The accuracy of EUROArray HPV is similar on vaginal self-samples and first-void urine compared to clinician-collected cervical samples.