Analytical and clinical performance of OncoPredict HPV Screening (SCR)
assay on self-collected vaginal and urine specimens within the VALHUDES
Framework
Abstract
The introduction of self-sampling in cervical cancer screening has
raised the importance of HPV testvalidation on self-collected samples.
This study aimed to evaluate the clinical performance of the OncoPredict
HPV Screening (SCR) assay on self-collected vaginal and first-void urine
(FVU) as part of the VALHUDES framework. Vaginal (FLOQSwabs) and FVU
(Colli-Pee) samples were self-collected by 500 women referred to
colposcopy, followed by a clinician-collected cervical sample prior to
colposcopy, which were all tested using OncoPredict HPV SCR. OncoPredict
HPV SCR demonstrated similar relative clinical sensitivity to detect
cervical intraepithelial neoplasia grade 2 or worse (≥ CIN2) in urine
(ratio: 0.95 [95%CI 0.88-1.02]) and vaginal self-samples (ratio:
0.96 [95%CI 0.90-1.02]) compared to cervical samples. The clinical
specificity was lower in vaginal but not in urine samples compared to
cervical which improved following cut-off optimization. A higher
cellularity was found in vaginal as compared to cervical and FVU
samples. Moderate to excellent agreement in HPV detection in
self-collected samples and cervical scrapes was demonstrated (Kappa
values: 0.53 to 1.00). OncoPredict HPV SCR assay demonstrated similar
accuracy on self-collected vaginal and FVU samples compared to cervical
samples, although cut-off adjustment improved clinical specificity when
applied to vaginal samples.