Validation of BD onclarity HPV assay on vaginal self-samples versus cervical samples using the VALHUDES protocol

BACKGROUND In this study, we evaluated accuracy of HPV testing on self-samples versus clinician-taken samples through the VALHUDES protocol. VALHUDES was designed as a diagnostic test accuracy study, where women referred to colposcopy collected self-samples followed by clinician-taken cervical samples. METHODS Four hundred eighty-five women recruited in five colposcopy clinics (median age 40 years; IQR 31-49) with valid results for all specimens were included in the main analysis: 230 vaginal self-samples were collected with Evalyn Brush and 255 with Qvintip. Cervical samples were taken by the gynaecologist with the Cervex-Brush. HPV testing was performed with BD Onclarity™ HPV assay (Onclarity). Colposcopy and histology were used as the reference standard for accuracy estimation. RESULTS The sensitivity for CIN2+ on vaginal self-samples overall was not different from cervical samples (ratio=0.96 [95%CI 0.90-1.03]), while specificity was significantly higher (ratio=1.09 [95% CI 1.02-1.16]). However, the relative accuracy (self- vs clinician sampling) differed by vaginal collection device: relative sensitivity and specificity ratios of 1.00 [95% CI 0.94-1.06] and 1.15 [95% CI 1.05-1.25], respectively for Evalyn-Brush; 0.91 [95% CI 0.79-1.04] and 1.03 [95%CI 0.95-1.13], respectively for Qvintip. CONCLUSION Clinical accuracy of BD Onclarity HPV assay on vaginal self-samples was not different from cervical samples. IMPACT VALHUDES study showed that HPV testing with Onclarity HPV on vaginal self-samples is similarly sensitive compared to cervical specimens. However, differences in accuracy by self-sampling devices, although not significant, were noted. Onclarity HPV testing on vaginal self-samples following validated collection and handling procedures may be used in primary cervical cancer screening.

Jaar van publicatie:2023

Trefwoorden:A1 Journal article

Toegankelijkheid:Open