Validation of BD Onclarity HPV Assay on Vaginal Self-Samples versus Cervical Samples Using the VALHUDES Protocol

• Published in: Cancer epidemiology, biomarkers & prevention biomarkers & prevention, 2022-12, Vol.31 (12), p.2177-2184
• Main Authors: Latsuzbaia, Ardashel, Vanden Broeck, Davy, Van Keer, Severien, Weyers, Steven, Donders, Gilbert, Doyen, Jean, Tjalma, Wiebren, De Sutter, Philippe, Peeters, Eliana, Vorsters, Alex, Arbyn, Marc
• Format: Article
• Language: English
• Subjects: Adult; Early Detection of Cancer - methods; Female; Humans; Papillomaviridae; Papillomavirus Infections; Sensitivity and Specificity; Specimen Handling - methods; Uterine Cervical Dysplasia; Uterine Cervical Neoplasms; Vaginal Smears
• ISSN: 1055-9965; 1538-7755
• DOI: 10.1158/1055-9965.EPI-22-0757

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. 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 gynecologist 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. The sensitivity for CIN2+ on vaginal self-samples overall was not different from cervical samples (ratio = 0.96; 95% CI, 0.90-1.03), whereas 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. Clinical accuracy of BD Onclarity HPV assay on vaginal self-samples was not different from cervical samples. VALHUDES study showed that HPV testing with Onclarity HPV on vaginal self-samples is similarly sensitive compared with 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.