TY - JOUR T1 - Evaluation of the clinical performance of OncoPredict HPV® SCR assay within the VALGENT‐2 framework JF - Journal of Medical Virology Y1 - 2023 A1 - Sharon Dhillon A1 - Clementina E. Cocuzza A1 - Jenny Pui Yan Chung A1 - Marianna Martinelli A1 - Chiara Giubbi A1 - Ruth C. Njoku A1 - Bhatia, Ramya A1 - Cuschieri, Kate A1 - M. Arbyn KW - cervical cancer KW - HPV genotyping KW - human papillomavirus KW - OncoPredict HPV® KW - test validation. KW - VALGENT AB -

Human papillomavirus (HPV) assays used in cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV® Screening (SCR) is a partial genotyping multiplex real-time PCR assay targeting E6/E7 genes of 13 high-risk (hr) HPVs. OncoPredict HPV® SCR (index assay) identifies HPV-16 and HPV-18 separately, 11 other hrHPV in aggregate and includes quality controls for sample adequacy, DNA extraction efficiency and PCR inhibition. 1300 VALGENT-2 study samples (from women aged 20-60 attending the Scottish cervical cancer screening program) were tested with the index assay and the GP5+/6+ PCR enzyme immunoassay (standard comparator assay). Non-inferior accuracy detecting cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) of the index versus comparator was verified. Intra- and interlaboratory reproducibility of the index was evaluated by overall concordance and Cohen's kappa, using a sub-population (n = 526). Relative sensitivity and specificity for CIN2+ of the index versus comparator were 1.01 (95% confidence interval [CI]: 0.99-1.03) and 1.02 (95% CI: 1.0-1.04), respectively. Noninferiority p values were all ≤0.05, except for CIN3+ in patients ≥30 years. Excellent intra- and interlaboratory reproducibility was shown with concordance >98% and kappas >0.95. OncoPredict HPV® SCR fulfills the three international validation criteria for hrHPV DNA tests in cervical cancer screening.

VL - 95 CP - 1 M3 - 10.1002/jmv.28417 ER -