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Evaluation of the clinical performance of OncoPredict HPV® SCR assay within the VALGENT-2 framework.

Dhillon, Sharon
Cocuzza, Clementina E.
Chung, Pui Yan Jen
Martinelli, Marianna
Giubbi, Chiara
Njoku, Ruth C.
Bhatia, Ramya
Cuschieri, Kate
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Abstract

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.

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2023-01-01
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Peer reviewed scientific article
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Early Detection of Cancer, Female, Genotyping Techniques, Human Papillomavirus Viruses, Humans, Papillomaviridae, Papillomavirus Infections, Real-Time Polymerase Chain Reaction, Reproducibility of Results, Sensitivity and Specificity, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
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