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.

Dhillon, S., Cocuzza, C., Chung, P., Martinelli, M., Giubbi, C., Njoku, R., et al. (2023). Evaluation of the clinical performance of OncoPredict HPV® SCR assay within the VALGENT-2 framework. JOURNAL OF MEDICAL VIROLOGY, 95(1 (January 2023)) [10.1002/jmv.28417].

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

Cocuzza, Clementina E
Secondo
;
Martinelli, Marianna;Giubbi, Chiara;
2023

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.
Articolo in rivista - Articolo scientifico
cervical cancer; HPV genotyping; human papillomavirus; OncoPredict HPV®; test validation; VALGENT;
English
21-dic-2022
2023
95
1 (January 2023)
e28417
none
Dhillon, S., Cocuzza, C., Chung, P., Martinelli, M., Giubbi, C., Njoku, R., et al. (2023). Evaluation of the clinical performance of OncoPredict HPV® SCR assay within the VALGENT-2 framework. JOURNAL OF MEDICAL VIROLOGY, 95(1 (January 2023)) [10.1002/jmv.28417].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/404297
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