Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jan;95(1):e28417.
doi: 10.1002/jmv.28417.

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

Sharonjit K Dhillon  1 , Clementina E Cocuzza  2 , Pui Yan Jenny Chung  1 , Marianna Martinelli  2 , Chiara Giubbi  2 , Ruth C Njoku  2 , Ramya Bhatia  3   4 , Kate Cuschieri  3   4 , Marc Arbyn  1   5
Affiliations

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

Sharonjit K Dhillon et al. J Med Virol. 2023 Jan.

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.

Keywords: HPV genotyping; OncoPredict HPV®; VALGENT; cervical cancer; human papillomavirus; test validation.

PubMed Disclaimer

Conflict of interest statement

C. E. C. is a minority shareholder of Hiantis Srl and received research grants and/or gratis consumables from Beckton Dickinson, Copan Italia, Seegene, Novosanis and Fujirebio. C. E. C. has received speaker honoraria and/or travel funds from Seegene, Beckton Dickinson, Copan Italia. C. E. C. is a minority shareholder of Hiantis Srl. K. C. and R. B.'s institution has received research funding or gratis consumables to support research from the following commercial entities in the last 3 years: Cepheid, Roche, Abbott, Euroimmun, GeneFirst, SelfScreen, Hiantis, Seegene and Hologic.

Figures

Figure 1
Figure 1
Flowchart of samples and testing of the OncoPredict HPV® SCR assay using the VALGENT‐2 panel
See this image and copyright information in PMC

References

    1. International Agency forResearch on Cancer . Cervical Cancer Screening. IARC Handbooks of Cancer Prevention . Vol 18. IARC Publications. https://publications.iarc.fr/604
    1. Martin CM, O'Leary JJ. Histology of cervical intraepithelial neoplasia and the role of biomarkers. Best Pract Res Clin Obstet Gynaecol. 2011;25(5):605‐615. 10.1016/j.bpobgyn.2011.04.005 - DOI - PubMed
    1. International Agency for Research on Cancer . Human Papillomaviruses. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 90. Vol 90. IARC Press; 2007.
    1. Bouvard V, Baan R, Straif K, et al. A review of human carcinogens—Part B: biological agents. Lancet Oncol. 2009;10(4):321‐322. 10.1016/s1470-2045(09)70096-8 - DOI - PubMed
    1. Arbyn M, Ronco G, Anttila A, et al. Evidence regarding human papillomavirus testing in secondary prevention of cervical cancer. Vaccine. 2012;30(suppl 5):F88‐F99. 10.1016/j.vaccine.2012.06.095 - DOI - PubMed

Publication types