Evaluation of the clinical performance of OncoPredict HPV® SCR assay within the VALGENT-2 framework.
J Med Virol
; 95(1): e28417, 2023 01.
Article
in En
| MEDLINE
| ID: mdl-36541733
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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Uterine Cervical Dysplasia
/
Uterine Cervical Neoplasms
/
Papillomavirus Infections
Type of study:
Diagnostic_studies
/
Prognostic_studies
/
Screening_studies
Limits:
Female
/
Humans
Language:
En
Journal:
J Med Virol
Year:
2023
Document type:
Article
Affiliation country:
Belgium