Establishment of standard panels consisting 14 high - risk HPV types for evaluation of HPV realtime-PCR based diagnostics

Abstract

Human papillomavirus (HPV), including 14 high - risk HPV types are associated with more than 99% of cervical cancer cases. This study aims to develop relevant standard panels in order to establish and evaluate realtime based diagnostic test. In this study, these standard panels were established from 14 recombinant plasmids and clinical samples of known HPV genotypes. Samples within the panels were confirmed by PCR with specific primer PGMY09/ PGMY11 and by the 2 commercial kits. We established 4 standard panels for accessing (i) a panel for clinical sensitivity with 60 clinical samples of 14 high risk HPV genotypes, (ii) a panel for analytical sensitivity with different concentrations of 14 plasmids expressing HPV genes (iii) a panel for specificity including 103 HPV-negative clinical samples, and (iv) a panel for accuracy consisting of samples with 4 different concentrations of 14 genotypes. Two independent laboratories evaluated these panels and gave a consistent result. This is the first established and published standard panel for 14 high-risk HPV genotypes in Vietnam.