Principles and analytical performance of Papilloplex® HR-HPV， a new commercial CE-IVD molecular diagnostic test for the detection of high-risk HPV genotypes.

The accurate detection and genotyping of high-risk human papillomavirus (HR-HPV) are critical for cervical cancer screening and epidemiological investigations. GeneFirst Papilloplex® HR-HPV is a new CE-IVD-marked real-time PCR test based on patented multiplex probe amplification technology. Papilloplex® HR-HPV provides the simultaneous detection and differentiation of 14 HR-HPV genotypes (16， 18， 31， 33， 35， 39， 45， 51， 52， 56， 58， 59， 66， and 68a/b) in a single closed-tube reaction ensuring rapid， cost-effective， and contamination-free results. In this study， the analytical performance characteristics in terms of the assay's sensitivity， specificity， range， reproducibility， and cross-reactivity were evaluated. Papilloplex® HR-HPV provided sensitive detection and differentiation of 14 HR-HPV types with highly reproducible results. The differential HR-HPV specificity and sensitivity were further confirmed through the participation in the WHO HPV Laboratory Network Proficiency Study (2014). Overall， GeneFirst Papilloplex® HR-HPV assay demonstrated a robust analytical performance with reproducible and reliable results in the detection of HR-HPV genotypes.