Principles and analytical performance of Papilloplex® HR-HPV, a new commercial CE-IVD molecular diagnostic test for the detection of high-risk HPV genotypes
| Autor: | Giorgos K. Sakellariou, Michal Bilski, Martin Stofanko, Guoliang Fu, Melanie Moreau, Yibin Liu, Elena Boland, Marcus Harrison, Devarshi Kapadia |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Microbiology (medical) Genotype 030106 microbiology Computational biology Biology Real-Time Polymerase Chain Reaction Cervical intraepithelial neoplasia Sensitivity and Specificity 03 medical and health sciences 0302 clinical medicine medicine Humans Multiplex 030212 general & internal medicine Papillomaviridae Genotyping Early Detection of Cancer Cervical cancer Reproducibility Papillomavirus Infections Reproducibility of Results virus diseases General Medicine medicine.disease Molecular diagnostics female genital diseases and pregnancy complications Infectious Diseases Molecular Diagnostic Techniques High risk hpv DNA Viral Female Reagent Kits Diagnostic |
| Zdroj: | Diagnostic Microbiology and Infectious Disease. 95:46-54 |
| ISSN: | 0732-8893 |
| DOI: | 10.1016/j.diagmicrobio.2019.04.005 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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