The New Aptima HCV Quant Dx Real-time TMA Assay Accurately Quantifies Hepatitis C Virus Genotype 1-6 RNA
| Autor: | Fabienne Dubernet, Claude Dauvillier, Christophe Hézode, Stéphane Chevaliez, Jean-Michel Pawlotsky |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Genotype Hepatitis C virus 030106 microbiology HCV genotypes Single step Hepacivirus Nucleic Acid Testing Biology Real-Time Polymerase Chain Reaction medicine.disease_cause Sensitivity and Specificity 03 medical and health sciences Limit of Detection Virology Hepatitis C virus genotype medicine Humans Reproducibility of Results virus diseases RNA Hepatitis C Chronic Viral Load Serum samples digestive system diseases Data Accuracy Clinical Practice Infectious Diseases RNA Viral Reagent Kits Diagnostic |
| Zdroj: | Journal of Clinical Virology. 91:5-11 |
| ISSN: | 1386-6532 |
| Popis: | Background Sensitive and accurate hepatitis C virus (HCV) RNA detection and quantification is essential for the management of chronic hepatitis C therapy. Currently available platforms and assays are usually batched and require at least 5 hours of work to complete the analyses. Objectives and study design The aim of this study was to evaluate the ability of the newly developed Aptima HCV Quant Dx assay that eliminates the need for batch processing and automates all aspects of nucleic acid testing in a single step, to accurately detect and quantify HCV RNA in a large series of patients infected with different HCV genotypes. Results The limit of detection was estimated to be 2.3 IU/mL. The specificity of the assay was 98.6% (95% confidence interval: 96.1%-99.5%). Intra-assay and inter-assay coefficients of variation ranged from 0.09% to 5.61%, and 1.05% to 3.65%, respectively. The study of serum specimens from patients infected with HCV genotypes 1 to 6 showed a satisfactory relationship between HCV RNA levels measured by the Aptima HCV Quant Dx assay, and both real-time PCR comparators (Abbott RealTime HCV and Cobas AmpliPrep/Cobas TaqMan HCV Test, version 2.0, assays). Conclusions the new Aptima HCV Quant Dx assay is rapid, sensitive, reasonably specific and reproducible and accurately quantifies HCV RNA in serum samples from patients with chronic HCV infection, including patients on antiviral treatment. The Aptima HCV Quant Dx assay can thus be confidently used to detect and quantify HCV RNA in both clinical trials with new anti-HCV drugs and clinical practice in Europe and the US. |
| Databáze: | OpenAIRE |
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