Analytical performance of the VERIS MDx system HCV assay for detecting and quantifying HCV RNA
| Autor: | Jacques Izopet, Florence Abravanel, Karine Sauné, J. Boineau, Catherine Mengelle, Catherine Haslé |
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| Rok vydání: | 2016 |
| Předmět: |
Serial dilution
Genotype Hepatitis C virus Blood Donors Hepacivirus Biology Immunologic Tests medicine.disease_cause World Health Organization Polymerase Chain Reaction Sensitivity and Specificity 03 medical and health sciences Plasma 0302 clinical medicine Limit of Detection Virology medicine Humans Viral rna 030212 general & internal medicine Detection limit Reproducibility of Results Reference Standards Viral Load Molecular biology Hepatitis C Infectious Diseases RNA Viral 030211 gastroenterology & hepatology Reagent Kits Diagnostic |
| Zdroj: | Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology. 84 |
| ISSN: | 1873-5967 |
| Popis: | Background The diagnosis of HCV relies on the detection of viral RNA. Objective To evaluate the performance of the VERIS/MDx System HCV Assay, a new automated system for quantifying HCV RNA, and to compare with the COBAS® Ampliprep/COBAS® Taqman™ (CAPCTM) HCV Test version 2.0. Study design The limit of detection was determined by Probit analysis with the 3rd International WHO HCV standard and precision by assaying in duplicate control samples with HCV RNA concentrations of 7.9; 5.0; 3.4; 1.6 and 0 log IU/ml over 20 days. Analytical specificity was assessed by assaying 180 samples from negative anti-HCV and HCV RNA blood donors and linearity with replicates of serial dilutions of a clinical plasma (6.4–0.6 log IU/ml). We compared the VERIS MDx HCV and CAPCTM HCV assays by testing 209 samples. Results The limit of detection was 6.1 IU/ml [CI 95%: 5.0–8.3] and the precision, given by the standard deviation, was ≤0.11 log IU/ml. Specificity was 100%. The linearity ranged from 1.5 to 6.4 log IU/ml. Passing-Bablok regression analysis gave: VERIS log IU/ml = −0.33 + [1.04× CAPCTM] log IU/ml, with biases for the 25th, 50th, 75th percentiles of 0.18, −0.10 and −0.06 log IU/ml. The two assays were well correlated (ρ = 0.92, p Conclusion The VERIS MDx HCV assay performed well. But, we observed an under-quantification of the genotype 4 samples. |
| Databáze: | OpenAIRE |
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