Impact of Hepatitis C Virus (HCV) Genotypes on Quantification of HCV RNA in Serum by COBAS AmpliPrep/COBAS TaqMan HCV Test, Abbott HCV RealTime Assay, and VERSANT HCV RNA Assay

Tuaillon, Édouard; Mondain, Anne-Marie; Ottomani, Laure; Roudière, Laurent; Perney, Pascal; Picot, Marie‐Christine; Séguret, Fabienne; Blanc, F; Larrey, Dominique; Perre, Philippe Van de; Ducos, J

doi:10.1128/jcm.01922-07

Cited by 6 publications

(10 citation statements)

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“…In addition, the negative bias of results from the CAP-CTM assay compared to those from the ART assay that we described is consistent with most (14-16), although not all (2, 17), published studies. The basis for this difference in absolute VL is unknown but reinforces recommendations to use a single assay that can accurately quantify HCV genotypes when comparisons between measurements are clinically important, such as longitudinal sampling over time for individual patients.Previous studies have noted a bias in VL results from specific genotypes or subtypes between assays (4,10,17,20,22). Our observations of a tendency for the ART assay to give higher results with genotype 4 and lower VL results with subtype 1b, compared to the CAP-CTM assay, are similar to those reported by others (9,11,20,22).…”

supporting

confidence: 80%

“…Previous studies have noted a bias in VL results from specific genotypes or subtypes between assays (4,10,17,20,22). Our observations of a tendency for the ART assay to give higher results with genotype 4 and lower VL results with subtype 1b, compared to the CAP-CTM assay, are similar to those reported by others (9,11,20,22).…”

supporting

confidence: 80%

“…Our observations of a tendency for the ART assay to give higher results with genotype 4 and lower VL results with subtype 1b, compared to the CAP-CTM assay, are similar to those reported by others (9,11,20,22). However, in our study as well as others, individual outliers of many genotypes have been observed, and generalization to all specimens of any particular subtype or genotype is not warranted.…”

supporting

confidence: 61%

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Performance of the Abbott RealTime and Roche Cobas TaqMan Hepatitis C Virus (HCV) Assays for Quantification of HCV Genotypes

et al. 2012

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We evaluated the Abbott RealTime (ART) and Roche Cobas TaqMan Hepatitis C virus (HCV) viral load assays for quantification of HCV genotypes in patient specimens. The ART HCV assay was a more sensitive and precise tool for accurate HCV viral load quantification across the HCV genotypes tested, especially genotype 1b. Hepatitis C virus (HCV) infection is associated with significant liver-related morbidity and mortality around the world. The World Health Organization estimates that 3% of the global population is infected with HCV and that there are approximately 170 million people at risk of developing cirrhosis or hepatocarcinoma (23,24). Treatment of HCV infection typically consists of pegylated interferon plus ribavirin or pegylated interferon, ribavirin, and a direct-acting antiviral (DAA) protease inhibitor (triple therapy) for non-genotype 1 and genotype 1, respectively (11,12,13). Depending on the particular treatment regimen and the genotype of HCV, treatment success as measured by failure to detect viral replication 24 weeks after cessation of treatment can be achieved in 50 to 80% of patients (12).Measurement of HCV viral load (VL) for the different HCV genotypes is crucial to clinical management of HCV-infected patients, both treated and not, for disease staging, decisions regarding treatment initiation, and individualization of treatment strategy (i.e., dosage and duration based on response kinetics) (1,6,7,13). Furthermore, with the advent of DAAs, VL monitoring may help prevent protease inhibitor resistance development by allowing for switching or stopping therapy if VL does not decrease or returns while on treatment.There are currently several commercially available HCV VL assays; real-time PCR assays are generally preferred because of their wide dynamic ranges and good sensitivities (1, 3). Two commercial real-time PCR platforms are available, the Cobas AmpliPrep/Cobas TaqMan HCV assay version 1.0 (CAP-CTM; Roche Molecular Systems, Pleasanton, CA) and the Abbott RealTime HCV assay (ART; Abbott Molecular, Des Plaines, IL). We characterized the performance of the ART assay and compared results obtained with both assays using clinical specimens of diverse HCV genotypes in a university hospital central testing laboratory.HCV VL was determined with the ART and the CAP-CTM as per the manufacturers' recommendations. A serum specimen volume of 500 l was required for ART, compared to 850 l for CAP-CTM. Sample preparation for the ART assay was performed using the Abbott m2000sp instrument. HCV genotypes were identified using the Versant Inno-LIPA HCV Genotype 2.0 assay (Siemens Healthcare Diagnostics, Deerfield, IL); specimens with indeterminate results were tested with the RealTime Genotyping II RUO assay (Abbott Molecular, Des Plaines, IL) or by direct sequencing and phylogenetic analysis of NS5B (performed by Siemens Clinical Laboratories, Berkeley, CA). Statistical tests were performed using Prism 5.0 (GraphPad Software, La Jolla, CA).To evaluate the sensitivity, linearity, and intra-and interrun precisio...

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supporting

confidence: 80%

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confidence: 80%

supporting

confidence: 61%

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Performance of the Abbott RealTime and Roche Cobas TaqMan Hepatitis C Virus (HCV) Assays for Quantification of HCV Genotypes

et al. 2012

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“…[30][31][32][35][36][37][38] Our aim was not to determine which assay was better than another in a clinical setting. Our goal was to evaluate the clinical relevance of these assays for determining RVR and EVR.…”

Section: Discussionmentioning

confidence: 99%

Clinical performances of two real-time PCR assays and bDNA/TMA to early monitor treatment outcome in patients with chronic hepatitis C

Martinot–Peignoux

Khiri

Leclere

et al. 2009

Journal of Clinical Virology

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“…This is illustrated by the failure of existing NAT to detect rare HIV mutants [10], specific HCV genotypes [11] and, more frequently reported, viral load assays that sub and overquantify particular genotypes of HCV and HIV [12,13].…”

Section: Nat False-negatives/positivesmentioning

confidence: 99%

Current concepts in molecular testing

Levi

2011

ISBT Science Series

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Impact of Hepatitis C Virus (HCV) Genotypes on Quantification of HCV RNA in Serum by COBAS AmpliPrep/COBAS TaqMan HCV Test, Abbott HCV RealTime Assay, and VERSANT HCV RNA Assay

Cited by 6 publications

References 0 publications

Performance of the Abbott RealTime and Roche Cobas TaqMan Hepatitis C Virus (HCV) Assays for Quantification of HCV Genotypes

Performance of the Abbott RealTime and Roche Cobas TaqMan Hepatitis C Virus (HCV) Assays for Quantification of HCV Genotypes

Clinical performances of two real-time PCR assays and bDNA/TMA to early monitor treatment outcome in patients with chronic hepatitis C

Current concepts in molecular testing

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