Performance of the Abbott Real-Time PCR Assay Using m 2000 _sp and m 2000 _rt for Hepatitis C Virus RNA Quantification

Abstract

Quantification of hepatitis C virus (HCV) RNA is essential for the everyday management of chronic hepatitis C therapy. "Real-time" PCR techniques are potentially more sensitive than classical PCR techniques, are not prone to carryover contamination, and have a consistently wider dynamic range of quantification. Thus, they are rapidly replacing other technologies for routine quantification of HCV RNA. We extensively evaluated the intrinsic characteristics and clinical performance of the m2000 sp -m2000 rt Abbott real-time PCR platform for HCV RNA quantification. The study shows that the m2000 sp -m2000 rt platform is sensitive, specific, and precise; that the results are reproducible; and that the platform has a broad dynamic range of quantification. When comparing HCV RNA levels measured in the same individuals with the m2000 sp -m2000 rt platform and the third-generation branched-DNA assay, a trend toward a modest overestimation of HCV RNA levels was observed in the m2000 sp -m2000 rt platform in all genotypes except genotype 5. The differences, however, were unlikely to have any impact in clinical practice. In conclusion, our study shows that the Abbott m2000 real-time PCR system for HCV RNA quantification is sensitive, specific, and precise; that the results are reproducible; and that the platform's broad dynamic range of quantification is well suited to HCV RNA monitoring in the clinical setting.Monitoring of hepatitis C virus (HCV) RNA levels is essential for the management of chronic hepatitis C therapy with the combination of pegylated alpha interferon and ribavirin. Indeed, the rapid (undetectable HCV RNA at week 4 of therapy) and early (more than 2 log 10 drop or undetectable HCV RNA at week 12 of therapy) virologic response is a strong predictor of the likelihood of sustained viral eradication and is used to tailor the treatment duration and to improve cure rates (2,6,7,10,14,16,23,26,27). HCV RNA quantification will continue to be of major importance in the management of therapy with the new HCV drugs in development to assess the virologic response and to detect virologic breakthroughs related to viral resistance early enough to alter therapy and rescue antiviral efficacy (20).Ideally, HCV RNA quantification assays should be sensitive, specific, accurate, and precise, and the results should be reproducible. They should have a broad range of linear quantification that fully covers the HCV RNA levels observed in clinical practice in both untreated and treated patients, and quantification should be independent of the HCV genotype. Real-time PCR techniques currently are replacing classical PCR methods and the branched-DNA (bDNA) technology, which did not fulfill all of these criteria. Real-time PCR methods are sensitive, with lower limits of detection/quantification on the order of 10 to 15 HCV RNA international units (IU)/ml, and are not prone to carryover contamination. They benefit from a broad dynamic range of quantification of 7 to 8 log 10 units that covers most of the HCV RNA levels encountered in ...

European Multicenter Study on Analytical Performance of DxN Veris System HCV Assay

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“…The SDs and % CVs were comparable with those seen with other approved HCV assays (9)(10)(11)(12)(13)(14). In this evaluation, within-run, between-lot, and between-site variability contributed most to the total imprecision seen.…”

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

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A Correlative Study on Hepatitis C Virus Load Determined by Real Time Polymerase Chain Reaction with Serum Biomarkers in Patients with Renal Disease

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