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Real-Time PCR Assays for the Quantification of HCV RNA: Concordance,Discrepancies and Implications for Response Guided Therapy
Authors:Robert Strassl  Karoline Rutter  Albert Friedrich St?ttermayer  Sandra Beinhardt  Michael Kammer  Harald Hofer  Peter Ferenci  Theresia Popow-Kraupp
Affiliation:1. Department of Laboratory Medicine, Division of Clinical Virology, Medical University of Vienna, Vienna, Austria.; 2. Department of Internal Medicine III, Division of Gastroenterology & Hepatology, Medical University of Vienna, Vienna, Vienna, Austria.; 3. Center for Medical Statistics, Informatics, and Intelligent Systems (CeMSIIS), Medical University of Vienna, Vienna, Austria.; University of the Witwatersrand, SOUTH AFRICA,
Abstract:

Background and Aims

Monitoring of chronic Hepatitis C (CHC) treatment relies on HCV RNA quantification by means of real-time PCR methods. Assay specific analytical sensitivities may impact therapy management.

Methods

Comparative analysis between three commercial assays (Roche COBAS AmpliPrep/COBAS TaqMan Version 1 (CAP/CTM Ver. 1), Version 2 (CAP/CTM Ver. 2) and the Abbott RealTime HCV (ART) assay) was performed on 247 available samples taken at key decision time points during antiviral therapy of 105 genotype 1 patients (triple therapy: n = 70; dual therapy: n = 35).

Results

Overall concordance of HCV RNA measurements was high between the two Roche systems (89%; n = 220/247) but lower between the Roche assays and the ART (CAP/CTM Ver. 1 vs ART: 77.3%; n = 191/247 and CAP/CTM v.2 vs ART: 80.1%; n = 198/247). Most discrepancies were noted in week 4/8 samples with residual viremia (ConclusionAn abbreviated course of treatment can safely be applied in patients with residual viremia (
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