Performance of version 2.0 of the Cobas AmpliPrep/Cobas TaqMan real-time PCR assay for hepatitis B virus DNA quantification.

Abstract : The detection and quantification of hepatitis B virus (HBV) DNA are essential for the diagnosis and treatment of chronic HBV infection. The use of real-time PCR assays for HBV DNA quantification is strongly recommended. The goal of this study was to evaluate the intrinsic characteristics and clinical performance of version 2.0 (v2.0) of the Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) assay, a fully automated platform for HBV DNA quantification in serum or in plasma with a claimed lower limit of detection of 20 IU/ml and a claimed upper limit of quantification of 1.7 × 10(8) IU/ml. The specificity of the assay was 99% (95% confidence interval, 94.7 to 100%). Intra-assay and interassay coefficients of variation ranged from 0.21% to 2.67% and from 0.65% to 2.25%, respectively. The calibration of the assay was found to be satisfactory. Study of blood specimens from patients infected with HBV genotypes A to F showed good correspondence between HBV DNA levels measured by the CAP/CTM v2.0 assay, version 1.0 of the same assay, and the third-generation "branched DNA" assay. The CAP/CTM v2.0 assay quantified HBV DNA levels in serum or plasma from the same patients equally. In conclusion, the new version of the CAP/CTM assay is sensitive, specific, and reproducible. It accurately quantifies HBV DNA levels in patients chronically infected with HBV genotypes A to F. Improvements made to ensure equal quantification of HBV DNA in serum and plasma have been successful. Overall, the CAP/CTM assay, version 2.0, is well suited to monitoring clinical HBV DNA levels according to current clinical practice guidelines.
Type de document :
Article dans une revue
Journal of Clinical Microbiology, American Society for Microbiology, 2010, 48 (10), pp.3641-7. 〈10.1128/JCM.01306-10〉
Liste complète des métadonnées

http://www.hal.inserm.fr/inserm-00529803
Contributeur : Georges Guellaen <>
Soumis le : mardi 26 octobre 2010 - 15:58:59
Dernière modification le : mercredi 13 décembre 2017 - 14:44:03
Document(s) archivé(s) le : jeudi 27 janvier 2011 - 03:00:01

Fichiers

Identifiants

Collections

Citation

Stéphane Chevaliez, Magali Bouvier-Alias, Syria Laperche, Christophe Hézode, Jean-Michel Pawlotsky. Performance of version 2.0 of the Cobas AmpliPrep/Cobas TaqMan real-time PCR assay for hepatitis B virus DNA quantification.. Journal of Clinical Microbiology, American Society for Microbiology, 2010, 48 (10), pp.3641-7. 〈10.1128/JCM.01306-10〉. 〈inserm-00529803〉

Partager

Métriques

Consultations de la notice

187

Téléchargements de fichiers

1128