• Medientyp: E-Artikel
  • Titel: Expertise of Laboratories in Viral Load Quantification, Genotyping, and Precore Mutant Determination for Hepatitis B Virus in a Multicenter Study
  • Beteiligte: Laperche, Syria; Thibault, Vincent; Bouchardeau, Françoise; Alain, Sophie; Castelain, Sandrine; Gassin, Michelle; Gueudin, Marie; Halfon, Philippe; Larrat, Sylvie; Lunel, Françoise; Martinot-Peignoux, Michèle; Mercier, Bernard; Pawlotsky, Jean-Michel; Pozzetto, Bruno; Roque-Afonso, Anne-Marie; Roudot-Thoraval, Françoise; Sauné, Karine; Lefrère, Jean-Jacques
  • Erschienen: American Society for Microbiology, 2006
  • Erschienen in: Journal of Clinical Microbiology, 44 (2006) 10, Seite 3600-3607
  • Sprache: Englisch
  • DOI: 10.1128/jcm.00732-06
  • ISSN: 1098-660X; 0095-1137
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  • Beschreibung: ABSTRACTA national evaluation study was performed in 14 specialized laboratories with the objective of assessing their capacities to provide (i) hepatitis B virus (HBV) viral loads (VL), (ii) HBV genotypes, and(iii) identification of precore/core mutants. The panel consisted of 12 HBV DNA-positive samples with VLs from 2.8 to 9.1 log10copies/ml, different HBV genotypes (A to F), and 3 mutant and 9 wild-type samples at nucleotide 1896. The coefficients of variation of the mean VLs ranged from 2.4% to 10.4% with the Cobas HBV Monitor assay, from 1.8% to 5.5% with the CobasTaqMan 48, from 1.5 to 26.2% with RealArt HBV PCR, and from 0 to 7% with branched DNA (bDNA). The Cobas Monitor assay underestimated the VLs of genotype F samples, with differences ranging from 1.4 to 2.4 log10copies/ml. The accuracies of genotype determinations ranged from 33% to 100%, and those of precore mutant determinations ranged from 25 to 100%. This study showed some drawbacks of two widely used assays: (i) Cobas Monitor has a narrow dynamic range and underestimates genotype F sample VLs and (ii) bDNA shows poor sensitivity and may fail to identify patients with low VLs. With higher performance in terms of analytical sensitivity combined with a larger dynamic range and an ability to quantify the main genotypes equally, real-time PCR methods appear more appropriate for accurate monitoring of HBV DNA quantification. Furthermore, the clinical implications of HBV genotyping and the determination of precore/core mutants need to be clearly stated to justify the standardization of these methods.
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