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Expertise of laboratories in viral load quantification, genotyping, and precore mutant determination for hepatitis B virus in a multicenter study
Authors: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
Affiliation:Centre National de Référence pour les Hépatites B et C en Transfusion, Département des Agents Transmissibles par le Sang, Institut National de la Transfusion Sanguine, Paris, France. slaperche@ints.fr
Abstract:A 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 log(10) copies/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 Cobas TaqMan 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 log(10) copies/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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