Expertise of Laboratories in Viral Load Quantification, Genotyping, and Precore Mutant Determination for Hepatitis B Virus in a Multicenter Study

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 w...

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Bibliographic Details
Published in:Journal of Clinical Microbiology 2006-10, Vol.44 (10), p.3600-3607
Main 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
Format: Article
Language:English
Subjects:
Bacteriology
Biological and medical sciences
France
Fundamental and applied biological sciences. Psychology
Genotype
Hepatitis B
Hepatitis B - virology
Hepatitis B virus
Hepatitis B virus - genetics
Hepatitis B virus - isolation & purification
Human health and pathology
Humans
Infectious diseases
Laboratories
Laboratories - standards
Life Sciences
Medical sciences
Microbiology
Microbiology and Parasitology
Miscellaneous
Multicenter Studies as Topic
Multicenter Studies as Topic - standards
Mutation
Viral Core Proteins
Viral Core Proteins - genetics
Viral Load
Virology
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Summary: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 log10 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 log10 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.
ISSN:0095-1137
1098-660X
1098-5530
DOI:10.1128/jcm.00732-06