ArticleJournal of clinical microbiology2006
Expertise of laboratories in viral load quantification, genotyping, and precore mutant determination for hepatitis B virus in a multicenter study.
Article in Journal of clinical microbiology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update.Hepatology international · 2016Guideline
- A Highly Prevalent Polymorphism in the Core Region Impairs Quantification of Hepatitis B Virus (HBV) by the cobas TaqMan HBV Assay.Journal of clinical microbiology · 2020Article
- Hepatitis B surface antigen: association with sustained response to peginterferon alfa-2a in hepatitis B e antigen-positive patients.Hepatology international · 2013Article
- Correlation between viral load of HBV in chronic hepatitis B patients and precore and Basal core promoter mutations.Hepatitis monthly · 2013Article
- A latest and promising approach for prediction of viral load in hepatitis B virus infected patients.Indian journal of human genetics · 2011Article
- Robust hepatitis B virus genotyping by mass spectrometry.Journal of clinical microbiology · 2010Article
- Nuclease-resistant double-stranded DNA controls or standards for hepatitis B virus nucleic acid amplification assays.Virology journal · 2009Article
- Comparison of clinical application of the Abbott HBV PCR kit and the VERSANT HBV DNA 3.0 test to measure serum hepatitis B virus DNA in Taiwanese patients.The Kaohsiung journal of medical sciences · 2009Article
- Virologic monitoring of hepatitis B virus therapy in clinical trials and practice: recommendations for a standardized approach.Gastroenterology · 2008Review
- Characterization of a new sensitive PCR assay for quantification of viral DNA isolated from patients with hepatitis B virus infections.Journal of clinical microbiology · 2007Article
- Multicenter trials need to use the same assay for hepatitis C virus viral load determination.Journal of clinical microbiology · 2007Article
- Molecular testing in the diagnosis and management of chronic hepatitis B.Clinical microbiology reviews · 2007Review
- Management of chronic hepatitis B: consensus guidelines.Canadian journal of gastroenterology = Journal canadien de gastroenterologie · 2007Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 14 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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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Registered trials
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