Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
5
pubmed:dateCreated
2008-5-7
pubmed:abstractText
Hepatitis B virus (HBV) DNA quantification is used to establish the prognosis of chronic HBV-related liver disease, to identify those patients who need to be treated, and to monitor the virologic response and resistance to antiviral therapies. Real-time PCR-based assays are gradually replacing other technologies for routine quantification of HBV DNA in clinical practice. The goal of this study was to evaluate the intrinsic characteristics and clinical performance of the real-time PCR Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) platform for HBV DNA quantification. Specificity was satisfactory (95% confidence interval, 98.1 to 100%). Intra-assay coefficients of variation ranged from 0.22% to 2.68%, and interassay coefficients of variation ranged from 1.31% to 4.13%. Quantification was linear over the full dynamic range of quantification of the assay (1.7 to 8.0 log(10) IU/ml) and was not affected by dilution. The assay was accurate regardless of the HBV genotype. Samples containing HBV DNA levels above 4.5 log(10) IU/ml were slightly underestimated relative to another accurate assay based on branched-DNA technology, but this is unlikely to have noteworthy clinical implications. Thus, the CAP/CTM HBV DNA assay is sensitive, specific, and reproducible, and it accurately quantifies HBV DNA levels in patients chronically infected by HBV genotypes A to F. Samples with HBV DNA concentrations above the upper limit of quantification need to be diluted and then retested. Broad use of fully automated real-time PCR assays should improve the management of patients with chronic HBV infection.
pubmed:commentsCorrections
http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-10449472, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-10640543, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-10716334, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-11339072, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-11703579, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-12016423, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-14708675, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-14766820, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-14766856, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-15464248, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-16461000, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-16597867, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-17182753, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-17229858, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-17525931, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-9857350, http://linkedlifedata.com/resource/pubmed/commentcorrection/18287319-9862871
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
1098-660X
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
46
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1716-23
pubmed:dateRevised
2009-11-18
pubmed:meshHeading
pubmed:year
2008
pubmed:articleTitle
Performance of the Cobas AmpliPrep/Cobas TaqMan real-time PCR assay for hepatitis B virus DNA quantification.
pubmed:affiliation
French National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris 12.
pubmed:publicationType
Journal Article, Comparative Study, Research Support, Non-U.S. Gov't, Evaluation Studies