Abstract:
BACKGROUND:With the advent of the protease inhibitors boceprevir and telaprevir a novel therapy approach for HCV genotype 1 infected subjects has become standard of care. Quantification of HCV viral load (VL) represents an important predictor of treatment response. METHODS:Two different real-time PCR platforms, the COBAS Ampliprep/COBAS TaqMan v2.0 (CAP-CTM v2.0) and the Abbott RealTime (ART) HCV assay are most widely used. We performed a comparative evaluation of both systems focusing on genotype 1 HCV quantification using clinical specimens, the fourth WHO International Standard for HCV and the Paul Ehrlich National Standard, respectively. RESULTS:The HCV VL assays showed an excellent overall agreement in the clinical specimens studied (R(2)=0.912). Discrepant results were obtained at the low VL end. Four samples tested negative with CAP-CTM v2.0 but were detectable with ART and two samples were undetectable with ART but tested positive with CAP-CTM v2.0. The coefficient of variation in replicate measurements of both reference materials was higher for CAP-CTM v2.0 as compared with ART at the clinical decision point for boceprevir (≥100 IU/ml), but was similar for the two assays at the clinical decision point for telaprevir (≥1,000 IU/ml). The tendency for underestimation of the diluted standards was higher for ART than for CAP-CTM v2.0. CONCLUSIONS:Although both assays allowed accurate determination of VL levels in clinical samples, careful interpretation of results at the low VL end is essential. Furthermore, discontinuation of therapy based on single HCV RNA measurement should be carefully reconciled, unless the issue of assay variability has been addressed adequately.
journal_name
Antivir Therjournal_title
Antiviral therapyauthors
Taylor N,Haschke-Becher E,Greil R,Strasser M,Oberkofler Hdoi
10.3851/IMP2723subject
Has Abstractpub_date
2014-01-01 00:00:00pages
449-54issue
5eissn
1359-6535issn
2040-2058journal_volume
19pub_type
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journal_title:Antiviral therapy
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doi:10.3851/IMP1468
更新日期:2009-01-01 00:00:00
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journal_title:Antiviral therapy
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doi:
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journal_title:Antiviral therapy
pub_type: 杂志文章,评审
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pub_type: 评论,杂志文章
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journal_title:Antiviral therapy
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journal_title:Antiviral therapy
pub_type: 杂志文章,多中心研究
doi:
更新日期:2005-01-01 00:00:00
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journal_title:Antiviral therapy
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更新日期:2008-01-01 00:00:00
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journal_title:Antiviral therapy
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更新日期:2009-01-01 00:00:00
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journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP1717
更新日期:2011-01-01 00:00:00
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journal_title:Antiviral therapy
pub_type: 杂志文章,评审
doi:
更新日期:2001-01-01 00:00:00
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journal_title:Antiviral therapy
pub_type: 杂志文章
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更新日期:2012-01-01 00:00:00
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journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP1940
更新日期:2012-01-01 00:00:00
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更新日期:2011-01-01 00:00:00
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journal_title:Antiviral therapy
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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更新日期:2018-01-01 00:00:00
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journal_title:Antiviral therapy
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更新日期:2017-01-01 00:00:00
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doi:
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pub_type: 杂志文章
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更新日期:2011-01-01 00:00:00
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journal_title:Antiviral therapy
pub_type: 临床试验,杂志文章
doi:
更新日期:1996-04-01 00:00:00
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pub_type: 杂志文章,随机对照试验
doi:
更新日期:2006-01-01 00:00:00
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pub_type: 杂志文章,多中心研究
doi:
更新日期:2009-01-01 00:00:00
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journal_title:Antiviral therapy
pub_type: 杂志文章,评审
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journal_title:Antiviral therapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:2003-08-01 00:00:00
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pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:2003-06-01 00:00:00