Performance Evaluation of the New Roche cobas AmpliPrep/cobas TaqMan HCV Test, Version 2.0, for Detection and Quantification of Hepatitis C Virus RNA

被引：31
|
作者：
Pas, S. [1 ]
Molenkamp, R. [2 ]
Schinkel, J. [2 ]
Rebers, S. [2 ]
Copra, C. [1 ]
Seven-Deniz, S. [1 ]
Thamke, D. [3 ]
de Knegt, R. J. [4 ]
Haagmans, B. L. [1 ]
Schutten, M. [1 ]
机构：
[1] Erasmus MC, Dept Virol, Rotterdam, Netherlands
[2] Univ Amsterdam, Acad Med Ctr, Dept Med Microbiol, Clin Virol Lab, NL-1105 AZ Amsterdam, Netherlands
[3] Roche Mol Diagnost, Rotkreuz, Switzerland
[4] Erasmus MC, Dept Gastroenterol & Hepatol, Rotterdam, Netherlands
来源：
JOURNAL OF CLINICAL MICROBIOLOGY | 2013年 / 51卷 / 01期
关键词：
GENOTYPE INCLUSIVITY; QUALITATIVE ASSAY; AMPLIFICATION; SYSTEM;
D O I：
10.1128/JCM.01729-12
中图分类号：
Q93 [微生物学];
学科分类号：
071005 ; 100705 ;
摘要：
To evaluate the analytical performance and explore the clinical applicability of the new Roche cobas AmpliPrep/cobas TaqMan HCV test, v2.0 (CAP/CTM v2.0), a platform comparison was performed on panels and diagnostic samples with the Roche cobas AmpliPrep/cobas TaqMan HCV test (CAP/CTM v1.0), the Siemens Versant HCV RNA 3.0 branched DNA (bDNA) test, the Abbott m2000 RealTime HCV assay (Realtime assay), and the Siemens Versant HCV transcription-mediated amplification (TMA) test (TMA assay). The analytical performance of the CAP/CTM v2.0 on WHO and Acrometrix panels and clinical specimens of patients infected with HCV genotype 1, 2, 3, 4, 5, or 6 relative to that of the CAP/CTM v1.0 was significantly improved. In a qualitative comparison of the CAP/CTM v2.0 relative to the TMA assay on genotype 1 to 4 samples, the two tests proved to be almost equally sensitive. Response-guided therapy in one of five HCV genotype 4-infected patients previously tested with the CAP/CTM v1.0 would have significantly changed if tested with the CAP/CTM v2.0. In conclusion, the Roche CAP/CTM v2.0 has significantly better performance characteristics than the former CAP/CTM HCV v1.0 and the bDNA assay and performance characteristics comparable to those of the Realtime assay.
引用
收藏
页码：238 / 242
页数：5
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