Japanese Reference Panel of Blood Specimens for Evaluation of Hepatitis C Virus RNA and Core Antigen Quantitative Assays
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- Asako Murayama
- Department of Virology II, National Institute of Infectious Diseases, Tokyo, Japan
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- Nao Sugiyama
- Department of Virology II, National Institute of Infectious Diseases, Tokyo, Japan
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- Koichi Watashi
- Department of Virology II, National Institute of Infectious Diseases, Tokyo, Japan
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- Takahiro Masaki
- Department of Virology II, National Institute of Infectious Diseases, Tokyo, Japan
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- Ryosuke Suzuki
- Department of Virology II, National Institute of Infectious Diseases, Tokyo, Japan
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- Hideki Aizaki
- Department of Virology II, National Institute of Infectious Diseases, Tokyo, Japan
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- Toshiaki Mizuochi
- Department of Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo, Japan
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- Takaji Wakita
- Department of Virology II, National Institute of Infectious Diseases, Tokyo, Japan
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- Takanobu Kato
- Department of Virology II, National Institute of Infectious Diseases, Tokyo, Japan
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説明
<jats:title>ABSTRACT</jats:title> <jats:p>An accurate and reliable quantitative assay for hepatitis C virus (HCV) is essential for measuring viral propagation and the efficacy of antiviral therapy. There is a growing need for domestic reference panels for evaluation of clinical assay kits because the performance of these kits may vary with region-specific genotypes or polymorphisms. In this study, we established a reference panel by selecting 80 donated blood specimens in Japan that tested positive for HCV. Using this panel, we quantified HCV viral loads using two HCV RNA kits and five core antigen (Ag) kits currently available in Japan. The data from the two HCV RNA assay kits showed excellent correlation. All RNA titers were distributed evenly across a range from 3 to 7 log IU/ml. Although the data from the five core Ag kits also correlated with RNA titers, the sensitivities of individual kits were not sufficient to quantify viral load in all samples. As calculated by the correlation with RNA titers, the theoretical lower limits of detection by these core Ag assays were higher than those for the detection of RNA. Moreover, in several samples in our panel, core Ag levels were underestimated compared to RNA titers. Sequence analysis in the HCV core region suggested that polymorphisms at amino acids 47 to 49 of the core Ag were responsible for this underestimation. The panel established in this study will be useful for estimating the quality of currently available and upcoming HCV assay kits; such quality control is essential for clinical usage of these kits.</jats:p>
収録刊行物
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- Journal of Clinical Microbiology
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Journal of Clinical Microbiology 50 (6), 1943-1949, 2012-06
American Society for Microbiology