World Health Organization International Standard to harmonize assays for detection of hepatitis E virus RNA.
World Health Organization International Standard to harmonize assays for detection of hepatitis E virus RNA.
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DOI：
10.3201/eid1905.121845
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发表时间：
2013-05
影响因子：
11.8
通讯作者：
HEV Collaborative Study Group
中科院分区：
文献类型：
--
作者：
Baylis SA;Blümel J;Mizusawa S;Matsubayashi K;Sakata H;Okada Y;Nübling CM;Hanschmann KM;HEV Collaborative Study Group
基于核酸扩增技术的检测是检测急性戊型肝炎病毒（HEV）感染的主要方法，但检测灵敏度可能差异很大。为了提高HEV RNA检测和定量的实验室间结果，在一项涉及来自10个国家的23个实验室的合作研究中评价了一种候选世界卫生组织（WHO）国际标准（IS）菌株。IS（代码编号6329/10）是使用来自献血的基因型3a HEV毒株配制的，在合并人血浆中稀释并冻干。制备了代表基因型3b HEV毒株的日本国家标准品，并进行了平行评价。通过定性和定量试验测定标准品的效价。当相对于IS表示HEV RNA浓度时，检测变异性显著降低。因此，WHO已将6329/10确定为HEV RNA的IS，单位为每毫升250，000国际单位。
Nucleic acid amplification technique–based assays are a primary method for the detection of acute hepatitis E virus (HEV) infection, but assay sensitivity can vary widely. To improve interlaboratory results for the detection and quantification of HEV RNA, a candidate World Health Organization (WHO) International Standard (IS) strain was evaluated in a collaborative study involving 23 laboratories from 10 countries. The IS, code number 6329/10, was formulated by using a genotype 3a HEV strain from a blood donation, diluted in pooled human plasma and lyophilized. A Japanese national standard, representing a genotype 3b HEV strain, was prepared and evaluated in parallel. The potencies of the standards were determined by qualitative and quantitative assays. Assay variability was substantially reduced when HEV RNA concentrations were expressed relative to the IS. Thus, WHO has established 6329/10 as the IS for HEV RNA, with a unitage of 250,000 International Units per milliliter.
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影响因子：
8.8
作者：
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通讯作者：
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