Paul-Ehrlich-Institut, Langen, Germany.
Emerg Infect Dis. 2013 May;19(5):729-35. doi: 10.3201/eid1905.121845.
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.
基于核酸扩增技术的检测方法是检测急性戊型肝炎病毒（HEV）感染的主要方法，但检测灵敏度差异很大。为了提高检测和定量 HEV RNA 的实验室间结果，对一种候选世界卫生组织（WHO）国际标准（IS）株在一项涉及来自 10 个国家的 23 个实验室的合作研究中进行了评估。IS 编号为 6329/10，是使用来自献血的基因型 3a HEV 株，在人血浆中稀释并冻干制成的。同时制备和评估了一种日本国家标准，代表基因型 3b HEV 株。通过定性和定量检测确定了标准的效价。当 HEV RNA 浓度相对于 IS 表示时，检测的可变性大大降低。因此，世界卫生组织已将 6329/10 确立为 HEV RNA 的 IS，其单位为每毫升 250,000 国际单位。
