title: World Health Organization International Standard to harmonize assays for detection of hepatitis E virus RNA.
abstract: 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.
authors: Paul-Ehrlich-Institut, Langen, Germany. sally.baylis@pei.de
authors: Sally A
authors: SA
authors: Baylis
authors: Johannes
authors: J
authors: Blümel
authors: Saeko
authors: S
authors: Mizusawa
authors: Keiji
authors: K
authors: Matsubayashi
authors: Hidekatsu
authors: H
authors: Sakata
authors: Yoshiaki
authors: Y
authors: Okada
authors: C Micha
authors: CM
authors: Nübling
authors: Kay-Martin O
authors: KM
authors: Hanschmann
mesh_terms: D001681:Biological Assay / Q000592:standards*; D014943:Global Health; D016751:Hepatitis E / Q000097:blood / Q000175:diagnosis* / Q000821:virology; D016752:Hepatitis E virus / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D007391:International Cooperation; D010802:Phylogeny; D012367:RNA, Viral / Q000097:blood / Q000235:genetics*; D012680:Sensitivity and Specificity; D014944:World Health Organization
chemical_list: D012367:RNA, Viral
keywords: HEV; NAT; RNA; WHO; World Health Organization; assays; detection; genotype; genotype 3; genotype 3a; hepatitis; hepatitis E virus; international standard; nucleic acid amplification technique; standardization; strains; subgenotype; viruses
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