Format

Send to

Choose Destination
Emerg Infect Dis. 2013 May;19(5):729-35. doi: 10.3201/eid1905.121845.

World Health Organization International Standard to harmonize assays for detection of hepatitis E virus RNA.

Author information

1
Paul-Ehrlich-Institut, Langen, Germany. sally.baylis@pei.de

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.

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

PMID:
23647659
PMCID:
PMC3647515
DOI:
10.3201/eid1905.121845
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for CDC-NCEZID Icon for PubMed Central
Loading ...
Support Center