World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNA
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)...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Centers for Disease Control and Prevention
2013-05-01
|
| Series: | Emerging Infectious Diseases |
| Subjects: | |
| Online Access: | https://wwwnc.cdc.gov/eid/article/19/5/12-1845_article |
| _version_ | 1818513919020367872 |
|---|---|
| author | Sally A. Baylis Johannes Blümel Saeko Mizusawa Keiji Matsubayashi Hidekatsu Sakata Yoshiaki Okada C. Micha Nübling Kay-Martin O. Hanschmann |
| author_facet | Sally A. Baylis Johannes Blümel Saeko Mizusawa Keiji Matsubayashi Hidekatsu Sakata Yoshiaki Okada C. Micha Nübling Kay-Martin O. Hanschmann |
| author_sort | Sally A. Baylis |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-11T00:08:12Z |
| format | Article |
| id | doaj.art-ddf71a700c4a400f97754f27727997e8 |
| institution | Directory Open Access Journal |
| issn | 1080-6040 1080-6059 |
| language | English |
| last_indexed | 2024-12-11T00:08:12Z |
| publishDate | 2013-05-01 |
| publisher | Centers for Disease Control and Prevention |
| record_format | Article |
| series | Emerging Infectious Diseases |
| spelling | doaj.art-ddf71a700c4a400f97754f27727997e82022-12-22T01:28:15ZengCenters for Disease Control and PreventionEmerging Infectious Diseases1080-60401080-60592013-05-0119572973510.3201/eid1905.121845World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNASally A. BaylisJohannes BlümelSaeko MizusawaKeiji MatsubayashiHidekatsu SakataYoshiaki OkadaC. Micha NüblingKay-Martin O. HanschmannNucleic 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.https://wwwnc.cdc.gov/eid/article/19/5/12-1845_articlehepatitis E virusHEVNATstandardizationRNAhepatitis |
| spellingShingle | Sally A. Baylis Johannes Blümel Saeko Mizusawa Keiji Matsubayashi Hidekatsu Sakata Yoshiaki Okada C. Micha Nübling Kay-Martin O. Hanschmann World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNA Emerging Infectious Diseases hepatitis E virus HEV NAT standardization RNA hepatitis |
| title | World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNA |
| title_full | World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNA |
| title_fullStr | World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNA |
| title_full_unstemmed | World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNA |
| title_short | World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNA |
| title_sort | world health organization international standard to harmonize assays for detection of hepatitis e virus rna |
| topic | hepatitis E virus HEV NAT standardization RNA hepatitis |
| url | https://wwwnc.cdc.gov/eid/article/19/5/12-1845_article |
| work_keys_str_mv | AT sallyabaylis worldhealthorganizationinternationalstandardtoharmonizeassaysfordetectionofhepatitisevirusrna AT johannesblumel worldhealthorganizationinternationalstandardtoharmonizeassaysfordetectionofhepatitisevirusrna AT saekomizusawa worldhealthorganizationinternationalstandardtoharmonizeassaysfordetectionofhepatitisevirusrna AT keijimatsubayashi worldhealthorganizationinternationalstandardtoharmonizeassaysfordetectionofhepatitisevirusrna AT hidekatsusakata worldhealthorganizationinternationalstandardtoharmonizeassaysfordetectionofhepatitisevirusrna AT yoshiakiokada worldhealthorganizationinternationalstandardtoharmonizeassaysfordetectionofhepatitisevirusrna AT cmichanubling worldhealthorganizationinternationalstandardtoharmonizeassaysfordetectionofhepatitisevirusrna AT kaymartinohanschmann worldhealthorganizationinternationalstandardtoharmonizeassaysfordetectionofhepatitisevirusrna |