Development of a World Health Organization International Reference Panel for different genotypes of hepatitis E virus for nucleic acid amplification testing.

Autor: Baylis SA; Paul-Ehrlich-Institut, Langen, Germany. Electronic address: Sally.Baylis@pei.de., Hanschmann KO; Paul-Ehrlich-Institut, Langen, Germany., Matsubayashi K; Central Blood Institute, Japanese Red Cross Society, Tokyo, Japan., Sakata H; Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan., Roque-Afonso AM; Virologie AP-HP Hôpital Paul Brousse, Villejuif, France., Kaiser M; GenExpress Gesellschaft für Proteindesign mbH, Berlin, Germany., Corman VM; Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Virology, Berlin, Germany; German Centre for Infection Research (DZIF), Berlin, Germany., Kamili S; Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, USA., Aggarwal R; Central Blood Institute, Japanese Red Cross Society, Tokyo, Japan; Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India., Trehanpati N; Institute of Liver and Biliary Sciences, New Delhi, India., Gärtner T; Octapharma, Frankfurt am Main, Germany., Thomson EC; University of Glasgow Centre for Virus Research, UK., Davis CA; University of Glasgow Centre for Virus Research, UK., da Silva Filipe A; University of Glasgow Centre for Virus Research, UK., Abdelrahman TT; University of Glasgow Centre for Virus Research, UK; Microbiology Department, King Fahad Medical City, Riyadh, Saudi Arabia., Blümel J; Paul-Ehrlich-Institut, Langen, Germany., Terao E; European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France.
Jazyk: angličtina
Zdroj: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2019 Oct; Vol. 119, pp. 60-67. Date of Electronic Publication: 2019 May 14.
DOI: 10.1016/j.jcv.2019.05.006
Abstrakt: Background: Globally, hepatitis E virus (HEV) is a major cause of acute viral hepatitis. Epidemiology and clinical presentation of hepatitis E vary greatly by location and are affected by the HEV genotype. Nucleic acid amplification technique (NAT)-based assays are important for the detection of acute HEV infection as well for monitoring chronic cases of hepatitis E.
Objectives: The aim of the study was to evaluate a panel of samples containing different genotypes of HEV for use in nucleic NAT-based assays.
Study Design: The panel of samples comprises eleven different members including HEV genotype 1a (2 strains), 1e, 2a, 3b, 3c, 3e, 3f, 4c, 4g as well as a human isolate related to rabbit HEV. Each laboratory assayed the panel members directly against the 1 st World Health Organization (WHO) International Standard (IS) for HEV RNA (6329/10) which is based upon a genotype 3 a strain.
Results: The samples for evaluation were distributed to 24 laboratories from 14 different countries and assayed on three separate days. Of these, 23 participating laboratories returned a total of 32 sets of data; 17 from quantitative assays and 15 from qualitative assays. The assays used consisted of a mixture of in-house developed and commercially available assays. The results showed that all samples were detected consistently by the majority of participants, although in some cases, some samples were detected less efficiently.
Conclusions: Based on the results of the collaborative study the panel (code number 8578/13) was established as the "1st International Reference Panel (IRP) for all HEV genotypes for NAT-based assays" by the WHO Expert Committee on Biological Standardization. This IRP will be important for assay validation and ensuring adequate detection of different genotypes and clinically important sub-genotypes of HEV.
(Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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