Sally A Baylis1, Kay-Martin O Hanschmann2, Keiji Matsubayashi3, Hidekatsu Sakata4, Anne-Marie Roque-Afonso5, Marco Kaiser6, Victor M Corman7, Saleem Kamili8, Rakesh Aggarwal9, Nirupma Trehanpati10, Thomas Gärtner11, Emma C Thomson12, Christopher A Davis12, Ana da Silva Filipe12, Tamer T Abdelrahman13, Johannes Blümel2, Eriko Terao14. 1. Paul-Ehrlich-Institut, Langen, Germany. Electronic address: Sally.Baylis@pei.de. 2. Paul-Ehrlich-Institut, Langen, Germany. 3. Central Blood Institute, Japanese Red Cross Society, Tokyo, Japan. 4. Japanese Red Cross Hokkaido Block Blood Center, Sapporo, Japan. 5. Virologie AP-HP Hôpital Paul Brousse, Villejuif, France. 6. GenExpress Gesellschaft für Proteindesign mbH, Berlin, Germany. 7. 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. 8. Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, USA. 9. Central Blood Institute, Japanese Red Cross Society, Tokyo, Japan; Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. 10. Institute of Liver and Biliary Sciences, New Delhi, India. 11. Octapharma, Frankfurt am Main, Germany. 12. University of Glasgow Centre for Virus Research, UK. 13. University of Glasgow Centre for Virus Research, UK; Microbiology Department, King Fahad Medical City, Riyadh, Saudi Arabia. 14. European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France.
Abstract
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 1st 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.
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 rabbitHEV. Each laboratory assayed the panel members directly against the 1st 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.
Authors: Mario Frías; Pedro López-López; Ismael Zafra; Javier Caballero-Gómez; Isabel Machuca; Ángela Camacho; María A Risalde; Antonio Rivero-Juárez; Antonio Rivero Journal: J Clin Microbiol Date: 2021-01-21 Impact factor: 5.948