Baylis, Sally A. and Hanschmann, Kay-Martin O. and Matsubayashi, Keiji and Sakata, Hidekatsu and Roque-Afonso, Anne-Marie and Kaiser, Marco and Corman, Victor M. and Kamili, Saleem and Aggarwal, Rakesh and Trehanpati, Nirupma and Gaertner, Thomas and Thomson, Emma C. and Davis, Christopher A. and Filipe, Ana da Silva and Abdelrahman, Tamer T. and Bluemel, Johannes and Terao, Eriko and Pullirsch, Dieter and Hottowy, Brigitte and Lewis-Ximenez, Lia Laura and Pinto, Marcelo Alves and Wang, Youchun and Huang, Weijin and Zhao, Chenyan and Zheng, Zizheng and Shih, James Wai Kuo and Tang, Zi-Min and Ji, Wen-Fang and Izopet, Jacques and Lhomme, Sebastien and Dubois, Martine and Schoenborn, Maike and Beckort, Christiane and Hess, Markus and Tillack, Manuela and Brischke, Daniel and Vollmer, Tanja and Dreier, Jens and Wenzel, Juergen and Klein, Jasmin and O'Riordan, Joan and Murphy, Jessica and Boland, Fiona and Pacini, Barbara and Pisani, Giulio and Simeoni, Matteo and Fabi, Sara and Mizusawa, Saeko and Uchida, Shigeharu and Ekvarn, Elisabet and Hogema, Boris and Schuurman, Tim and Schaer, Oliver and Ijaz, Samreen and Dicks, Steven and Haywood, Becky and Mixson-Hayden, Tonya and Linnen, Jeffrey and Ong, Edgar and Cory, Robin (2019) Development of a World Health Organization International Reference Panel for different genotypes of hepatitis E virus for nucleic acid amplification testing. JOURNAL OF CLINICAL VIROLOGY, 119. pp. 60-67. ISSN 1386-6532, 1873-5967
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | RT-PCR; BLOOD; HEV; Hepatitis E virus; HEV; NAT; NAAT; Standardization; Genotype; World Health Organization |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 27 Mar 2020 06:49 |
| Last Modified: | 27 Mar 2020 06:49 |
| URI: | https://pred.uni-regensburg.de/id/eprint/26187 |
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