Development and characterization of secondary standards for nucleic acid amplification technology (NAAT) assays for detection of hepatitis E virus.

Autor: Fares-Gusmao R; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Jiang Z; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Subramaniam S; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Visser BJ; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Scott A; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Ishida Y; Department of Medicine, Division of Gastrointestinal and Liver Diseases, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.; Research and Development Department, PhoenixBio, Co., Ltd, Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan., Saito T; Department of Medicine, Division of Gastrointestinal and Liver Diseases, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.; Department of Molecular Microbiology and Immunology, University of Southern California, Keck School of Medicine, Los Angeles, California, USA., Baylis SA; Viral Safety Section, Paul-Ehrlich-Institut, Langen, Germany., McGivern DR; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.. Electronic address: David.McGivern@fda.hhs.gov.
Jazyk: angličtina
Zdroj: Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology [J Clin Virol] 2022 Dec; Vol. 157, pp. 105325. Date of Electronic Publication: 2022 Nov 08.
DOI: 10.1016/j.jcv.2022.105325
Abstrakt: Background: To harmonize assays for detection of HEV RNA, a World Health Organization International Standard (WHO IS) was established. The WHO IS represents the highest order standard for HEV RNA but is limited in quantity. Secondary standards are needed to limit the use of WHO IS and minimize the need to replace it.
Objective: Establish secondary standards for HEV NAAT assays and to calibrate these against the WHO IS.
Methods: Stocks of genotype 3 HEV were prepared using both cell lysates and cell culture supernatants to produce non-enveloped and quasi-enveloped virus stocks, respectively. Both stocks were heat-inactivated, diluted in negative human plasma, and lyophilized to produce two candidate secondary standards: HEV-RR (non-enveloped virus) and HEV-RR.1 (quasi-enveloped virus). Both candidate standards were characterized and calibrated against the WHO IS for HEV RNA in an international collaborative study.
Results: The collaborative study returned a total of 15 data sets, with different RNA extraction and amplification methods. The estimated mean values relative to the WHO IS (250,000 IU/ml) are 229,000 IU/ml and 355,000 IU/ml for HEV-RR and HEV-RR.1, respectively.
Conclusion: We have established two secondary standards for HEV RNA calibrated against the WHO IS. These standards are non-infectious and stable under different storage temperatures.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Published by Elsevier B.V.)
Databáze: MEDLINE
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