@article{da89b69056d742a5b1a97e1f89801266,
title = "Development and characterization of secondary standards for nucleic acid amplification technology (NAAT) assays for detection of hepatitis E virus",
abstract = "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.",
keywords = "Biological standards, Hepatitis E virus, Molecular testing, Nucleic acid tests, Secondary standards, Standardization",
author = "{The HEV Standard Calibration Study Group} and Rafaelle Fares-Gusmao and Zhen Jiang and Sakthivel Subramaniam and Visser, {Bryan J.} and Alysia Scott and Yuji Ishida and Takeshi Saito and Baylis, {Sally A.} and McGivern, {David R.} and Carla Osiowy and Jamie Borlang and Tyler Kosowan and Roswitha Kleiber and Wenzel, {J{\"u}rgen J.} and Mathias Schemmerer and Jasmin Klein and Giulio Pisani and Matteo Simeoni and Antonio Martina and Hidekatsu Sakata and Juri Iida and Yu Kobayashi and Boris Hogema and {Molenaar-de Backer}, Marijke and Niesters, {Hubert G.} and Lilli Rurenga-Gard and Tonya Hayden and Saleem Kamili and Heather Cox and Nicole Dyer and Priscilla Wu and Jeff Linnen and Jasmine Cooper and Kristin Livezey",
note = "Funding Information: We thank Dr. Suzanne Emerson (NIH) for the gift of HEV ORF2- specific hyperimmune plasma from an HEV-infected chimpanzee (Ch1313). We thank the participation of all collaborating laboratories that have provided results for this study. The project was supported by appointments to the ORISE Research Fellowship Program at CBER administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration. We thank the Facility for Biotechnology Resources (FBR) at CBER/FDA for assistance with nucleotide sequencing and analysis. Funding Information: This work has been funded by CBER/FDA Intramural Funding . HCLM-HH cultures production was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) under award number [ R01DK101773:TS ], by the National Institute of Allergy and Infectious Diseases (NIAID)/NIH under award number [ R21AI139954:TS ] and by a PhoenixBio Research Grant [to TS and YI]. Publisher Copyright: {\textcopyright} 2022",
year = "2022",
month = dec,
doi = "10.1016/j.jcv.2022.105325",
language = "English",
volume = "157",
journal = "Journal of Clinical Virology",
issn = "1386-6532",
publisher = "ELSEVIER SCIENCE BV",
}