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Cho, Lee, Cha, Lee, Hong, Huh, Cha, and Kim: Types, Production and Validation of Reference Materials for Viral Genetic Testing
Review Article

Ann Clin Microbiol 2020;23(2):57-66.

Published online: 30 June 2020

DOI: https://doi.org/10.5145/ACM.2020.23.2.2

Types, Production and Validation of Reference Materials for Viral Genetic Testing

Eun-Jung Cho1, Eun Jin Lee1, Younggil Cha2, 3, Nuri Lee1, Ki Ho Hong4, Hee Jin Huh5, Young Joo Cha6, Hyun Soo Kim1

1Department of Laboratory Medicine, Hallym University College of Medicine, Chuncheon, Korea

2Molecular Diagnostic Division, Bioneer Corp., Seoul, Korea

3College of Pharmacy, Kangwon National University, Chuncheon, Korea

4Department of Laboratory Medicine, Seoul Medical Center, Seoul Korea

5Department of Laboratory Medicine, Dongguk University Ilsan Hospital, Ilsan, Korea

6Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea

Corresponding author: Hyun Soo Kim E-mail: hskim0901@empas.com

Received 1 November 2019       Revised 24 December 2019       Accepted 24 December 2019

© Korean Society of Clinical Microbiology. All rights reserved.

This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/.

Abstract

Molecular diagnostic techniques are used for the diagnosis and monitoring of viral infections. The performance of the in vitro diagnostic assays is important for an accurate and prompt diagnosis. Positive clinical samples or reference materials (RMs) are essential for the development, validation, and verification of the assays for molecular diagnostics-based virus detection. Since it is difficult to obtain positive clinical samples, the need for RMs with required properties is increasing. In this review, the types, manufacturing methods, and verification of RMs for genetic testing of virus are discussed along with the producers involved in their production, sale, and distribution.

Keywords: In vitro diagnostic test, Reference material, Viruses

CONFLICTS OF INTEREST

No potential conflicts of interest relevant to this article were reported.

FUNDING

본 연구는 2019년도 식품의약품안전처의 연구개발비(19173MFDS334)로 수행되었으며 이에 감사드립니다.

REFERENCES

1. National Institute for Biological Standards and Control (NIBSC). NIBSC web site on biological reference materials. https://www.nibsc.org/products.aspx/ [Online] (last visited on 30 November 2019).
2. ATCC. ATCC web site on biological reference materials. https://www.atcc.org/ [Online] (last visited on 30 October 2019).
3. NCBI. NCBI web site on Virus. https://www.ncbi.nlm.nih.gov/genome/viruses/ [Online] (last visited on 3 November 2019).
4. Clinical Laboratory and Standards Institute (CLSI). Validation and verification of qualitative multiplex nucleic acid assays, approved guideline. CLSI document MM17. Wayne; PA: 2008.
5. Fryer JF, Heath AB, Minor PD. A collaborative study to establish the 1st WHO international standard for human cytomegalovirus for nucleic acid amplification technology. Biologicals 2016;44:242-51.
6. Fryer JF, Heath AB, Wilkinson DE, Minor PD. A collaborative study to establish the 1st WHO international standard for Epstein-Barr virus for nucleic acid amplification techniques. Biologicals 2016;44:423-33.
7. Paul-Ehrlich-Institut. Paul-Ehrlich-Institut web site on medicinal products. https://www.pei.de/ EN/home/home-node.html/ [Online] (last visited on 20 May 2020).
8. Thompson M, Bonavia A, Ehrhardt R. Virus cryopreservation protocol. Protoc Exch 2012. doi:10.1038/protex.2012.004.
9. Baylis SA, Blumel J, Mizusawa S, Matsubayashi K, Sakata H, Okada Y, et al. World health organization international standard to harmonize assays for detection of hepatitis E virus RNA. Emerg Infect Dis 2013;19:729-35.
10. Khorana HG. Total synthesis of a gene. Science 1979;203:614-25.
11. Lanciotti RS and Kerst AJ. Nucleic acid sequence-based amplification assays for rapid detection of West Nile and St. Louis encephalitis viruses. J Clin Microbiol 2001;39:4506-13.
12. Cazenave C and Uhlenbeck OC. RNA template-directed RNA synthesis by T7 RNA polymerase. Proc Natl Acad Sci U S A 1994;91:6972-6.
13. Kox LF, Rhienthong D, Miranda AM, Udomsantisuk N, Ellis K, van Leeuwen J, et al. A more reliable PCR for detection of Mycobacterium tuberculosis in clinical samples. J Clin Microbiol 1994;32:672-8.
14. Roy S and Caruthers M. Synthesis of DNA/RNA and their analogs via phosphoramidite and H-phosphonate chemistries. Molecules 2013;18:14268-84.
15. Botstein D, Falco SC, Stewart SE, Brennan M, Scherer S, Stinchcomb DT, et al. Sterile host yeasts (SHY): a eukaryotic system of biological containment for recombinant DNA experiments. Gene 1979;8:17-24. .
16. Prodromou C and Pearl LH. Recursive PCR: a novel technique for total gene synthesis. Protein Eng 1992;5:827-9.
17. Van Heuverswyn F, Karczmarczyk M, Schimmel H, Trapmann S, Emons H. Influence of primer & probe chemistry and amplification target on reverse transcription digital PCR quantification of viral RNA. Biomol Detect Quantif 2016;9:20-8.
18. Lodish H, Berk A, Zipursky SL, et al. Section 6.3, Viruses: Structure, Function, and Uses. Molecular Cell Biology. 4th ed. https://www.ncbi.nlm.nih.gov/books/NBK21523/ [Online] (last visited on 15 Oct 2019).
19. National Institute of Standard and Technology (NIST). NIST web site on Standard Reference Materials. https://www.nist.gov/ [Online] (last visited on 3 November 2019).
20. Mattiuzzo G, Ashall J, Doris KS, MacLellan-Gibson K, Nicolson C, Wilkinson DE, et al. Development of lentivirus-based reference materials for ebola virus nucleic acid amplification technology-based assays. PLoS One 2015;10:e0142751. .
21. Zhang L, Sun Y, Chang L, Jia T, Wang G, Zhang R, et al. A novel method to produce armored double-stranded DNA by encapsulation of MS2 viral capsids. Appl Microbiol Biotechnol 2015;99:7047-57.
22. Zeltins A. Construction and characterization of virus-like particles: a review. Mol Biotechnol 2013;53:92-107.
23. Mohsen MO, Gomes AC, Vogel M, Bachmann MF. Interaction of viral capsid-derived viruslike particles (VLPs) with the innate immune system. Vaccines 2018;6:37.
24. Sun Y, Jia T, Sun Y, Han Y, Wang L, Zhang R, et al. External quality assessment for avian influenza A (H7N9) virus detection using armored RNA. J Clin Microbiol 2013;51:4055-9.
25. Davis C, Berry N, Heath A, Holmes H. An international collaborative study to establish a replacement World Health Organization international standard for human immunodeficiency virus 1 RNA nucleic acid assays. Vox Sang 2008;95:218-25.
26. Abdelwahed W, Degobert G, Stainmesse S, Fessi H. Freeze-drying of nanoparticles: formulation, process and storage considerations. Adv Drug Deliv Rev 2006;58:1688-713.
27. WHO. WHO web site on WHO expert commiittee on biological standardization (ECBS). http://www.who.int/biologicals/WHO_ECBS/en/ [Online] (last visited on 3 November 2019).
28. International Organisation for Standardization. ISO Guide 35. Reference materials - guidance for characterization and assessment of homogeneity and stability. 2017.
29. Ministry of Food and Drug Safety (MFDS). MFDS web site on national institute of food and drug safety evaluation. http://www.nifds.go.kr/brd/m_96/list.do./ [Online] (last visited on 30 November 2019).
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