Annals of Clinical Microbiology, The official Journal of the Korean Society of Clinical Microbiology

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Indexed in KCI, KoreaMed, Synapse, DOAJ
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pISSN 2288-0585 eISSN 2288-6850

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

Original article

Annals of Clinical Microbiology (Ann Clin Microbiol) 2020 March, Volume 23, Issue 2, pages 57-66.

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, 2Molecular Diagnostic Division, Bioneer Corp., Seoul, 3College of Pharmacy, Kangwon National University, Chuncheon, 4Department of Laboratory Medicine, Seoul Medical Center, Seoul, 5Department of Laboratory Medicine, Dongguk University College of Medicine, Goyang, 6Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea

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