Ann Clin Microbiol.  2020 Mar;23(2):. 10.5145/ACM.2020.23.2.2.

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

Affiliations
  • 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 College of Medicine, Goyang, Korea 
  • 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.

Keyword

In vitro diagnostic test; Reference material; Viruses
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