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

Eun-Jung Cho1   Eun Jin Lee1   Younggil Cha23   Nuri Lee1   Ki Ho Hong4   Hee Jin Huh5   Young Joo Cha6   Hyun Soo Kim1*   

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

* Corresponding author: Tel: +82-31-8086-2775, Fax: +82-31-8086-2789, E-mail: hskim0901@empas.com

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.

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