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Volume 10,Issue 1

Fall 2025

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12 October 2023

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

Eun-Jung Cho1 Eun Jin Lee1 Younggil Cha1 Nuri Lee1 Ki Ho Hong1 Hee Jin Huh1 Young Joo Cha1 Hyun Soo Kim1
© 2019 by the Author(s). Licensee Whioce Publishing, USA. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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 the required properties is increasing. In this review, the types, manufacturing methods, and verification of RMs for genetic testing of viruses are discussed along with the producers involved in their production, sale, and distribution.

Keywords
In vitro diagnostic test
Reference material
Viruses
Conflict of interest
The authors declare they have no competing interests.
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