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Types, Production and Validation of Reference Materials for Viral Genetic Testing
oleh: Eun-Jung Cho, Eun Jin Lee, Younggil Cha, Nuri Lee, Ki Ho Hong, Hee Jin Huh, Young Joo Cha, Hyun Soo Kim
Format: | Article |
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Diterbitkan: | Korean Society of Clinical Microbiology 2020-06-01 |
Deskripsi
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.