바이러스 유전자 검사 표준물질의 종류, 제조 및 검증
Types, Production and Validation of Reference Materials for Viral Genetic Testing
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초록
바이러스 검사를 위한 분자 진단 기법이 바이러스 감염의 진단 및 모니터링에 사용되는 검사로바이러스 감염의 정확하고 신속한 진단에 바이러스 체외 진단 제품의 성능이 중요하다. 바이러스 양성 임상검체 또는 표준물질은 분자 진단 기반의 바이러스 검출 검사법의 개발 및 검증에 필수적으로 요구된다. 바이러스 양성인 임상 검체를 구하기가 어려우므로 참값이 검증된 표준물질에 대한 필요성이 높아지고 있다. 본 논문에서는 바이러스 유전자 검사의 표준물질의 종류, 제조및 검증방법과 표준물질의 제조, 판매 및 분양처에 대하여 고찰하였다.
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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