标准编号：ISO 20186-1:2019
中文名称：分子体外诊断检查 静脉全血预检查程序规范 第1部分：分离的细胞RNA
英文名称：Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
发布日期：2019-02
标准范围
This document gives guidelines on the handling, storage, processing and documentation of venous
whole blood specimens intended for cellular RNA examination during the pre-examination phase
before a molecular examination is performed. This document covers specimens collected in venous
whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination performed by medical
laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and
manufacturers, biobanks, institutions and commercial organizations performing biomedical research,
and regulatory authorities.
Different dedicated measures are taken for stabilizing blood cell free circulating RNA and RNA in
exosomes circulating in blood. These are not described in this document.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary
blood as well as for collecting and storing blood by paper based technologies or other technologies
generating dried blood. These are not described in this document.
This document does not cover the isolation of specific blood cells and subsequent isolation of cellular
RNA therefrom.
RNA in pathogens present in blood is not covered by this document.
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