分子体外诊断检查.静脉全血预检查程序规范.第1部分:分离细胞RNA

[中文适用范围]： 本文件提供了在进行分子检查之前的预检查阶段用于细胞 RNA 检查的静脉全血样本的处理、储存、加工和记录的指南。 本文件涵盖静脉全血采集管中采集的标本。 本文件适用于医学实验室进行的任何分子体外诊断检查。 它还旨在供实验室客户、体外诊断开发商和制造商、生物银行、进行生物医学研究的机构和商业组织以及监管机构使用。 采取不同的专门措施来稳定血液中循环的无血细胞循环 RNA 和外泌体中的 RNA。 这些在本文档中没有描述。 采取不同的专门措施来收集、稳定、运输和储存毛细血管血，以及通过纸基技术或其他产生干血的技术来收集和储存血液。 这些在本文档中没有描述。 该文件不包括特定血细胞的分离以及随后从中分离细胞RNA。 本文件不涉及血液中病原体的 RNA。 [外文原描述]： 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.