分子体外诊断检查 - 冷冻组织预检过程规范 - 第1部分:分离的RNA

[中文适用范围]： 本文件提供了在进行分子测定之前的预检查阶段用于 RNA 检查的冷冻组织标本的处理、记录、储存和处理的指南。 本文件适用于医学实验室和分子病理学实验室进行的任何评估从冷冻组织中提取的 RNA 的分子体外诊断检查。 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。 本文件不包括冷冻前经过化学稳定预处理的组织。 注：国际、国家或地区法规或要求也适用于本文件中涵盖的特定主题。 [外文原描述]： This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate RNA extracted from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.