标准摘要
[中文适用范围]： 本文件提供了有关在进行分子测定之前的预检查阶段用于检查分离蛋白质的冷冻组织标本的处理、记录、储存和处理的指南。 本文件适用于由医学实验室和分子病理学实验室进行的评估从冷冻组织中分离的蛋白质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。 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 the examination of isolated proteins 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 proteins isolated 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. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
英文名称Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins