分子体外诊断检查 - 福尔马林固定和石蜡包埋（FFPE）组织的前检查方法规范 - 第2部分:分离的蛋白质

[中文适用范围]： 本文件提供了在分子检测前预检阶段用于分离蛋白检测的福尔马林固定石蜡包埋 (FFPE) 组织样本的处理、记录、储存和加工指南。本文件适用于分子体外诊断检测，包括医学实验室和分子病理学实验室开展的实验室自主研发检测。本文件也适用于实验室客户、体外诊断产品开发商和制造商、生物库、从事生物医学研究的机构和商业组织以及监管机构。本文件不适用于免疫组织化学检测。 [外文原描述]： This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) 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 molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology 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. This document is not applicable for protein examination by immunohistochemistry. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.