本文件给出了福尔马林固定和石蜡包埋（FFPE）组织样本的处理、记录、储存和处理指南，用于在进行分子分析之前的预检查阶段检查分离的蛋白质。 本文件适用于分子体外诊断检查，包括由医学实验室和分子病理学实验室进行的实验室开发测试。它也适用于实验室客户、体外诊断开发商和制造商、生物银行、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的蛋白质检查。 注:国际、国家或地区法规或要求也可适用于本文件涵盖的特定主题。

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.