分子体外诊断检查福尔马林固定和石蜡包埋（FFPE）组织的预检查过程规范第4部分:原位检测技术

[中文适用范围]： 本文件规定了用于定性和/或（半）定量的福尔马林固定石蜡包埋（FFPE）组织标本预检查阶段的收集、处理、记录、运输、储存和加工的要求并给出了建议使用不同的原位检测技术对 FFPE 组织切片上的形态和生物分子（例如代谢物、蛋白质、DNA 和/或 RNA）进行原位检查。 本文件适用于使用原位检测技术的体外诊断检查。 这些包括由病理学实验室（组织病理学实验室）以及分子病理学实验室和其他医学实验室进行的实验室开发的测试。 它还旨在供实验室客户、体外诊断开发商和制造商、生物银行以及进行生物医学研究的机构和商业组织以及监管机构使用。 本文件不适用于从FFPE组织中分离的RNA、蛋白质和DNA进行检查的预检查阶段。 这些内容分别包含在 ISO 20166-1、ISO 20166-2 和 ISO 20166-3“分子体外诊断检查 — 分离 RNA、蛋白质和 DNA 预检查过程规范”中。 针对细针抽吸物 (FNA) 的预检查过程采取了不同的专用措施。 这些内容分别在 CEN WI 00140128、CEN WI 00140126 和 CEN WI 00140129 分子体外诊断检查 — 细针抽吸 (FNA) 分离的细胞 RNA、分离的蛋白质和分离的基因组 DNA 的预检查过程规范中进行了介绍。 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 specifies requirements and gives recommendations for the collection, handling, documentation, transport, storage and processing during the pre-examination phase of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for qualitative and/or (semi-)quantitative in situ examination of the morphology and of biomolecules, such as metabolites, proteins, DNA and/or RNA, on FFPE tissue sections by using different in situ detection techniques. This document is applicable to in vitro diagnostic examinations using in situ detection techniques. These include laboratory developed tests performed by pathology laboratories (histopathology laboratories) as well as by molecular pathology laboratories and other medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, as well as institutions and commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable to the pre-examination phase of RNA, proteins and DNA isolated from FFPE tissue for examination. These are covered in ISO 20166-1, ISO 20166-2 and ISO 20166-3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for isolated RNA, proteins and DNA, respectively. Different dedicated measures are taken for pre-examination processes for fine needle aspirates (FNAs). These are covered in CEN WI 00140128, CEN WI 00140126, and CEN WI 00140129, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) isolated cellular RNA, isolated proteins, and isolated genomic DNA, respectively. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.