ISO 20166-4:2021 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

标准编号：ISO 20166-4:2021

中文名称：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

英文名称：Molecular in vitro diagnostic examinations — Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniques

发布日期：2021-07

标准范围

本文件规定了福尔马林固定和石蜡包埋（FFPE）组织样本在预检查阶段的收集、处理、记录、运输、储存和处理的要求，并给出了建议，这些样本旨在通过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（如代谢物、蛋白质、DNA和/或RNA）进行定性和/或（半）定量原位检查。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、生物库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组织中分离用于检查的RNA、蛋白质和DNA的预检查阶段。这些都包含在ISO中？20166-1，ISO？20166-2和ISO？20166-3，分子体外诊断检查？-分别用于分离的RNA、蛋白质和DNA的预检查过程的规范。对细针抽吸物（FNA）的预检查过程采取了不同的专用措施。这些都在CEN WI？00140128，岑威？00140126，和CEN WI？00140129，分子体外诊断检查？-细针抽吸物（FNA）分别分离的细胞RNA、分离的蛋白质和分离的基因组DNA的预检查过程规范。笔记？国际、国家或地区法规或要求也适用于本文件涵盖的特定主题。

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.

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