ISO 20186-3:2019 分子体外诊断检查 静脉全血预检程序规范 第3部分：从血浆中分离的循环细胞游离DNA

标准编号：ISO 20186-3:2019

中文名称：分子体外诊断检查 静脉全血预检程序规范 第3部分：从血浆中分离的循环细胞游离DNA

英文名称：Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma

发布日期：2019-09

标准范围

本文件提供了在进行分析测试前的预检查阶段，用于循环无细胞DNA（ccfDNA）检查的静脉全血样本的处理、储存、处理和记录的建议和要求。本文件涵盖静脉全血采集管中采集的样本。本文件适用于医学实验室进行的任何分子体外诊断检查。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。为稳定血液基因组DNA，采取了不同的专用措施，本文件未对此进行描述。血液基因组DNA包含在ISO 20186-2中。为了在循环的外显体中保存DNA，采取了不同的专门措施，本文件未对此进行描述。注:通过本文引用的程序从血液中获得的ccfDNA可能包含最初存在于外显体中的DNA。本文件不包括血液中病原体的DNA。

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. This document covers specimens collected in venous whole blood collection tubes.This document is applicable to any molecular in vitro diagnostic examination performed by medical 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.Different dedicated measures are taken for stabilizing blood genomic DNA, which are not described in this document. Blood genomic DNA is covered in ISO 20186-2.Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in this document.NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally present in exosomes^[8][9].DNA in pathogens present in blood is not covered by this document.

标准预览图