标准摘要
[中文适用范围]： 本文件提供了在进行分析测试之前的预检查阶段用于循环游离 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标本。 本文件适用于医学实验室进行的任何分子体外诊断检查。 它还旨在供实验室客户、体外诊断开发商和制造商、生物银行、进行生物医学研究的机构和商业组织以及监管机构使用。 为了稳定血液基因组DNA，采取了不同的专用措施，本文件中没有描述这些措施。 ISO 20186-2 涵盖了血液基因组 DNA。 为了保存循环外泌体中的 DNA，采取了不同的专用措施，本文件中没有描述这些措施。 注：通过本文件中引用的程序从血液中获得的 ccfDNA 可能包含最初存在于外泌体中的 DNA[8][9]。 本文件不涉及血液中病原体的 DNA。 [外文原描述]： 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.
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