本文件给出了在分子检查前的预检查阶段，用于检查从循环肿瘤细胞（CTC）分离的人类DNA的静脉全血标本的处理、储存、处理和记录指南。 本文件适用于医学实验室、体外诊断开发商和制造商、从事生物医学研究的机构和商业组织进行和/或开发的分子体外诊断检查。 它也旨在供实验室客户使用，包括要求为患者进行检查的卫生机构以及生物库和监管机构。 本文件不涉及直接从含有CTC的静脉全血中分离基因组DNA。这在ISO 20186-2，分子体外诊断检查-静脉全血预检查过程规范中有所涉及- 第二部分:分离的基因组DNA。 本文件不包括特定白细胞的分离以及随后从中分离基因组DNA。 本文件不包括可行CTC冷冻保存和培养的分析前工作流程要求。 注1:本文件中给出的要求也适用于其他循环的稀有细胞（如胎儿细胞）。 注2: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 gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human DNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations performed and/or developed by medical laboratories, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research. It is also intended to be used by laboratory customers including health institutions requesting examinations for their patients as well as biobanks and regulatory authorities. This document does not cover the isolation of genomic DNA directly from venous whole blood containing CTCs. This is covered in ISO 20186-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA. This document does not cover the isolation of specific white blood cells and subsequent isolation of genomic DNA therefrom. This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing. NOTE 1 The requirements given in this document can also be applied to other circulating rare cells (e.g. fetal cells). NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.