本文件规定了在分子检查前的预检查阶段，用于对循环肿瘤细胞（CTC）染色的人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 specifies requirements and gives recommendations on the handling, storage, CTC enrichment, preparation for CTC staining, and documentation of venous whole blood specimens intended for staining of CTCs during the pre-examination phase before an examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests 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. This document does not cover pre-analytical workflow requirements for viable CTC cryopreservation and culturing. Different dedicated measures are taken for stabilizing CTCs genomic DNA and RNA that are not described in this document; they are covered in ISO 7552-1 and ISO 7552-2. NOTE 1        The requirements given in this document can also be applied to other circulating rare cells (e.g. foetal cells). NOTE 2        International, national or regional regulations or requirements can also apply to specific topics covered in this document.