本文件规定了人力资源的处理、储存、处理和记录指南 在进行分子检查之前的检查前阶段，用于对循环肿瘤细胞（CTC）进行染色的静脉全血样本。 本文件适用于包括实验室在内的分子诊断检查 由医学实验室进行的开发测试。它也可供实验室使用 vitrodiagnostics开发商和制造商、生物银行、机构和商业银行的客户 从事生物医学研究的组织和监管机构。交叉引用:ISO 15189:2012 EN ISO 15189:2012 ISO 15190ISO/IEC 17020: 2012年EN ISO/IEC 17020（ISO/IEC 17020:2012）以及购买本文件时可用的所有现行修订本。

This document specifies guidelines on the handling, storage, processing and documentation of human venous whole blood specimens intended for staining of circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed. This document is applicable to molecularin vitrodiagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers,in vitrodiagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.Cross References:ISO 15189:2012EN ISO 15189:2012ISO 15190ISO/IEC 17020:2012EN ISO/IEC 17020 (ISO/IEC 17020:2012) ASAll current amendments available at time of purchase are included with the purchase of this document.