本文件给出了处理、储存、处理和记录人力资源的指南 用于检测从循环肿瘤中分离的RNA的静脉全血样本 细胞（CTC）在进行分子检测前的预检测阶段。 本文件适用于分子体外诊断检查，包括实验室检查 由医学实验室进行的开发测试。它也可供实验室使用 客户、体外诊断开发商和制造商、生物银行、机构和商业机构 从事生物医学研究的组织和监管机构。 交叉引用:EN ISO 15189:2012ISO 15189:2012EN ISO/IEC 17020（ISO/IEC 17020:2012）ASISO/IEC 17020:2012CEN/TS 17390-3购买本文件时提供的所有现行修订版均包含在购买本文件中。

This document gives guidelines on the handling, storage, processing and documentation of human venous whole blood specimens intended for the examination of RNA 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 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.Cross References:EN ISO 15189:2012ISO 15189:2012EN ISO/IEC 17020 (ISO/IEC 17020:2012) ASISO/IEC 17020:2012CEN/TS 17390-3All current amendments available at time of purchase are included with the purchase of this document.