本文件给出了在进行分子检测之前的检测前阶段，用于检测从循环肿瘤细胞（CTC）中分离的人类细胞RNA的静脉全血样本的处理、储存、处理和记录的指南。本文件适用于分子体外诊断检查，包括由医学实验室进行的实验室开发的测试。它还打算用于实验室客户、体外诊断开发人员和制造商、生物银行、从事生物医学研究的机构和商业组织以及监管机构。本文件不包括直接从含ctc的静脉全血中分离细胞RNA。这包含在EN ISO 20186-1中。本文件不包括特定血细胞的分离以及随后从中分离细胞RNA。本文件不包括血液中病原体的RNA。注:国际、国家或地区法规或要求也可适用于本文件所涵盖的特定主题。

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human cellular RNA isolated from Circulating Tumor 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. This document does not cover the isolation of cellular RNA directly from venous whole blood containing CTCs. This is covered in EN ISO 20186-1. This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom. RNA in pathogens present in blood is not covered by this document. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.