本文件提供了静脉全血和CTC（循环肿瘤细胞）富集、CTC分离和其他分析染色制剂（即。，常规细胞化学和免疫细胞化学染色）在进行细胞病理学评估之前的检查前阶段。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。本文件不包括具体的染色程序。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 and the CTC (Circulating Tumor Cell) enrichment, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical staining) of CTCs during the pre-examination Phase before the cytopathological evaluation 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 specific staining procedures. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.