本文件规定了静脉全血样本中循环无细胞RNA（ccfRNA）检查前阶段的要求和建议，包括但不限于用于ccfRNA检查的静脉全血样本的收集、处理、储存、处理和记录。本文件涵盖在静脉全血采集管中采集的样本。本文中描述的预检查过程导致从血浆中分离出循环的无细胞RNA，而无需事先富集外泌体和其他细胞外小泡。 本文件适用于医学实验室进行的分子体外诊断检查。它还可供实验室客户、体外诊断开发商和制造商、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使用。在预检查阶段，需要采取不同的专门措施，从富集的外泌体和从静脉全血富集的其他细胞外囊泡中分离出RNA，并从静脉全血中分离出细胞RNA。 这些未在本文件中描述，但包含在CEN/TS 17747,1分子体外诊断检查-静脉全血中外小体和其他细胞外小泡的预检查过程规范-分离的DNA、RNA和蛋白质中，以及EN ISO 20186-1，分子体外诊断检查.静脉全血预检查过程规范.第1部分:分离细胞RNA。注:国际、国家或地区法规或要求也可适用于本文件涵盖的特定主题。

This document specifies requirements and recommendations for the pre-examination phase of circulating cell free RNA (ccfRNA) from venous whole blood specimens, including but not limited to the collection, handling, storage, processing and documentation of venous whole blood specimens intended for ccfRNA examination. This document covers specimens collected in venous whole blood collection tubes.The pre-examination process described in this document results in circulating cell free RNA isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles.This document is applicable to molecular in vitro diagnostic examinations 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.Different dedicated measures need to be taken during the pre-examination phase for isolated RNA from enriched exosomes and other extracellular vesicles enriched from venous whole blood and for cellular RNA isolated from venous whole blood. These are not described in this document but are covered in CEN/TS 17747,1 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - Isolated DNA, RNA and proteins, and in EN ISO 20186-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA.NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.