CEN/TS 16835-1-2015
分子体外诊断检查.静脉全血预审流程的规范.第1部分:核糖核酸细胞的分离

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA


 

 

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标准号
CEN/TS 16835-1-2015
发布日期
2015年07月01日
实施日期
废止日期
中国标准分类号
C38
国际标准分类号
11.100.10
发布单位
IX-CEN
引用标准
EN ISO 15189-2012 EN ISO 22174-2005 ISO Guide 30-1992 ISO 15190-2003
被代替标准
FprCEN/TS 16835-1-2015
适用范围
This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for cellular RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities). Blood cellular RNA profiles can change significantly after collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA analysis and storage. Different dedicated measures need to be taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood, which are not described in this Technical Specification. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies. These are not described in this Technical Specification. RNA in pathogens present in blood is not covered by this Technical Specification.




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