PD CEN/TS 16835-2:2015
分子体外诊断检查.静脉全血预审流程的规范.第2部分:脱氧核糖核酸染色体组的分离

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA

标准号

PD CEN/TS 16835-2:2015

发布

2015年

发布单位

欧洲标准化委员会

当前最新

PD CEN/TS 16835-2:2015

 

 

引用标准

EN ISO 15189:2012 EN ISO 22174:2005 ISO 15190:2003 ISO Guide 30:2015

被代替标准

FprCEN/TS 16835-2-2015

适用范围

This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for genomic DNA 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 genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysis. This is particularly relevant for analytical test procedures requiring high molecular weight DNA. Different dedicated measures need to be taken for preserving blood circulating cell free DNA, which are not described in this Technical Specification. Circulating cell free DNA in blood is covered in CEN/TS 16835-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for blood collected and stored by paper based technologies. These are not described in this Technical Specification. DNA from pathogens present in blood is not covered by this Technical Specification.

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