标准编号：ISO 20186-2:2019
中文名称：分子体外诊断试验 静脉全血预检验程序规范 第2部分：分离基因组DNA
英文名称：Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA
发布日期：2019-02
标准范围
This document gives guidelines on the handling, storage, processing and documentation of venous
whole blood specimens intended for genomic DNA examination during the pre-examination phase
before a molecular examination is performed. This document covers specimens collected in venous
whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination 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 are taken for stabilizing blood cell free circulating DNA, which are not
described in this document.
NOTE Circulating cell free DNA in blood is covered in ISO 20186-3.
Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary
blood as well as for collecting and storing blood by paper based technologies or other technologies
generating dried blood. These are not described in this document.
This document does not cover the isolation of specific blood cells and subsequent isolation of genomic
DNA therefrom.
DNA in pathogens present in blood is not covered by this document.
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