标准编号：ISO 20186-3:2019
中文名称：分子体外诊断检查 静脉全血预检程序规范 第3部分：从血浆中分离的循环细胞游离DNA
英文名称：Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma
发布日期：2019-09
标准范围
This document provides recommendations and requirements on the handling, storage, processing
and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA)
examination during the pre-examination phase before an analytical test 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 genomic DNA, which are not described in
this document. Blood genomic DNA is covered in ISO 20186-2.
Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not
described in this document.
NOTE ccfDNA obtained from blood by the procedures cited in this document can contain DNA originally
present in exosomes .
DNA in pathogens present in blood is not covered by this document.
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