DANSK DSF/FPREN ISO 20186-2 PDF

This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for genomic DNA analysis examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by (e.g., medical laboratories. It is also intended to be used by, laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organizsations 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 analysisexamination. This is particularly relevant for analytical test procedures requiring high molecular weight DNA. Different dedicated measures have to be taken for preserving blood cell free circulating DNA, which are not described in this International Standard. Circulating cell free DNA in blood is covered in ISO 20091-3, 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, stabilizsing, 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 International Standard. Pathogen DNA present in blood is not covered by this International Standard. NOTE – International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.