DIN CEN/TS 16835-2*DIN SPEC 13225-2:2015-12

This Technical Specification recommends the handling, documentation and processing of blood specimens intended for genomic DNA analysis during the pre-analytical phase before a molecular assay is performed. 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 regulation authorities). Blood genomic DNA can change after collection (e. g. DNA fragmentation). Special measures have to be taken to secure good quality blood samples for genomic DNA analysis. Circulating cell free DNA in blood is covered in (ccfDNA TS). Different dedicated measures have to be taken for preserving cell free circulating DNA, then it is described here. Pathogen DNA present in blood is not covered by this Technical Specifications.