DIN CEN/TS 16835-3*DIN SPEC 13225-3:2015-12

This Technical Specification recommends the handling, documentation and processing of blood specimens intended for circulating cell free DNA (ccfDNA) 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 ccfDNA can change significantly after collection (e. g. ccfDNA fragmentation, ccfDNA quantity, release of genomic DNA from white blood cells). Special measures have to be taken to secure good quality blood samples for ccfDNA analysis.