BS PD CEN/TS 16835-3:2015

BS PD CEN/TS 16835-3:2015 recommends the handling, documentation and processing of venouswhole blood specimens intended for circulating cell free DNA (ccfDNA) analysis during thepreanalytical phase before a molecular assay is performed. This Technical Specification coversspecimens collected by venous whole blood collection tubes. This Technical Specification is applicableto molecular in vitro diagnostic examinations (e.g. in vitro diagnostic laboratories, laboratorycustomers, in vitro diagnostics developers and manufacturers, institutions and commercialorganizations performing biomedical research, biobanks, and regulatory authorities).Blood ccfDNA profiles can change significantly after blood collection from the donor (e.g. release ofgenomic DNA from white blood cells, ccfDNA fragmentation and ccfDNA quantity change). Specialmeasures need to be taken to secure good quality blood samples for ccfDNA analysis and storage.Different dedicated measures need to be taken for preserving blood genomic DNA. These are notdescribed in this Technical Specification. Blood genomic DNA is covered in CEN/TS 16835-2, Molecularin vitro diagnostic examinations - Specifications for pre-examination processes for venous wholeblood - Part 2: Isolated genomic DNANOTE CcfDNA obtained from blood by the procedures suggested in this document can contain DNA presentin exosomes [3] [4].DNA from pathogens present in blood is not covered by this Technical Specification.Cross References:EN ISO 15189:2012ISO 15189:2012ISO 15190EN ISO 22174:2005 ISO 22174:2005ISO Guide 30:2015SRM 2372