BS PD CEN/TS 16835-3:2015

BS PD CEN/TS 16835-3:2015 recommends the handling, documentation and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification covers specimens collected by venous whole blood collection tubes. 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 regulatory authorities).

Blood ccfDNA profiles can change significantly after blood collection from the donor (e.g. release of genomic DNA from white blood cells, ccfDNA fragmentation and ccfDNA quantity change). Special measures 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 not described in this Technical Specification. Blood genomic DNA is covered in CEN/TS 16835-2, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA

NOTE CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes [3] [4].

DNA from pathogens present in blood is not covered by this Technical Specification.


Cross References:
EN ISO 15189:2012
ISO 15189:2012
ISO 15190
EN ISO 22174:2005
ISO 22174:2005
ISO Guide 30:2015
SRM 2372


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