BS PD CEN/TS 16835-2:2015

This Technical Specification recommends the handling, documentation and processing of venous wholeblood specimens intended for genomic DNA analysis during the preanalytical phase before a molecularassay is performed. This Technical Specification covers specimens collected by venous whole bloodcollection tubes. This Technical Specification is applicable to molecular in vitro diagnostic examinations(e.g. in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers andmanufacturers, institutions and commercial organizations performing biomedical research, biobanks,and regulatory authorities).Blood genomic DNA can fragment or degrade after blood collection. Therefore, special measures need tobe taken to secure good quality blood samples for genomic DNA analysis. This is particularly relevantfor analytical test procedures requiring high molecular weight DNA.Different dedicated measures need to be taken for preserving blood circulating cell free DNA, which arenot described in this Technical Specification. Circulating cell free DNA in blood is covered inCEN/TS 16835-3, Molecular in vitro diagnostic examinations - Specifications for pre-examinationprocesses for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma.Different dedicated measures need to be taken for collecting, stabilizing, transporting and storingcapillary blood as well as for blood collected and stored by paper based technologies. These are notdescribed in this Technical Specification.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 30:2015