BS PD CEN/TS 16835-1:2015

BS PD CEN/TS 16835-1:2015 recommends the handling, documentation and processing of venous whole bloodspecimens intended for cellular RNA analysis during the preanalytical phase before a molecular assay isperformed. 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 diagnosticlaboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions andcommercial organizations performing biomedical research, biobanks, and regulatory authorities).Blood cellular RNA profiles can change significantly after collection. Therefore, special measures need to betaken to secure good quality blood samples for cellular RNA analysis and storage.Different dedicated measures need to be taken for stabilizing blood cell free circulating RNA and RNA inexosomes circulating in blood, which are not described in this Technical Specification.Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillaryblood as well as for collecting and storing blood by paper based technologies. These are not described in thisTechnical Specification.RNA in pathogens present in blood is not covered by this Technical Specification.Cross References:EN ISO 15189:2012ISO 15189:2012ISO 15190EN ISO 22174:2005 ISO 22174:2005