this document gives guidelines on the handling, storage, processing and documentation of venous
whole blood specimens intended for cellular rna examination during the pre-examination phase
before a molecular examination is performed. this document covers specimens collected in venous
whole blood collection tubes.
this document is applicable to any molecular in vitro diagnostic examination performed by medical
laboratories. it is also intended to be used by laboratory customers, in vitro diagnostics developers and
manufacturers, biobanks, institutions and commercial organizations performing biomedical research,
and regulatory authorities.
different dedicated measures are taken for stabilizing blood cell free circulating rna and rna in
exosomes circulating in blood. these are not described in this document.
different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary
blood as well as for collecting and storing blood by paper based technologies or other technologies
generating dried blood. these are not described in this document.
this document does not cover the isolation of specific blood cells and subsequent isolation of cellular
rna therefrom.
rna in pathogens present in blood is not covered by this document.st edition
2019-02
molecular in vitro diagnostic
examinations？—？specifications？for？
pre-examination？processes？for？venous？
whole blood —
part 1:
isolated cellular rna
analyses de diagnostic moléculaire in vitro — spécifications relatives
aux processus préanalytiques pour le sang total veineux —
partie 1: arn cellulaire extrait
reference number
iso 20186-1:2019(e)
？
iso 2019
iso 20186-1:2019