Norm

CEN/TS 16835-1:2015 en

Moleculair in vitro diagnostisch onderzoek - Specificatie voor de pre-onderzoeksprocessen voor veneus heel bloed - Deel 1: Geïsoleerd cellulair RNA.

52,00

Over deze norm

Status Definitief
Aantal pagina's 20
Commissie In vitro diagnostica
Gepubliceerd op 01-07-2015
Taal Engels
CEN/TS 16835-1 recommends the handling, documentation and processing of venous whole blood specimens intended for cellular RNA 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 cellular RNA profiles can change significantly after collection. Therefore, special measures need to be taken 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 in exosomes circulating in blood, which are not described in this Technical Specification. Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies. These are not described in this Technical Specification. RNA in pathogens present in blood is not covered by this Technical Specification.

Details

ICS-code 11.100.10
Nederlandse titel Moleculair in vitro diagnostisch onderzoek - Specificatie voor de pre-onderzoeksprocessen voor veneus heel bloed - Deel 1: Geïsoleerd cellulair RNA.
Engelse titel Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA

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