Norm

NVN-CEN/TS 16835-3:2015 en

Moleculair in vitro diagnostisch onderzoek - Specificatie voor de pre-onderzoeksprocessen voor veneus heel bloed - Deel 3 - Geïsoleerd circulerend cel vrij DNA

49,30

Over deze norm

Status Definitief
Aantal pagina's 15
Commissie In vitro diagnostica
Gepubliceerd op 01-05-2016
Taal Engels
NVN-CEN/TS 16835-3 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

Details

ICS-code 11.100.30
Nederlandse titel Moleculair in vitro diagnostisch onderzoek - Specificatie voor de pre-onderzoeksprocessen voor veneus heel bloed - Deel 3 - Geïsoleerd circulerend cel vrij DNA
Engelse titel Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma

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