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Technische Regel
ONR CEN/TS 16835-3
Issue date: 2015 12 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (CEN/TS 16835-3:2015)
This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) analysi...
Withdrawn: 2020 03 15
Publisher:
Austrian Standards International
Format:
Digital | 19 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This Technical Specification 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
DNA from pathogens present in blood is not covered by this Technical Specification.
ÖNORM EN ISO 20186-3
2020 03 15
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous...
Norm
ONR CEN/TS 16835-3
2015 12 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous...
Technische Regel
↖
ONR CEN/TS 16835-3
2015 06 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous...
Technische Regel Entwurf
Norm
Issue date :
2014 12 01
Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
Norm
Issue date :
2020 03 15
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019)