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Technische Regel
ONR CEN/TS 16835-2
Issue date: 2015 12 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA
This Technical Specification recommends the handling, documentation and processing of venous whole blood specimens intended for genomic DNA analysis during the preanalyti...
Withdrawn: 2019 08 01
Publisher:
Austrian Standards International
Format:
Digital | 21 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 genomic DNA 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 genomic DNA can fragment or degrade after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for genomic DNA analysis. This is particularly relevant for analytical test procedures requiring high molecular weight DNA.
Different dedicated measures need to be taken for preserving blood circulating cell free DNA, which are not described in this Technical Specification. Circulating cell free DNA in blood is covered in CEN/TS 16835-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma.
Different dedicated measures need to be taken for collecting, stabilizing, transporting and storing capillary blood as well as for blood collected and stored by paper based technologies. These are not described in this Technical Specification.
DNA from pathogens present in blood is not covered by this Technical Specification.
ÖNORM EN ISO 20186-2
2019 08 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous...
Norm
ONR CEN/TS 16835-2
2015 12 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous...
Technische Regel
↖
ONR CEN/TS 16835-2
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 :
2019 08 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic RNA (ISO 20186-2:2019)