DIN Standards Committee Health Technologies
DIN CEN/TS 16835-2
; DIN SPEC 13225-2:2015-12
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA; German version CEN/TS 16835-2:2015
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für venöse Vollblutproben - Teil 2: Isolierte genomische DNS; Deutsche Fassung CEN/TS 16835-2:2015
Procedure
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Overview
This Technical Specification provides recommendations on the handling, documentation and processing of blood specimens intended for genomic DNA analysis during the pre-examination phase, namely before a molecular examination is performed. This Technical Specification is applicable to molecular in vitro diagnostic methods (for example, in in vitro diagnostics laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organizations performing biomedical research, biobanks and regulatory authorities). The profiles of the genomic DNA can change drastically prior and during sampling (for example DNA fragmentation. Therefore, special measures for quality assurance of blood specimens for the following analyses of genomic DNA shall be taken. Circulating cell free DNA in blood is covered in DIN CEN/TS 16835-3. Other specific measures which are not described here shall be carried out for preservation of the circulating free cell DNA. DNA in pathogens present in blood is not covered by this Technical Specification.
Document: references other documents
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140/WG 3 - Quality management in the medical laboratory
