DIN CEN/TS 16835-3
; DIN SPEC 13225-3:2015-12
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma; German version CEN/TS 16835-3:2015
Molekularanalytische in-vitro-diagnostische Verfahren - Spezifikationen für präanalytische Prozesse für venöse Vollblutproben - Teil 3: Aus Plasma isolierte zirkulierende zellfreie DNS; Deutsche Fassung CEN/TS 16835-3:2015
Procedure
VN
Overview
This Technical Specification provides recommendations on the handling, documentation and processing of blood specimens intended for circulating cell free DNA (ccfDNA) 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). ccfDNA in blood can change drastically prior and during sampling (for example ccfDNA fragmentation, ccfDNA quantity, release of genomic DNA from cells in white blood cells). Therefore, special measures for quality assurance of blood specimens for the following ccfDNA analyses shall be taken.
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
