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DIN CEN/TS 16945 DIN SPEC 13228:2016-11

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DIN CEN/TS 16945 DIN SPEC 13228:2016-11

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma; German version CEN/TS 16945:2016

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This Technical Specification gives recommendations for the handling, documentation and processing of urine, plasma and serum generated from whole blood intended for metabolomics analysis during the pre-analytical phase before metabolomic profiling is performed. This Technical Specification is applicable to molecular diagnostic examinations (e. g. in-vitro diagnostic laboratories, laboratory customers, in-vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulation authorities). The concentration of some metabolites can undergo significant changes after collection, as an answer to different operating procedures. Special measures have to be taken to secure good quality of urine, serum and plasma samples for the metabolomics analysis of this biofluids.

Author DIN
Editor DIN
Document type Standard
Format File
ICS 11.100.10 : In vitro diagnostic test systems
Number of pages 21
Cross references CEN/TS 16945 (2016-05), IDT
Set MYSTD-20STD
Year 2016
Document history
Country Germany
Keyword 16945