Uwe Oelmueller - BIOBANQUES May 17, 2016


Biobanking National Infrastructure Meeting

Quality matters: Improving the quality of biological resources


Standardized improved pre-analytical workflows: the bridge to good quality samples for reliable analytical test results.

Molecular in vitro diagnostics and biomedical research have allowed great progress in medicine. Further progress is expected by new biomarker tests analyzing cellular biomolecule profiles such as nucleic acids, proteins, and metabolites. However, profiles of these molecules can change significantly during sample collection, transport, storage, archiving and processing, caused by post collection cellular changes such as gene inductions, gene down regulations, biomolecules modifications or degradation. This can make the outcome from diagnostics or research unreliable or even impossible because the analytical test will not determine the situation in the patient but an artificial bioanalyte profile generated during the pre-analytical process. High quality clinical samples with preserved bioanalyte profiles are therefore critical to biobanking, research and diagnostics. The EU FP7 SPIDIA consortium could achieve significant progress by developing new pre-analytical workflow technologies and by generating evidence for developing new standards. The European Committee CEN/TC 140 “In vitro Diagnostic Medical Devices” has released first 9 Technical Specification documents addressing pre-analytical workflows for different blood, other body fluids and tissue based molecular applications. They are currently under further development to International Standards within the ISO/Technical Committee 212 “Clinical Laboratory Testing and In Vitro Diagnostic Test Systems”.  The presentation will give an overview about SPIDIA’s and thereon build other international project’s achievements and future work.



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