About traceability of the biochemical measurement results – some case studies on the metrological and practical aspects

Abstract

The comparability of biochemical measurement results performed by any medical laboratories could be reached only when common reference systems can be established for worldwide use. There is recognised a critical step in the reference systems to achieve traceability of values obtained using reference measurement procedures and reference materials traceable to the universally recognized and accepted reference point such as SI units. The IVD Directive requires traceability of the values assigned to calibrators and/or control materials. It must be assured through available reference measurement procedure and/or available reference materials of a higher order. In this respect, the JCTLM promote and give guidance on internationally recognized and accepted equivalence of measurements in laboratory medicine and traceability to appropriate measurement standards. There are already established higher order metrological reference materials, reference measurement procedures as well as reference measurement services for some biochemical analytes. In laboratories medicine, the metrological traceability and the related metrological concept measurement uncertainty are not always possible to be established. In this paper some traceability case studies for biochemical constituents are presented in opposite with some case studies for hematology measurements performed in medical laboratories.