In 2008, creatinine measurement was the fifth most common analysis in laboratory medicine in France. Creatinine is the main biomarker used for the diagnosis, follow-up and monitoring of chronic kidney disease, a serious pathology that affects approximately three million subjects in France. To avoid the evolution of chronic kidney disease to end stage renal disease, it is essential to have reliable creatinine measurements in order to allow efficient and early diagnosis. To address these challenges, the contribution of metrology is essential to improve clinical measurements reliability and comparability. First, reference methods are necessary to assign reference values to calibration materials. This is the first step to establish the metrological traceability of results to the International system of units (SI) and lead to the standardization of medical analysis. Second, reference methods are essential to assign reference values to quality control samples, providing suitable tools for assessing the accuracy of routine methods and those used by in vitro diagnostic products manufacturers.

Key words

clinical laboratory
iso 15189
external quality assessment