Measurement uncertainty in laboratory medicine: the bridge between medical and industrial metrology

Abstract

Uncertainty is an inseparable part of all types of measurements, that is, in metrology a measurement without uncertainty is not possible. Calculation of uncertainty increases the awareness of the certainty of measurement results. Reporting measurement uncertainty is mandatory in almost all industrial sectors but not in laboratory medicine. Test results without analytical uncertainty increases the diagnostic uncertainty, causing errors that could seriously affect patients health. To improve diagnostic certainty, we should calculate and upon request report measurement uncertainty to laboratory users (ISO 15189). In this mini-review, we summarized the theoretical perspective of uncertainty concept, its relation to Six Sigma and finally compared it with Total Error Method.