Metrological reference values for estimating measurement bias in clinical laboratory sciences

Abstract

Clinical laboratory quantities are measured for monitoring or diagnostic purposes. In both cases, a modification of the measurement bias can generate a false interpretation of measurement results. On the other hand, in clinical laboratory sciences, one of the most frequently used metrological reference value for calculating measurement bias is a conventional value that corresponds to the called consensusvalue. But this selection probably is not the best one, and some clinical and biological considerations should be made to decide the requirement for maximum permissible measurement bias and to decide the more appropriate metrological reference value. In the clinical laboratory, the medical relevance of the measurement bias of any measurement system in use depends on the measurement bias with which the biological reference values were produced. This dependence is due to the necessity that, for interpretation purposes, the current measurement bias should be the same that is included in the biological reference limits. For this reason, it is necessary to control the changes of bias during the life span of a measuring system. Several scenarios are described for the different estimations of bias.