Defining permissible limits for the combined uncertainty budget in the implementation of metrological traceability

Abstract

In addition to the correct implementation of calibration traceability, the definition and the achievement of an appropriate analytical performance specification for the total uncertainty budget (G_U) is essential to ensure that laboratory measurements are clinically usable. To understand if it is possible to fulfil these specifications, limits for combined uncertainty across the entire metrological traceability chain should be defined. We recommended that no more than one third of G_U should be consumed by the uncertainty of higher order references and ≤50% of G_U by the combined measurement uncertainty at the manufacturer's calibration level. The remaining allowable uncertainty should be available for random sources, i.e. for the imprecision of the commercial measuring system (including the reagent batch-to-batch variation) and the individual laboratory performance, as a safety margin to fulfil G_U. Based on this approach, it is of interest to assess for each analyte measured in the clinical laboratory the status of the uncertainty budget of its measurement associated with the selected metrological traceability chain. Accordingly, we report three didactic cases that could occur in the clinical practice. This approach is very helpful to identify those analytes for which further technological improvements are probably needed to reduce uncertainty associated with their measurement.

Keywords: Measurement uncertainty; Performance specifications; Standardization.