A Practical Way to ISO/GUM Measurement Uncertainty for Analytical Assays Including In-House Validation Data

In this contribution, we outline the estimation of measurement uncertainty of analytical assays in a practical way, according to the so-called reconciliation paradigm, by considering the heritance of uncertainties according to the ISO Guide to the expression of uncertainty in measurement (ISO/GUM) approach and the accuracy (bias and precision) study coming from the in-house method validation. A cause and effect analysis is performed by using the Ishikawa diagram or fishbone plot, consisting of a hierarchical structure reaching a final outcome that is the analytical result. The procedure is illustrated with a case study. This procedure may be very suitable for processing data in accreditation of routine assays.

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