Measurement Uncertainty Calculation for Twenty Clinical Chemistry Analytes Using the Real-World ISO Method

Abstract

The diagnosis, treatment, monitoring, and risk assessment of patients rely heavily on the findings of
laboratory tests conducted in clinical labs. Therefore, Reliability of measurement results and proper patient
treatment are dependent on precise and accurate regular measurements (1). The reliability and accuracy of
measurements are first assessed using total error (TE). When the measured value deviates from the precise
value, it is indicated by TE, which is a mix of random and systematic mistakes (2). In order to account for
these sources of error, Westgard et al. (3) defined TE as the sum of the observed bias plus two standard
deviations. In order to compute the TE, one must be aware of the precise value of the measurement data. The
idea of measurement uncertainty (MU) is another way to evaluate the precision of a measurement. It's a nonnegative parameter linked to the measurement's outcome that defines the range of values that can be rationally
attributed to the measurement (2). The absence of a completely correct value of the findings is emphasised
by MU, which operates on the assumption that the precise value of the test results cannot be known (1).
Measurement uncertainty (MU) is the range of possible measurable values for a given analyte, and the equal
likelihood of obtaining values within this range (4). If a result considerably differs from accuracy, it may be
determined by comparing it with permissible analytical performance standards (APS), much as with the TE
concept (5). There should be proper evaluation of MU values of test results in routine laboratory practices,
according to international accreditation bodies like JCGM, ISO, and ILAC (6-8).