Evaluación del comportamiento en términos de error total y 6Sigma y estimación de la incertidumbre de medida de 16 magnitudes de bioquímica clínica

Abstract

Within the analytical quality system of the clinical analysis laboratories, it is usual to calculate Total Error (ET) and Six sigma (6Sigma). The estimation of the measurement uncertainty (U) is a parameter that should be incorporated as part of the quality management, and is a requirement of ISO 15189. The U provides a range of probable values where the true value of a measurement result can be obtained, providing a quantitative value of the level of doubt for each value. The objective of this work is to evaluate the performance of 16 analytical methods using the calculation of the ET and the 6Sigma, as well as the U, based on an approximation model of the Nordtest guide. Internal (CCI) and external quality control (EQA) data were used. Quality requirements (ETa) based on CLIA and biological variability (BV) were used to evaluate the performance of the methods. The 16 methods presented acceptable performance, with the ET values obtained being lower than the proposed ETa and the 6Sigma values ≥ 3. Three methods have values of 6Sigma between 3 and 4, 2 methods between 4 and 5Sigma, five values between 5 and 6Sigma, and six had 6Sigmas greater than 6. The uncertainties associated with all measurements provide complementary information about the range of values in which the true value is found.