Abstract

DEL CAMPILLO, Sofía et al. Especificaciones de calidad en base a error total : ¿Cuál es la mejor elección?. Acta bioquím. clín. latinoam. [online]. 2017, vol.51, n.2, pp.227-235. ISSN 0325-2957.

The aim of this work was to evaluate the annual performance of the methods in terms of total error (TE), the different quality specifications available, and the Six Sigma model to qualify performance. Analytes with very low, low, medium and high biological variability (BV) were evaluated. TE (TEc) and sigma (s) were calculated monthly at two levels of control; allowable TE (TEa) for each analyte was obtained from 8 sources (biological and regulatory goals). Acceptable performance was considered when TEc<TEa and s ≥3. Analytical stability was observed during the evaluation period. It was not possible to achieve biological targets for analytes with very low BV, and something similar happened for analytes with low and medium BV; with high BV, all specifications were met. Sigma performance and Westgard control rule election depended on the TEa; for magnesium, with CLIA (TEa=25%) s >10 was obtained (World Class) and simple rule (13s), with minimum BV s <3 and multirule. To conclude, acceptance of the method’s performance and control rules depended on the TEa chosen, without having minimum goals to achieve. The monthly monitoring of the TEc showed analytical stability with typical variability for each method.

Keywords : Quality specifications; Total error; Analytical performance; Six Sigma.

        · abstract in Spanish | Portuguese     · text in Spanish     · Spanish ( pdf )