Precision and trueness verification study of an Atellica system

Autor: Julia González Cantó, Alberto Vílchez Rodríguez, Pedro Luis Estela Burriel, Carmen Valldecabres Ortiz, Sara Esteve Poblador
Rok vydání: 2020
Předmět:
Zdroj: Advances in Laboratory Medicine, Vol 1, Iss 4 (2020)
ISSN: 2628-491X
Popis: Objectives Clinical laboratories should use only validated procedures. Precision is an important factor in the validation and verification of a new measurement procedure. Our objective was to verify the precision and trueness of different analysers used for the biochemical and immunochemical characterization of analytes. Methods Advia 1800®, Immulite®2000 and CentaurXP® analysers and the Atellica®Solution system were used. Five analytes were characterized biochemically, whereas another five analytes were characterized immunochemically. Imprecision was assessed using BioRad® and Siemens® control materials. Within-run and between-run imprecision were calculated by analysing three replicates of each control in a single run every day for five days. Bias was assessed using 40 samples of serum by the analysis of differences and linear regression. Results The within-run and between-run imprecision values obtained with the new measurement procedure were lower than the ones claimed by the manufacturer for all the analytes studied. In the bias study, a proportional but not constant systematic error was observed in some analytes. Conclusions The coefficients of variation obtained with Atellica®Solution verified both, the imprecision specifications claimed by the manufacturer and by the laboratory. The conditions of calibration should be revised for some parameters and a wider range of samples should be used.
Databáze: OpenAIRE