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Precision and trueness verification study of an Atellica system
Alberto Vílchez Rodríguez1, Julia González Cantó1, Sara Esteve Poblador1
1Area of Biological Diagnosis, La Ribera University Hospital, Alzira, Spain.
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.
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