Multi-center evaluation of analytical performance of the Beckman Coulter AU5822 chemistry analyzer

Abstract

Objectives Our three academic institutions, Indiana University, Northwestern Memorial Hospital, and Wake Forest, were among the first in the United States to implement the Beckman Coulter AU5822 series chemistry analyzers. We undertook this post-hoc multi-center study by merging our data to determine performance characteristics and the impact of methodology changes on analyte measurement. Design and methods We independently completed performance validation studies including precision, linearity/analytical measurement range, method comparison, and reference range verification. Complete data sets were available from at least one institution for 66 analytes with the following groups: 51 from all three institutions, and 15 from 1 or 2 institutions for a total sample size of 12,064. Results Precision was similar among institutions. Coefficients of variation (CV) were < 10% for 97%. Analytes with CVs > 10% included direct bilirubin and digoxin. All analytes exhibited linearity over the analytical measurement range. Method comparison data showed slopes between 0.900-1.100 for 87.9% of the analytes. Slopes for amylase, tobramycin and urine amylase were < 0.8; the slope for lipase was > 1.5, due to known methodology or standardization differences. Consequently, reference ranges of amylase, urine amylase and lipase required only minor or no modification. Conclusion The four AU5822 analyzers independently evaluated at three sites showed consistent precision, linearity, and correlation results. Since installations, the test results had been well received by clinicians from all three institutions.