B-024 An Evaluation of the Analytical Performance of the New Beckman Coulter DxC 500 AU Clinical Chemistry System

Abstract

Abstract Background The Beckman Coulter DxC 500 AU clinical chemistry analyzer* is the latest system from Beckman Coulter. It is a fully automated, random-access analyzer, designed for low to medium throughput laboratories, with a throughput of 800 tests/hour including ion selective electrodes. The purpose of this study was to evaluate the analytical performance of the new DxC 500 AU and to compare the performance against the current AU480 and DxC 700 AU analyzers. Methods To assess the performance of the DxC 500 AU, Beckman Coulter assays were selected for evaluation that covered a range of sample types and assay methodologies. Precision was assessed using pooled human samples over 20 days following CLSI guideline EP05-A3. The linear range was assessed following CLSI EP06-A. The DxC 500 AU was compared to the AU480 and DxC 700 AU analyzers using a minimum of 100 samples spanning the dynamic range based on CLSI guideline EP09c-ED3. Results IgG Serum: OSR6x172 Estimates of repeatability and within laboratory precision were assessed following EP05-A3 at multiple critical analyte concentrations. The IgG serum assay exhibits total imprecision of < 6 % with a within run imprecision of ≤ 3.5 %. The IgG serum assay demonstrated acceptable linearity throughout the analytical measuring range of 75 to 3000 mg/dL following CLSI EP06-A. A method comparison study following CLSI EP09c-ED3 compared the IgG serum assay on the DxC 500 AU against the AU480 and DxC 700 AU. Serum patient samples (n > 100) measured across the analytical range were analyzed using Weighted Deming regression and yielded a slope of 1.046, an intercept of −20.2884 mg/dL and correlation coefficient R = 0.9979 against the DxC 700 AU and yielded a slope of 1.005, an intercept of −3.6578 mg/dL and correlation coefficient R = 0.9973 against the AU480. CRP Serum (Highly Sensitive): OSR6x99 Estimates of repeatability and within laboratory precision were assessed following EP05-A3 at multiple critical analyte concentrations. The CRP serum assay exhibits total imprecision of ≤10 %CV or ≤0.02 SD with a within run imprecision of ≤5 %CV or ≤0.02 SD. The CRP serum assay demonstrated acceptable linearity throughout the analytical measuring range of 0.2 to 80 mg/L following CLSI EP06-A. A method comparison study following CLSI EP09c-ED3 compared the CRP serum assay on the DxC 500 AU against the AU480 and DxC 700 AU. Serum patient samples (n > 100) measured across the analytical range were analyzed using Weighted Deming regression and yielded a slope of 0.990, an intercept of 0.0421 mg/dL and correlation coefficient R = 0.9997 against the DxC 700 AU and yielded a slope of 0.995, an intercept of −0.0008 mg/dL and correlation coefficient R = 0.9998 against the AU480. Conclusion The results of the study demonstrated excellent analytical performance of the new Beckman Coulter DxC 500 AU analyzer and confirms comparable performance to the AU480 and DxC 700 AU analyzers. *Product In development. Pending clearance by the United States Food and Drug Administration and achievement of CE compliance. Not currently available for in vitro diagnostic use.