A-125 Analytical Performance of Chemistry Assays Comprising the Basic Metabolic Panel on the Atellica CI 1900 Analyzer

Abstract

Abstract Background The Atellica® CI 1900 Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer utilizing both Atellica CH and Atellica IM assays. This study was designed to evaluate the analytical performance of the Atellica CH Urea Nitrogen (UN_c), Creatinine (CREA_2), Enzymatic Creatinine (ECre_3), A-LYTE™ Multisensor (IMT Na K Cl), Carbon Dioxide (CO2_c), Glucose Oxidase (GluO), Glucose Hexokinase_3 (GluH_3), and Calcium_2 (CA_2) assays* on the Atellica CI 1900 Analyzer*. Methods The Atellica CI 1900 CH UN_c, CREA_2, ECre_3, IMT Na K Cl, CO2_c, GluO, GluH_3, and CA_2 assays use the same reagents and calibrators as the Atellica CH assays. Precision and method comparison (MC) were used as performance indicators for the Atellica CI 1900 Analyzer. Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum samples. One aliquot of each sample pool was tested in duplicate in two runs per day >2 h apart on each analyzer for >20 days. MC studies were performed according to CLSI EP09-A3. Individual native and contrived human serum samples were analyzed using the Atellica CH assays on both the Atellica CH and Atellica CI 1900 Analyzers. Results Representative precision and MC results are listed for each assay in the table. Over the 10 assays tested, repeatability and within-lab %CVs were <5.0% and <6.0%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusion Evaluation of the Atellica CH UN_c, CREA_2, ECre_3, IMT Na K Cl, CO2_c, GluO, GluH_3, and CA_2 assays using the Atellica CI 1900 Analyzer demonstrated good precision and equivalent performance compared to the same assays on the Atellica CH Analyzer. *The products mentioned are not commercially available in all countries. Their future availability cannot be guaranteed.