A-124 Evaluation of the Analytical Performance of 10 General Chemistry Assays on the Atellica® CI 1900 Analyzer

Abstract

Abstract Background The Atellica® CI 1900 Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer employing both Atellica chemistry and Atellica immuno assays. This study was designed to evaluate the analytical performance of the Atellica CH Alkaline Phosphatase concentrated (ALP_2c), Direct Bilirubin 2 (DBil_2), Total Bilirubin_2 (TBil_2), Albumin (Alb), Albumin BCP (AlbP), Total Protein II (TP), Aspartate Aminotransferase (AST), Aspartate Aminotransferase P5P (ASTPLc), Alanine Aminotransferase (ALT), and Alanine Aminotransferase P5P (ALTPLc) assays* on the Atellica CI 1900 Analyzer. Methods The Atellica CI 1900 ALP_2c, DBil_2, TBil_2, Alb, AlbP, TP, AST, ASTPLc, ALT, and ALTPLc assays use the same reagents and calibrators as the Atellica Chemistry 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 930 and Atellica CI 1900 Analyzers. Results Representative precision and MC results are listed for each assay in the table below. For the nine assays tested, repeatability and within-lab %CVs were <6.0% and <9.0%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusion Evaluation of the Atellica CH ALP_2c, DBil_2, TBil_2, Alb, AlbP, TP, AST, ASTPLc, ALT, and ALTPLc assays using the Atellica CI 1900 Analyzer demonstrated acceptable precision and equivalent performance compared to the same assays on the Atellica CH 930 Analyzer. *The products mentioned are not commercially available in all countries. Their future availability cannot be guaranteed.