A-128 Evaluation of the Analytical Performance of Three Inflammation Related Assays on the Atellica CI Analyzer

Abstract Background The Atellica® CI Analyzer is an automated, high-throughput integrated chemistry and immunoassay analyzer utilizing both Atellica® CH and Atellica® IM Assays. This study evaluated the analytical performance of the the Atellica CH Complement C3 (C3), Complement C4 (C4), and Alpha-1-acid Glycoprotein (AAG) Assays on the Atellica CI Analyzer. Methods Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum samples. One aliquot of each sample was tested in duplicate in two runs per day ≥2 hours apart on each analyzer for ≥20 days. Precision was evaluated using three reagent lots on one system. Method comparison (MC) studies were performed using three reagent lots according to CLSI EP09c. Individual native and contrived human serum samples were analyzed using the Atellica CH C3, C4, and AAG Assays on the Atellica CH Analyzer and the Atellica CI Analyzer. LoB and LoD were determined as described in CLSI EP17-A2. Results Representative precision and MC results for each assay are listed in the table. For the three assays tested, repeatability and within-lab %CVs were