A-128 Analytical Performance Evaluation of Assays Used for Iron Studies on the Atellica® CI 1900 Analyzer

Abstract Background The Atellica® CI 1900 Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer employing both Atellica CH and Atellica IM assays. This study was designed to evaluate the analytical performance of the Atellica CH Iron_2 (Iron_2), Total Iron Binding Capacity (TIBC), and Transferrin (Trf) assays* and the Atellica IM Ferritin (Fer) assay on the Atellica CI 1900 Analyzer. Methods The Atellica CI 1900 Iron_2, TIBC, and Trf assays use the same reagents and calibrators as the comparable Atellica chemistry assays. The Atellica CI 1900 Fer assay uses the same reagents and calibrators as the Atellica immunoassay. 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. MC studies were performed according to CLSI EP09-A3. Native and contrived human samples were analyzed using the Atellica CH Iron_2, TIBC, and Trf assays on both the Atellica® CH 930 and Atellica CI 1900 Analyzers. For Fer, native and contrived human samples were analyzed using the Atellica IM Fer assay on both the Atellica® IM 1600 and Atellica CI 1900 Analyzers. Results Representative precision and MC results for each assay are listed in the table. For the four assays tested, repeatability and within-lab %CVs were