A-029 Evaluation of the Analytical Performance of Four Assays Used for Diabetes 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 Atellica IM C-peptide (CpS) and Insulin (IRI) Assays, and the Atellica CH Enzymatic Hemoglobin A1c (A1cE) and Fructosamine (Fruc) Assays on the Atellica CI Analyzer. Methods Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum samples, except for the A1cE assay using native and contrived human whole blood samples. One aliquot of each sample pool was tested in duplicate in two runs per day ≥2 hours apart on each analyzer for ≥20 days. Precision was evaluated using reagent lot and system combination varying between one to three reagent lots and one to three systems depending on the assay tested. Method comparison (MC) studies were performed using three reagent lots according to CLSI EP09c. Individual native and contrived human serum or whole blood (A1cE) samples were analyzed using the Atellica IM Cps, IRI Assays on the Atellica IM Analyzer, the Atellica CH A1cE, Fruc Assays on the Atellica CH Analyzer and the four Atellica IM and CH Assays presented on the Atellica CI Analyzer. 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 2. 8% and 3. 2%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusions Evaluation of the Atellica IM Cps, IRI and Atellica CH A1cE, Fruc Assays using the Atellica CI Analyzer demonstrated good precision and equivalent performance compared to the same assays on their respective Atellica CH and Atellica IM Analyzers.