B-340 Evaluation of the Analytical Performance of Three Major Immunoglobulins Assays on the Atellica CI Analyzer

Abstract

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 Immunoglobulin A_2 (IgA_2), Immunoglobulin G_2 (IgG_2), and Immunoglobulin M_2 (IgM_2) 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 studies were performed using three reagent lots according to CLSI EP09c. Individual native and contrived human serum samples were analyzed using the Atellica CH IgA_2, IgG_2, and IgM_2 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 method comparison results for each assay are listed in the table. For the three assays tested, repeatability and within-lab %CVs were <1.8% and <3.9%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Detection capability for the Atellica CH IgA_2 Assay on the Atellica CI Analyzer was estimated at 1.6 mg/dL (0.02 g/L) and 3.6 mg/dL (0.04 g/L) for LoB, and LoD. For the Atellica CH IgG_2 Assay, LoB and LoD were determined at 7 mg/dL (0.07 g/L) and 21 mg/dL (0.21 g/L). For the Atellica CH IgM_2 Assay, LoB and LoD were determined at 5.0 mg/dL (0.05 g/L) and 8.0 mg/dL (0.08 g/L). Conclusions Evaluation of the Atellica CH IgA_2, IgG_2, and IgM_2 Assays using the Atellica CI Analyzer demonstrated good precision and equivalent performance compared to the same assays on the Atellica CH Analyzer.