A-028 Evaluation of the Analytical Performance Iron3, Vitamin B12, and Homocysteine Assays on the Atellica CI Analyzer

Abstract Background The Atellica® CI Analyzer is an automated, mid-throughput integrated chemistry and immunoassay analyzer employing both Atellica® CH and Atellica® IM assays. This study evaluated the analytical performance of the Atellica® CH Iron3, and Atellica® IM Vitamin B12 (VB12) and Homocysteine (HCY) assays on the Atellica CI Analyzer. Methods The Atellica CI assays use the same reagents and calibrators as Atellica CH and Atellica IM assays. Precision studies followed CLSI EP05-A3; human contrived and serum samples were tested in duplicate in 2 runs per day for 20 days. Method comparison (MC) studies used human serum samples according to CLSI EP09c and EP09-A3. MC involved comparing the Atellica CH Iron3 Assay on the Atellica CH and Atellica CI Analyzers. MC also compared Atellica IM VB12 and HCY assays on the Atellica CI with Atellica IM Analyzer. Detection capability and linearity were determined. Results Representative precision and MC results are listed for each assay in the table. Slopes determined using the Deming linear regression model were approximately equal to 1. LoB, LoD, LoQ were 2, 4, 5 µg/dL (0.4, 0.7, 0.9 µmol/L) for Iron3, 45, 90, 90 pg/mL (33, 66, 66 pmol/L) for VB12, and 0.50, 1.00, 1.00 µmol/L for HCY; linearity was 5-1000 µg/dL (0.9-179.0 µmol/L), 45-2000 pg/mL (33-1476 pmol/L), and 0.50-65.00 µmol/L, respectively. Conclusions Atellica IM Iron3, VB12, and HCY Assays on the Atellica CI Analyzer demonstrated good precision and equivalent performance to the Atellica CH Analyzer.