A-222 Evaluation of the Analytical Performance of Apolipoprotein A-1, Apolipoprotein B, and Lipoprotein(a) Assays on the Atellica CI Analyzer

Abstract Background This study evaluated the analytical performance of the Atellica® CH Apolipoprotein A-1 (APO A1), Apolipoprotein B (APO B), and Lipoprotein(a) (Lp(a)) assays on the Atellica® CI Analyzer. Methods The Atellica CI assays use the same reagents and calibrators as the Atellica CH assays. Precision studies were performed according to CLSI EP05-A3 using human serum samples. Each sample was tested in duplicate in two runs per day for 20 days. MC studies were performed according to CLSI EP09-A3. Individual serum samples were analyzed using Atellica® CH and Atellica CI Analyzers. Results Across the three assays, repeatability CVs were 1.3%, within-lab CVs were 2.5%. Representative precision, and MC results observed for each assay across indicated sample ranges are presented in the table. Overall, slopes determined using the Deming linear regression model were approximately equal to 1. Conclusions Atellica CH APO A1, APO B, and Lp(a) Assays on the Atellica CI Analyzer demonstrated good precision and equivalent performance to the same assays on the Atellica CH Analyzer.