A-218 Analytical Performance Evaluation of Lipid Panel Assays on the Atellica CI 1900 Analyzer

Abstract

Abstract Background The Atellica® CI 1900 Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer utilizing both Atellica CH and Atellica IM assays. This study was designed to evaluate the analytical performance of the Atellica CH Creatinine (CREA_2)*, Enzymatic Creatinine (ECre_3)*, Urinary/Cerebrospinal Fluid Protein (UCFP)*, and Microalbumin_2 (µALB_2)* assays on the Atellica CI 1900 Analyzer*. Methods The Atellica CI 1900 CH CREA_2, ECre_3, UCFP, and µALB_2 assays use the same reagents and calibrators as the Atellica CH assays. 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 urine samples. One aliquot of each sample pool was tested in duplicate in two runs per day >2 h apart on each analyzer for >20 days. MC studies were performed according to CLSI EP09-A3. Individual native and contrived human urine samples were analyzed using the Atellica CH assays on both the Atellica CH and Atellica CI 1900 Analyzers. Results Representative precision and MC results observed from one reagent lot across indicated sample ranges are listed for each assay in the table below. Over the four assays tested, repeatability and within-lab %CVs were <5.1% and <6.0%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusion Evaluation of the Atellica CH CREA_2, ECre_3, UCFP, and µALB_2 assays using the Atellica CI 1900 Analyzer demonstrated good precision and equivalent performance compared to the same assays on the Atellica CH Analyzer. *The products/features mentioned here are not commercially available in all countries. Their future availability cannot be guaranteed.