B-332 Evaluation of the Analytical Performance of Seven Therapeutic Drug Monitoring 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 employing both Atellica CH and Atellica IM assays. This study was designed to evaluate the analytical performance of the Atellica CH Vancomycin (Vanc), Carbamazepine (Carb), Gentamicin (Gent), Phenytoin (Phny), Tobramycin (Tob), Valproic Acid (VPA), and Theophylline (Theo) assays* on the Atellica CI 1900 Analyzer. Methods The Atellica CI 1900 Vanc, Carb, Gent, Phny, Tob, VPA, and Theo assays use the same reagents and calibrators as the Atellica chemistry 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 serum 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 serum samples were analyzed using the Atellica chemistry assays on both the Atellica CH and Atellica CI 1900 Analyzers. Precision and MC were evaluated with three reagent lots on one system. Results Representative precision and MC results observed from one reagent lot across indicated sample ranges are listed in the table below for each assay. Over the seven assays tested, repeatability and within-lab % CVs were <6.5% and <11.0%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Conclusion Evaluation of the Atellica CH Vanc, Carb, Gent, Phny, Tob, VPA, and Theo assays using the Atellica CI 1900 Analyzer demonstrated good precision and equivalent performance compared to the same assays on the Atellica CH 930 Analyzer.*The products/features mentioned here are not commercially available in all countries. Their future availability cannot be guaranteed.