A-023 Performance Evaluation of the Atellica IM High-Sensitivity Troponin I Assay on the Atellica CI 1900 Analyzer

Abstract

Abstract Background The Atellica® CI 1900 Analyzer is an automated, high-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 IM High Sensitivity Troponin I (TnIH) assay* on the Atellica CI 1900 Analyzer*. Methods Precision and method comparison were used as performance indicators for the Atellica CI 1900 Analyzer. Precision studies were performed according to CLSI EP05-A3 and method comparison according to CLSI EP09-A3. Precision studies used a panel of four native and one contrived serum/lithium-heparin plasma 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 with two reagent lots on two systems. For the method comparison, individual native human lithium-heparin plasma samples were analyzed using the Atellica IM TnIH assay on both the Atellica IM and Atellica CI 1900 Analyzers. Detection capability studies including limit of blank (LoB), limit of detection (LoD), and 20-day functional sensitivity (LoQ) were performed according to CLSI EP17-A2 guidelines. Expected values of normal healthy individuals and hook effect were also verified on the Atellica CI 1900 Analyzer. Results Repeatability and within-lab %CVs ranged from 0.7% to 4.4% and 1.3% to 5.1%, respectively, at TnIH concentrations ranging from 13.73 to 23 197.12 ng/L. Method comparison between the Atellica IM TnIH assay on the Atellica CI 1900 Analyzer vs the Atellica IM Analyzer showed a regression slope of 1.00 and an intercept of 0.04 ng/L (n = 170). In detection capability studies, four lots of the Atellica IM TnIH assay on two Atellica CI 1900 analyzers showed a LoB of 0.35 ng/L and an LoD of 0.76 ng/L. LoQ, defined as the lowest amount of analyte in a sample at which within-lab %CV = 20%, was 1.10 ng/L; %CV was approximately 10% at a TNIH concentration of 2.57 ng/L. In addition, >50% of healthy individuals tested had TnIH values >LoD. The 99th percentile for the Atellica IM TnIH assay (45.20 ng/L) was verified on Atellica CI 1900 Analyzer and was consistent with the Atellica IM Analyzer. No interference from biotin was observed up to a concentration of 3500 ng/mL, and no hook effect was observed up to a concentration of 500 000 ng/L. Conclusion Evaluation of the Atellica IM TnIH assay using the Atellica CI 1900 Analyzer demonstrated reproducible assay precision, sensitive detection capabilities, and equivalent performance compared to the same assay on the Atellica IM Analyzer. This evaluation shows that the Atellica IM TnIH assay on Atellica CI 1900 Analyzer meets the definition of a true high-sensitivity troponin I assay as defined by the International Federation of Clinical Chemistry (IFCC) Task Force on Clinical Applications of Cardiac Biomarkers. *The products/features mentioned here are not commercially available in all countries. Their future availability cannot be guaranteed.