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Abstract
Objectives : An analytical and clinical evaluation of cTnI on the ImmuliteTurbo system with 15 min assay time compared to 45 min with the original Immulite assay is presented. Methods and Design : Detection limit, functional sensitivity, AMI decision limit, assay linearity, influence of sample material (serum, heparin, citrate and EDTA plasma), interference, analytical and clinical method comparison studies were performed. Results : Functional sensitivity (at CV 20%) was 0.35 compared to 0.23 mug/L for the original assay. AMI decision limit (99th percentile of a reference control group) was 0.48 mug/L for both assays. In patients with acute coronary syndromes, chronic renal failure or pulmonary embolism the assays showed concordant results in 87.2-96.5%. Differing results were only found around the cut-off level and were attributed to assay imprecision. Conclusion : The new assay is sensitive for the determination of cTnI, shows comparable results to the original assay version and is easy to perform within 15 min.