Evaluation of the new ImmuliteTurbo cTnI assay and the original Immulite cTnI assay

Objectives: An analytical and clinical evaluation of cTnI on the ImmuliteTu rbo system with 15 min assay time compared to 45 min with the original Immu lite assay is presented. Methods and Design: Detection limit, functional se nsitivity, AMI decision limit. assay linearity, influence of sample materia l (serum, heparin, citrate and EDTA plasma). interference, analytical and c linical method comparison studies were performed. Results: Functional sensi tivity (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 r enal 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 sensitiv e for the determination of cTnI, shows comparable results to the original a ssay version and is easy to perform within 15 min.