Diagnostic validation of a novel high-sensitivity cardiac troponin T assay

AIMS: High-sensitivity cardiac troponin (hs-cTn) assays are integral to evaluating suspected myocardial infarction (MI). A recently developed hs-cTnT assay requires diagnostic and prognostic evaluation. METHODS AND RESULTS: Patients presenting to the emergency department with suspected non-ST-elevation MI were prospectively evaluated. Discrimination was tested using the area under the curve (AUC). Diagnostic performance was assessed with previously derived cut-off concentrations and ESC 0/1 h algorithm. Head-to-head comparisons between the new and established assays were performed. Prognostic performance of hs-cTnT for 1-year mortality and major adverse cardiac events (MACE) was analysed using adjusted Cox regression. In 1415 patients, mean age 64 years and 64.2% male, MI was diagnosed in 12.1%. The novel TnT hs Gen 6 assay demonstrated excellent discrimination with an AUC on admission of 0.87 (95% CI: 0.84, 0.90) and 0.91 (95% CI: 0.89, 0.93) after 1 h. Using a 0 h cut-off