Abstract

BACKGROUND: This prospective, two-centre study derived and validated predictive algorithms for the Siemens Atellica IM high-sensitivity cardiac troponin I (hs-cTnI) assay in the emergency department (ED). METHODS: Algorithms for predicting 30-day myocardial infarction type 1 and 2 (MI) and death or non-ST-elevation myocardial infarction (NSTEMI, type 1 and 2) at index admission were developed from a derivation cohort of 1896 patients and validated using a synthetic dataset with nearly 1 million patient cases. Performance was compared to the European Society of Cardiology algorithms for hs-cTnT (Roche Diagnostics) and hs-cTnI (Abbott Diagnostics). RESULTS: An admission hs-cTnI concentration < 5 ng/L had a negative predictive value (NPV) and sensitivity for 30-day MI or death of 99.5 - 99.7 and 98.1- 98.8%, respectively, in the derivation cohort and validation dataset. The NPV and sensitivity was ≥99.7% and ≥98.8% for ruling out index NSTEMI. A 0-1-hour algorithm with baseline hs-cTnI concentration < 10 ng/L and Δ change < 3 ng/L had NPV of ≥99.5% and sensitivity ≥97.3% for predicting 30-day MI or death, and a ≥99.5% sensitivity and NPV for index NSTEMI. Rule-in algorithms of either 0-hour hs-cTnI ≥ 120 ng/L or 0-1 h Δ change ≥ 12 ng/L had positive predictive value (PPV) ≥ 73% and specificity >96% for 30-day MI or death and index NSTEMI. The results were comparable to established hs-cTn algorithms. CONCLUSIONS: This study presents Siemens Atellica hs-cTnI algorithms for diagnosis and risk-prediction in the ED with performance comparable to established hs-cTnT (Roche) and hs-cTnI (Abbott) algorithms.