1. Clinical derivation and data simulated validation of rule-out and rule-in algorithms for the Siemens Atellica IM high-sensitivity cardiac troponin I assay.
- Author
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Restan IZ, Steiro OT, Pickering JW, Tjora HL, Langørgen J, Omland T, Collinson P, Bjørneklett R, Vikenes K, Steinsvik T, Skadberg Ø, Mjelva ØR, Larsen AI, Bonarjee VVS, and Aakre KM
- 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., (© The Author(s) 2025. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2025
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