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Multicenter Study
. 2025 Mar 22;14(3):155-168.
doi: 10.1093/ehjacc/zuaf017.

Clinical derivation and data simulated validation of rule-out and rule-in algorithms for the Siemens Atellica IM high-sensitivity cardiac troponin I assay

Ingar Ziad Restan  1 , Ole-Thomas Steiro  2 , John W Pickering  3   4 , Hilde L Tjora  5 , Jørund Langørgen  2 , Torbjørn Omland  6   7 , Paul Collinson  8   9 , Rune Bjørneklett  5   10 , Kjell Vikenes  2   11 , Trude Steinsvik  12 , Øyvind Skadberg  13 , Øistein R Mjelva  1 , Alf Inge Larsen  1   11 , Vernon V S Bonarjee  1 , Kristin M Aakre  2   11   14
Affiliations
Multicenter Study

Clinical derivation and data simulated validation of rule-out and rule-in algorithms for the Siemens Atellica IM high-sensitivity cardiac troponin I assay

Ingar Ziad Restan et al. Eur Heart J Acute Cardiovasc Care. .

Abstract

Aims: 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 and results: Algorithms for predicting 30-day myocardial infarction (MI) Types 1 and 2 and death or non-ST-elevation MI (NSTEMI, Types 1 and 2) at index admission were developed from a derivation cohort of 1896 patients and validated using a synthetic data set with nearly 1 million patient cases. Performance was compared with the European Society of Cardiology algorithms for hs-cTnT (Roche Diagnostics) and hs-cTnI (Abbott Diagnostics). 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 data set. The NPV and sensitivity were ≥99.7% and ≥98.8% for ruling out index NSTEMI. A 0- to 1-h 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-h hs-cTnI ≥ 120 ng/L or 0- to 1-h Δ change ≥ 12 ng/L had positive predictive value ≥ 73% and specificity > 96% for 30-day MI or death and index NSTEMI. The results were comparable with established hs-cTn algorithms.

Conclusion: This study presents Siemens Atellica hs-cTnI algorithms for diagnosis and risk prediction in the ED with performance comparable with established hs-cTnT (Roche) and hs-cTnI (Abbott) algorithms.

Keywords: Acute coronary syndrome; Death; High-sensitivity cardiac troponin; Myocardial infarction; NSTEMI; Non-ST-elevation myocardial infarction; Siemens Atellica IM hs-cTnI; Simulated patients; Synthetic validation.

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Conflict of interest statement

Conflict of interest: K.M.A. has served on an advisory board for Roche Diagnostics, Siemens Healthineers, and SpinChip and received consultant honoraria from CardiNor, lecturing honorarium from Siemens Healthineers, Mindray, and Snibe Diagnostics, and research grants from Siemens Healthineers and Roche Diagnostics. K.M.A. is an associate editor of Clinical Biochemistry and Chair of the IFCC Committee of Clinical Application of Cardiac Biomarkers. J.W.P. has undertaken statistical consultancy for Siemens Healthineers, Radiometer, QuidelOrtho, Abbott Point of Care, Roche, and Upstream Medical Technologies. T.O. has received research support from Abbott Laboratories, ChromaDex, Novartis, and Roche Diagnostics via Akershus University Hospital and consultant or speaker honoraria from Abbott Laboratories Diagnostics, Bayer Healthcare, CardiNor, and Roche Diagnostics. T.O. is a board member and owns stock in CardiNor and is on a patent (Roche, patent application numbers EP21740587 and EP20186620). Ø.S. has received lecture fees from Abbott Diagnostics. Ø.R.M. has received payment from Pfizer in relation to work as facilitator at a POCUS course (emergency medicine). There are at present no known other possible conflicts of interest.

Figures

Graphical Abstract
Graphical Abstract
*Patients who both had MI and died are counted in both groups of the figure only for illustrative purposes, though in the statistical analysis each patient could at most count for one positive endpoint.
Figure 1
Figure 1
Flow chart overview of the analytical and methodological process for derivation of novel algorithms, generation and simulation of predictive variables, and synthetic validation. *Patients who both had MI and died are counted in both groups of the figure only for illustrative purposes, but in the statistical analysis each patient could at most count for one positive endpoint. CABG, coronary artery bypasss graft; GFR, glomerular filtration rate; MI, myocardial infarction; NSTEMI, non-ST-elevation myocardial infarction; PCI, percutaneous coronary intervention.
Figure 2
Figure 2
Cumulative percentage of patients cumulative percentage of patients who had baseline high-sensitivity cardiac troponin I (Siemens) concentrations below certain cut-off (0–20 ng/L) in all patients (A, B) and in the subgroup of patients who died or had myocardial infarction within 30 days of inclusion (C, D) for both derivation and validation cohort. hs-cTnI, high-sensitivity cardiac troponin I; MI, myocardial infarction.
Figure 3
Figure 3
Negative predictive value, sensitivity, and specificity Negative predictive value, sensitivity, and specificity for 30-day myocardial infarction or death by baseline high-sensitivity cardiac troponin I (Siemens) concentrations below certain cut-offs (0–20 ng/L) in the derivation and validation cohort. Dashed line at 99.5% for NPV plots, 97% for sensitivity plots and 50% for specificity plots. hs-cTnI, high-sensitivity cardiac troponin I; MI, myocardial infarction; NPV, negative predictive value.
See this image and copyright information in PMC

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