Diagnostic discrimination of a novel high-sensitivity cardiac troponin I assay and derivation/validation of an assay-specific 0/1h-algorithm

• Published in: The American heart journal 2023-01, Vol.255, p.58-70
• Main Authors: Koechlin, Luca, Boeddinghaus, Jasper, Lopez-Ayala, Pedro, Nestelberger, Thomas, Wussler, Desiree, Mais, Felix, Twerenbold, Raphael, Zimmermann, Tobias, Wildi, Karin, Köppen, Anne Marie, Miró, Òscar, Martin-Sanchez, F. Javier, Kawecki, Damian, Geigy, Nicolas, Keller, Dagmar I., Christ, Michael, Buser, Andreas, Giménez, Maria Rubini, Bernasconi, Luca, Hammerer-Lercher, Angelika, Mueller, Christian, de Lavallaz, Jeanne du Fay, Walter, Joan Elias, Freese, Michael, Puelacher, Christian, Strebel, Ivo, Rentsch, Katharina, Mitrovic, Sandra, Gualandro, Danielle M., Schaerli, Nicolas, Sanchez, Ana Yufera, Okamura, Bernhard, Shrestha, Samyut, López, Beatriz, Martinez-Nadal, Gemma, Adrada, Esther Rodriguez, Parenica, Jiri, von Eckardstein, Arnold, Morawiec, Beata, Muzyk, Piotr
• Format: Article
• Language: English
• Subjects: Algorithms; Angina pectoris; Architects; Assaying; Biomarkers; Calcium-binding protein; Cardiac stress tests; Chest; Creatinine; Derivation; Diagnostic systems; Emergency medical care; Emergency medical services; Heart; Heart attacks; Humans; Laboratories; Medical diagnosis; Myocardial infarction; Myocardial Infarction - diagnosis; Pain; Patients; Plasma; Prospective Studies; ROC Curve; Secondary analysis; Troponin; Troponin I; Troponin T
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2022.10.007

We aimed to assess the diagnostic utility of the Dimension EXL LOCI High-Sensitivity Troponin I (hs-cTnI-EXL) assay. This multicenter study included patients with chest discomfort presenting to the emergency department. Diagnoses were centrally and independently adjudicated by two cardiologists using all available clinical information. Adjudication was performed twice including serial measurements of high-sensitivity cardiac troponin (hs-cTn) I-Architect (primary analysis) and serial measurements of hs-cTnT-Elecsys (secondary analysis) in addition to the clinically used (hs)-cTn. The primary objective was to assess and compare the discriminatory performance of hs-cTnI-EXL, hs-cTnI-Architect and hs-cTnT-Elecsys for acute myocardial infarction (MI). Furthermore, we derived and validated a hs-cTnI-EXL-specific 0/1h-algorithm. Adjudicated MI was the diagnosis in 204/1454 (14%) patients. The area under the receiver operating characteristics curve for hs-cTnI-EXL was 0.94 (95%CI, 0.93-0.96), and comparable to hs-cTnI-Architect (0.95; 95%CI, 0.93-0.96) and hs-cTnT-Elecsys (0.93; 95%CI, 0.91-0.95). In the derivation cohort (n = 813), optimal criteria for rule-out of MI were 3h) or