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

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 usin...

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Published in:	The American heart journal Vol. 255; pp. 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:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-01-2023 Elsevier Limited
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 eGFR LoD CI CAD ROC ECG IQR AUC LoQ CV ESC MACE NPV PPV hs-cTn cTn MI LoB ED
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Summary:	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 <9ng/L at presentation (if chest pain onset >3h) or <9ng/L and 0h-1h-change <5ng/L, and for rule-in ≥160ng/L at presentation or 0h-1h-change ≥100ng/L. In the validation cohort (n = 345), these cut-offs ruled-out 56% of patients (negative predictive value 99.5% (95%CI, 97.1-99.9), sensitivity 97.8% (95%CI, 88.7-99.6)), and ruled-in 9% (positive predictive value 83.3% (95%CI, 66.4-92.7), specificity 98.3% (95%CI, 96.1-99.3)). Secondary analyses using adjudication based on hs-cTnT measurements confirmed the findings. The overall performance of the hs-cTnI-EXL was comparable to best-validated hs-cTnT/I assays and an assay-specific 0/1h-algorithm safely rules out and accurately rules in acute MI. ClinicalTrials.gov number, NCT00470587 [Display omitted]
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0002-8703 1097-6744
DOI:	10.1016/j.ahj.2022.10.007