Diagnostic discrimination of a novel high-sensitivity cardiac troponin I assay and derivation/validation of an assay-specific 0/1h-algorithm
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Diagnostic discrimination of a novel high-sensitivity cardiac troponin I assay and derivation/validation of an assay-specific 0/1h-algorithm. / 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; APACE Investigators.
In: AM HEART J, Vol. 255, 01.2023, p. 58-70.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Diagnostic discrimination of a novel high-sensitivity cardiac troponin I assay and derivation/validation of an assay-specific 0/1h-algorithm
AU - Koechlin, Luca
AU - Boeddinghaus, Jasper
AU - Lopez-Ayala, Pedro
AU - Nestelberger, Thomas
AU - Wussler, Desiree
AU - Mais, Felix
AU - Twerenbold, Raphael
AU - Zimmermann, Tobias
AU - Wildi, Karin
AU - Köppen, Anne Marie
AU - Miró, Òscar
AU - Martin-Sanchez, F Javier
AU - Kawecki, Damian
AU - Geigy, Nicolas
AU - Keller, Dagmar I
AU - Christ, Michael
AU - Buser, Andreas
AU - Giménez, Maria Rubini
AU - Bernasconi, Luca
AU - Hammerer-Lercher, Angelika
AU - Mueller, Christian
AU - APACE Investigators
N1 - Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.
PY - 2023/1
Y1 - 2023/1
N2 - BACKGROUND: We aimed to assess the diagnostic utility of the Dimension EXL LOCI High-Sensitivity Troponin I (hs-cTnI-EXL) assay.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number, NCT00470587.
AB - BACKGROUND: We aimed to assess the diagnostic utility of the Dimension EXL LOCI High-Sensitivity Troponin I (hs-cTnI-EXL) assay.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number, NCT00470587.
KW - Humans
KW - Prospective Studies
KW - Biomarkers
KW - Troponin I
KW - ROC Curve
KW - Myocardial Infarction/diagnosis
KW - Troponin T
U2 - 10.1016/j.ahj.2022.10.007
DO - 10.1016/j.ahj.2022.10.007
M3 - SCORING: Journal article
C2 - 36243111
VL - 255
SP - 58
EP - 70
JO - AM HEART J
JF - AM HEART J
SN - 0002-8703
ER -
