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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
L. Koechlin, J. Boeddinghaus, P. Lopez-Ayala, T. Nestelberger, D. Wussler, F. Mais, R. Twerenbold, T. Zimmermann, K. Wildi, AM. Köppen, Ò. Miró, FJ. Martin-Sanchez, D. Kawecki, N. Geigy, DI. Keller, M. Christ, A. Buser, MR. Giménez, L....
Language English Country United States
Document type Multicenter Study, Journal Article
NLK
ProQuest Central
from 2002-01-01 to 2 months ago
Nursing & Allied Health Database (ProQuest)
from 2002-01-01 to 2 months ago
Health & Medicine (ProQuest)
from 2002-01-01 to 2 months ago
Health Management Database (ProQuest)
from 2002-01-01 to 2 months ago
Public Health Database (ProQuest)
from 2002-01-01 to 2 months ago
- MeSH
- Biomarkers MeSH
- Myocardial Infarction * diagnosis MeSH
- Humans MeSH
- Prospective Studies MeSH
- ROC Curve MeSH
- Troponin I * MeSH
- Troponin T MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
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.
BHF University Centre for Cardiovascular Science University of Edinburgh Edinburgh UK
Critical Care Research Group and the University of Queensland Brisbane Queensland Australia
Department of Cardiac Surgery University Hospital Basel University of Basel Basel Basel Switzerland
Department of Cardiology Heart Center Leipzig University of Leipzig Leipzig Saxony Germany
Division of Internal Medicine University Hospital Basel University of Basel Basel Basel Switzerland
Emergency Department Hospital Clinic Barcelona Catalonia Spain
Emergency Department Kantonsspital Liestal Liestal Liestal Switzerland
Emergency Department Kantonsspital Luzern Luzern Luzern Switzerland
Emergency Department University Hospital Zurich Zurich Zurich Switzerland
GREAT network Basel Basel Switzerland
Institute of Laboratory Medicine County Hospital Aarau Aarau Aarau Switzerland
Servicio de Urgencias Hospital Clínico San Carlos Madrid Madrid Spain
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- $a Koechlin, Luca $u Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Basel, Switzerland; Department of Cardiac Surgery, University Hospital Basel, University of Basel, Basel, Basel, Switzerland; GREAT network, Basel, Basel, Switzerland. Electronic address: luca.koechlin@usb.ch
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- $a 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.
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