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Diagnostic discrimination of a novel high-sensitivity cardiac troponin I assay and derivation/validation of an
Luca Koechlin1, Jasper Boeddinghaus2, Pedro Lopez-Ayala3
1Cardiovascular 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.
Insights
The Dimension EXL LOCI High-Sensitivity Troponin I (hs-cTnI-EXL) assay demonstrates diagnostic utility comparable to other leading assays for acute myocardial infarction (MI). An assay-specific algorithm effectively rules out and rules in MI, improving emergency department diagnostics.
Area of Science:
- Cardiology
- Clinical Diagnostics
- Biomarker Assays
Background:
- Assessing the diagnostic performance of novel high-sensitivity troponin assays is crucial for timely acute myocardial infarction (MI) diagnosis.
- The Dimension EXL LOCI High-Sensitivity Troponin I (hs-cTnI-EXL) assay's utility required evaluation against established methods.
Purpose of the Study:
- To evaluate the diagnostic accuracy of the hs-cTnI-EXL assay for acute myocardial infarction (MI).
- To compare the discriminatory performance of hs-cTnI-EXL with hs-cTnI-Architect and hs-cTnT-Elecsys assays.
- To derive and validate a hs-cTnI-EXL-specific 0/1-hour algorithm for MI rule-out and rule-in.
Main Methods:
- Multicenter study involving patients with chest discomfort in the emergency department.
- Central adjudication of diagnoses by cardiologists, including serial measurements of hs-cTnI-Architect and hs-cTnT-Elecsys.
- Receiver operating characteristic (ROC) curve analysis to assess discriminatory performance.
Main Results:
- The hs-cTnI-EXL assay showed an area under the ROC curve of 0.94, comparable to hs-cTnI-Architect (0.95) and hs-cTnT-Elecsys (0.93).
- A derived 0/1-hour algorithm in the validation cohort achieved 97.8% sensitivity and 98.3% specificity for ruling out and ruling in MI, respectively.
- The algorithm safely ruled out MI in 56% of patients with a negative predictive value of 99.5%.
Conclusions:
- The hs-cTnI-EXL assay exhibits diagnostic performance comparable to existing high-sensitivity troponin assays.
- An assay-specific 0/1-hour algorithm provides a safe and accurate method for ruling out and ruling in acute MI.
- This assay and algorithm can aid in efficient and accurate MI diagnosis in emergency settings.
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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