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Diagnostic Evaluation of a High-Sensitivity Troponin I Point-of-Care Assay
Nils A Sörensen1,2, Johannes T Neumann3,2, Francisco Ojeda3
1Department of Cardiology, University Heart and Vascular Center Hamburg, Hamburg, Germany; n.soerensen@uke.de.
Insights
A new point-of-care high-sensitivity troponin I assay offers a safe and effective way to diagnose myocardial infarction. Its performance is comparable to lab-based assays, potentially speeding up emergency department decisions.
Area of Science:
- Cardiology
- Emergency Medicine
- Biomarker Diagnostics
Background:
- Emergency departments face increasing patient volumes with suspected myocardial infarction.
- Point-of-care (POC) troponin assays may expedite diagnosis and reduce facility burden.
- Evaluating the diagnostic performance of a novel POC high-sensitivity troponin I assay is crucial.
Purpose of the Study:
- To assess the diagnostic accuracy of a 0/1 hour algorithm using a POC high-sensitivity troponin I assay.
- To determine the safety and efficacy of this POC assay in a real-world emergency setting.
- To compare the POC assay's performance against established laboratory-based methods.
Main Methods:
- Prospective cohort study of patients with suspected myocardial infarction (July 2013 - July 2016).
- Development of a diagnostic algorithm using a POC high-sensitivity troponin I assay in 669 patients.
- Validation of the algorithm in an independent cohort of 610 patients.
Main Results:
- The 0/1 hour algorithm demonstrated a negative predictive value of 99.7% for ruling out myocardial infarction.
- 48.0% of patients were ruled out, and 14.6% were ruled in, with a positive predictive value of 86.5%.
- Diagnostic performance was highly comparable to laboratory-based high-sensitivity troponin assays.
Conclusions:
- The clinical implementation of a 0/1 hour algorithm with a POC high-sensitivity troponin I assay is safe.
- This POC assay provides diagnostic performance equivalent to traditional laboratory-based assays.
- The assay facilitates rapid decision-making for suspected myocardial infarction in emergency settings.
Background:
Increasing numbers of patients are presenting worldwide to emergency departments with suspected myocardial infarction. The use of point-of-care troponin assays might enable faster decision-making in this high-risk population and reduce the burden on emergency facilities. Here, we evaluate the diagnostic performance of a point-of-care high-sensitivity troponin I assay.
Methods:
We conducted a prospective cohort study including patients presenting to the emergency department with suspected myocardial infarction from July 2013 to July 2016. A diagnostic algorithm for a high-sensitivity troponin I point-of-care assay was developed in a derivation data set with 669 patients and validated in an additional 610 patients.
Results:
The derived 0/1 h algorithm for the point-of-care assay consisted of an admission troponin I <4 ng/L and a δ from 0 h to 1 h <3 ng/L for rule out and an admission troponin I ≥90 ng/L or a δ from 0 h to 1 h ≥20 ng/L for rule in of non-ST-elevation myocardial infarction. Application to the validation cohort showed a negative predictive value of 99.7% (95% CI, 98.1%-100.0%) and 48.0% of patients ruled out, whereas 14.6% were ruled in with a positive predictive value of 86.5% (95% CI, 77.6%-92.8%). The diagnostic performance of the point-of-care high-sensitivity assay was highly comparable to guideline-recommended use of a laboratory-based high-sensitivity troponin assay.
Conclusions:
The clinical application of a 0/1 h diagnostic algorithm based on a high-sensitivity troponin I point-of-care assay is safe, and diagnostic performance is comparable to a laboratory-based high-sensitivity troponin I assay.
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