Diagnostic accuracy of a bedside qualitative immunochromatographic test for acute myocardial infarction
1Department of Anesthesia and Critical Care, King Abdulaziz University, King Abdulaziz University Hospital, Jeddah, Saudi Arabia. jalhashemi@kau.edu.sa
Insights
CardioDetect, a point-of-care test, reliably diagnoses acute myocardial infarction within 12 hours using heart-type fatty acid-binding protein. This bedside test shows high sensitivity and specificity in emergency departments.
Area of Science:
- Cardiology
- Biomarker Detection
- Point-of-Care Diagnostics
Background:
- Early diagnosis of acute myocardial infarction (AMI) is critical for patient outcomes.
- Traditional diagnostic methods may have limitations in rapid assessment in emergency settings.
- Heart-type fatty acid-binding protein (H-FABP) is an emerging biomarker for cardiac injury.
Purpose of the Study:
- To evaluate the diagnostic efficacy of the CardioDetect bedside immunochromatographic test.
- To assess CardioDetect's ability to identify human heart-type fatty acid-binding protein in whole blood for AMI diagnosis.
- To compare CardioDetect's performance against established cardiac biomarkers like troponin I (TnI) and creatine kinase (CK).
Main Methods:
- Sixty-four patients presenting with chest pain underwent the CardioDetect test.
- Serial serum troponin I (TnI) and creatine kinase (CK) levels were determined.
- CardioDetect results were interpreted by blinded observers; AMI diagnosis was made by a blinded physician. Diagnostic accuracy metrics and reliability were assessed.
Main Results:
- Within 4 hours of chest pain onset, CardioDetect demonstrated 62.5% sensitivity and 100% specificity, outperforming TnI and CK.
- Between 4 and 12 hours, CardioDetect and TnI achieved 100% sensitivity, while CK showed 85.7%.
- High intraobserver agreement (kappa >0.80) and interobserver reliability (intraclass correlation coefficient >0.90) were observed for CardioDetect.
Conclusions:
- CardioDetect is a reliable point-of-care test for the early diagnosis of acute myocardial infarction.
- The test is effective for rapid AMI detection within the first 12 hours in the emergency department.
- CardioDetect offers a valuable bedside tool for timely cardiac assessment.
Objective:
To evaluate the diagnostic efficacy of a bedside immunochromatographic test (CardioDetect) that identifies human heart-type fatty acid-binding protein in whole blood.
Methods:
Sixty-four patients with chest pain had CardioDetect test performed together with serial determination of serum troponin I (TnI) and creatine kinase (CK). CardioDetect results were interpreted twice, 24 hours apart, by 3 independent observers who were blinded to patients' clinical and laboratory data. Acute myocardial infarction was diagnosed by a physician blinded to the results of the CardioDetect test. Sensitivity, specificity, positive and negative predictive values, diagnostic accuracy, and receiver operating characteristic curves were determined for all tests at 4 predefined times. Intraobserver and interobserver reliabilities were determined.
Results:
At less than 4 hours after chest pain, CardioDetect had a sensitivity and specificity of 62.5% and 100% compared with 50% and 80% for TnI and 37.5% and 80% for CK, respectively. At more than 4 hours but 12 hours or less in duration, the sensitivity of CardioDetect and TnI was 100%, whereas that of CK was 85.7%. Intraobserver agreement and interobserver reliability were high for CardioDetect (kappa >0.80 [P < .0001] and intraclass correlation coefficient, >0.90, respectively).
Conclusion:
CardioDetect was a reliable point-of-care test for the early diagnosis (<12 hours) of acute myocardial infarction in the ED.
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