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A Sensitive and Specific Quantitation Method for Determination of Serum Cardiac Myosin Binding Protein-C by Electrochemiluminescence Immunoassay
Published on: August 8, 2013
Diagnostic marker cooperative study for the diagnosis of myocardial infarction
J Zimmerman1, R Fromm, D Meyer
1General Medicine, Section of Cardiology, Baylor College of Medicine, Houston, TX, USA.
Insights
Diagnosing chest pain is challenging. Creatine kinase-MB (CK-MB) subforms and myoglobin are most sensitive for early detection, while CK-MB activity and troponin I are best for late diagnosis.
Area of Science:
- Cardiology
- Clinical Diagnostics
- Biomarker Research
Background:
- Chest pain is a common emergency department complaint, with myocardial infarction (MI) present in only 10-15% of cases.
- Current diagnostic markers for MI lack sufficient sensitivity and specificity, leading to treatment delays and unnecessary hospital admissions.
- Comparative data on novel cardiac biomarkers are scarce, yet utilizing all available markers is impractical and costly.
Purpose of the Study:
- To compare the diagnostic performance of various cardiac biomarkers for chest pain evaluation.
- To determine the sensitivity and specificity of creatine kinase-MB (CK-MB) subforms, myoglobin, total CK-MB, troponin T, and troponin I.
- To assess the utility of these markers in identifying myocardial infarction and unstable angina.
Main Methods:
- Prospective, multicenter, double-blind study enrolling 955 patients with chest pain.
- Serial sampling of biomarkers (CK-MB subforms, myoglobin, total CK-MB, troponin T, troponin I) for up to 24 hours.
- Analysis of diagnostic sensitivity, specificity, and marker elevation frequency in patients with unstable angina.
Main Results:
- CK-MB subforms demonstrated the highest sensitivity (91%) and specificity (89%) within 6 hours of symptom onset.
- Myoglobin was also highly sensitive and specific in early diagnosis (78% and 89%).
- For late diagnosis (10-18 hours), total CK-MB activity (96% sensitivity, 98% specificity) and troponin I (96% sensitivity, 93% specificity) showed superior performance.
Conclusions:
- The CK-MB subform assay, alone or combined with troponin, can reliably triage chest pain patients.
- This approach has the potential to improve patient therapy and reduce healthcare costs.
- Early and accurate diagnosis of cardiac events is crucial for effective management.
Background:
Millions of patients present annually with chest pain, but only 10% to 15% have myocardial infarction. Lack of diagnostic sensitivity and specificity of clinical and conventional markers prevents or delays treatment and leads to unnecessary costly admissions. Comparative data are lacking on the new markers, yet using all of them is inappropriate and expensive.
Methods And Results:
The Diagnostic Marker Cooperative Study was a prospective, multicenter, double-blind study with consecutive enrollment of patients with chest pain presenting to the emergency department. Diagnostic sensitivity and specificity and frequency of increase in patients with unstable angina were determined for creatine kinase-MB (CK-MB) subforms, myoglobin, total CK-MB (activity and mass), and troponin T and I on the basis of frequent serial sampling for =24 hours. Of 955 patients with chest pain, 119 (12.5%) had infarction identified by use of CK-MB mass, and 203 (21%) had unstable angina. CK-MB subforms were most sensitive and specific (91% and 89%) within 6 hours of onset, followed by myoglobin (78% and 89%). For late diagnosis, total CK-MB activity (derived from subforms) was the most sensitive and specific (96% and 98%) at 10 hours from onset, followed by troponin I (96% and 93%), but not until 18 hours, and troponin T (87% and 93% at 10 hours). In unstable angina, CK-MB subforms were increased in 29.5%, myoglobin in 23.7%, troponin I in 19.7%, and troponin T in 14.8%. All markers were increased in 99 patients. With each marker as the diagnostic standard, CK-MB subforms and myoglobin remained the most sensitive for early diagnosis.
Conclusions:
The CK-MB subform assay alone or in combination with a troponin reliably triages patients with chest pain and should lead to improved therapy and reduced cost.
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