Evaluation of an immunoradiometric assay specific for the CK-MB isoenzyme for detection of acute myocardial infarction.

Clinical evaluation of patient's symptoms, electrocardiographic changes and increased serum enzyme levels, specifically creatine kinase (CK)-MB by electrophoresis, are established as the primary diagnostic indicators for myocardial infarction (MI). Two hundred fifteen patients were evaluated in this study. Of these patients, 102 were admitted to the coronary care unit and 113 were admitted to the emergency room and screened for possible MI. The immunoradiometric assay used in this study was a double antibody "sandwich" technique, which utilizes antibody to the M and B monomers of the CK isoenzymes. This assay is specific for the CK-MB isoenzyme, which is present in increased levels in MI. The intraassay coefficients of variation for 30 samples were 11.7% (mean 4.1 equivalent units [EU]/liter) and 8.4% (mean 15.4 EU/liter) and the interassay coefficients of variation for 30 samples were 11.1% (mean 2.6 EU/liter) and 8.1% (mean 13.6 EU/liter). The diagnostic sensitivity, specificity and accuracy in this study was 100%, respectively. The CK-MB by the immunoradiometric assay was found to be significantly more accurate than electrophoresis and, therefore, a reliable and also technically simpler replacement for electrophoresis.