Key result
CK-MB mass assay outperforms activity assay for early MI detection, reaching PPV over ~90% at 4 hours.
Why the study?
The comparative analytical and clinical performance of the Tandem Icon QSR CK-MB enzyme-immunoassay and a creatine kinase-MB immunoinhibition method in suspected acute myocardial infarction required evaluation.
Observational (n=38)
No
Answers are grounded in this paper and cite their sources.
May support mass assay for early AMI diagnosis at 4 hours; leaves open validation versus modern troponin protocols.
In a time study we compared the analytical and clinical performance of the Tandem Icon QSR CK-MB enzyme-immunoassay (Hybritech) (creatine kinase-MB) and a creatine kinase-MB immunoinhibition method (Boehringer Mannheim GmbH) (creatine kinase-B). Two hundred and ninety-nine serum samples from 38 patients suspected of acute myocardial infarction were collected at regular intervals during 48 hours. Twenty-nine patients were diagnosed as having acute myocardial infarction, of whom 19 received thrombolytic therapy. Although highly correlated, the large scatter around the regression line at low values indicated a different clinical performance of the two methods. We evaluated and compared test performance at different decision levels by means of frequency distributions and predictive values of positive and negative results. For early diagnosis of acute myocardial infarction (4 hours after onset of pain) the Hybritech creatine kinase-MB method gives acceptable predictive values. In thrombolytic treated acute myocardial infarction patients, the peak creatine kinase-MB and creatine kinase-B concentrations were reached after 13.0 h and 13.6 h after the onset of pain, compared with 19.8 h and 17.8 h for patients without thrombolytic therapy.
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Schiøler et al. (1992) conducted an observational in Suspected acute myocardial infarction (n=38). Tandem Icon QSR CK-MB enzyme-immunoassay (mass concentration) vs. Creatine kinase-MB immunoinhibition assay (catalytic activity) was evaluated on Duration of positive test results in AMI patients not receiving thrombolytic therapy (decision limit 9 μg/l vs 20 U/l) (p=<0.01). The Hybritech CK-MB mass assay achieved a positive predictive value >0.9 and negative predictive value >0.75 at 4 hours post-pain onset, outperforming the immunoinhibition activity assay.
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