Evaluation of a new rapid quantitative immunoassay for serum myoglobin versus CK-MB for ruling out acute myocardial infarction in the emergency department.

Study Objective: To compare the predictive values of serum myoglobin and creatine kinase (CK)-MB for ruling out acute myocardial infarction in the emergency department.

Design: Prospective, observational study.

Setting: University teaching hospital.

Participants: One hundred eighty nine consecutive patients aged 30 years and older who presented within 12 hours from onset of chest discomfort, dyspnea, syncope, congestive heart failure, symptomatic dysrhythmia, pulmonary edema, or epigastric pain were entered into the study. Patients with trauma or renal failure were excluded.

Interventions: Standardized history and physical examination and blood sampling for serum myoglobin (S-Mgb) and CK-MB were done at the time of presentation (T0) and 1 hour later (T1).

Results: Using World Health Organization criteria, 22 acute myocardial infarction patients were identified. Mean time from symptom onset to presentation was 3.2 hours. S-Mgb was more sensitive than CK-MB at T0 and T1, 55% versus 23% (P < .05) and 73% versus 41% (P < .05), respectively. Respective specificities of S-Mgb versus CK-MB were 98% versus 99% (P = NS) at T0 and 97% versus 99% (P = NS) at T1. Negative predictive values of S-Mgb versus CK-MB were 94% versus 91% (P = NS) at T0 and 96% versus 93% (P = NS) at T1. The S-Mgb assay yielded quantitative results allowing the difference between the T0 and T1 values to be analyzed. A difference of 40 or more ng/mL between T0 and T1 was considered positive. When using a positive result in either the T0 or T1 value or a difference between the two values of 40 or more ng/mL, the sensitivity of S-Mgb was 91% (P < .05 versus CK-MB), the specificity was 96% (P = NS versus CK-MB), and the negative predictive value was 99% (95% confidence interval for S-Mgb, 97.0 to 100 versus CK-MB, 95% confidence interval, 88.9 to 96.6).

Conclusion: In the first hour of presentation to the ED, the rapid quantitative assay for S-Mgb was statistically more sensitive than CK-MB and had an excellent negative predictive value for ruling out acute myocardial infarction in patients with typical or atypical symptoms. Due to the relatively small sample size, we could not exclude the possibility that differences in specificity might become statistically significant (beta error) with a larger sample size of acute myocardial infarction patients.