Clinical assessment of specific enzyme immunoassay for the human cardiac myosin light chain II (MLC II) with use of monoclonal antibodies

A highly specific enzyme-linked “sandwich” immunoassay was developed for determining cardiac myosin light chain II (MLC II) in serum by using an anticardiac MLC II monoclonal antibody and a solid phase consisting of glass rods coated with another monoclonal antibody. We can detect as little as 0.2 ng of cardiac MLC II per assay. The measurable range of cardiac MLC II concentration in serum is 1 to 30 μg/L. The assay demonstrated no cross-reactivity with a skeletal muscle MLC within the measurable range. The mean coefficients of variation were 6.1% within assay and 5.1% between assay. The concentration of cardiac MLC II in sera from healthy subjects ranged from 0 to 4.0 μg/L (mean 0.75 μg/L and median 0 μg/L). The concentrations of cardiac MLC II in serum of patients with skeletal muscle disease due to various causes ( n = 15) and patients with effort angina ( n = 25), in general, were not significantly elevated above normal. In all patients with myocardial infarction, the concentrations of cardiac MLC II were over 4.0 μg/L at 12 h after onset. The mean (± 1 SD) peak concentration of cardiac MLC II was 16.2 (± 4.4) μg/L at 90 h (mean) after onset. On the 5th day, the cardiac MLC II concentrations in all patients with myocardial infarction were significantly elevated above normal; none showed abnormal MB-creatine kinase (CK-MB) activity at this time. Thus, the measurement of cardiac MLC II concentration in serum may be useful to provide a specific and sensitive diagnosis of myocardial necrosis at any time period following myocardial infarction.