Reference values and biological determinants for cardiac myosin-binding protein C concentrations assessed with an enzyme-linked immunosorbent assay

Abstract

Background: Cardiac myosin-binding protein C (cMyC) is a novel cardio-specific biomarker of potential diagnostic and prognostic value for cardiovascular events. This study aims to determine reference values for cMyC and identify biological determinants of its concentration. Methods: A population of 488 presumably healthy adults were enrolled to define biological determinants which affect cMyC concentrations in serum. Concentrations of cMyC were assessed using enzyme-linked immunosorbent assays from commercially available kits. Eligibility for inclusion in this study evaluated all subjects' anthropometric, demographic and laboratory measurements. After applying strict inclusion criteria, a reference population (n=150) was defined and used to determine reference values. Reference values were derived using a robust method. Results: The distribution of cMyC concentrations in the reference population was non-parametric and right-skewed, with only 2 subjects having concentrations lower than the detection limit. Female gender was the only independent determinant of higher cMyC concentrations in the presumably healthy population. There were no significant relationships between cMyC and other investigated parameters in the reference population. The overall upper reference limit (URL) set at the 99th percentile for cMyC concentration was 42.29 ng/mL and did not differ between women and men (42.52 vs 42.35 ng/mL). Conclusion: This study successfully established reference values for the assessed cMyC assay and investigated its biological determinants. Despite the impact of female gender on cMyC concentrations in the presumably healthy population, we did not detect sex-dependent differences in the cMyC 99th URL and therefore recommend using a single method-specific 99th URL for adults.