Evaluation of a sandwich enzyme-linked immunosorbent assay for the measurement of serum heart fatty acid-binding protein.

BACKGROUND: We evaluated the sandwich enzyme-linked immunosorbent assay (ELISA) MARKIT-M for the determination of heart fatty-acid-binding protein (H-FABP). RESULTS AND CONCLUSIONS: The between-run coefficient of variation of this assay was <3.9 and it showed good correlation with a previously established ELISA method. The upper reference limit in 30 healthy individuals was 6.1 microg/L. Admission serum H-FABP was evaluated against myoglobin in 41 patients with suspected myocardial infarction (onset of symptoms < or = 5 h). H-FABP showed the same diagnostic efficiency as myoglobin [area (standard error) under the receiver operating characteristic curve: 0.798 (0.079) for H-FABP, 0.771 (0.085) for myoglobin, P = 0.55]. However, using the upper reference limit as decision cut-off, the sensitivity for H-FABP [91%; 95% confidence interval (CI): 76-98%] was significantly (P = 0.019) higher than that of myoglobin (65%; 95% CI: 47-80%).