Analytical and clinical evaluation of a new heart-type fatty acid-binding protein automated assay
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Martina Zaninotto
Abstract
Background: The accurate and rapid recognition of myocardial injury in patients presenting in the emergency department (ED) with chest pain continues to be a clinical challenge. Heart-type fatty acid-binding protein (H-FABP) appears to be one of the best candidates among the new early cardiac markers studied.
Methods: We evaluated the analytical characteristics of a new quantitative and fully automated H-FABP assay (Randox Laboratories Ltd., Crumlin, UK) and compared its clinical performance with respect to the myoglobin (Myo) assay (Dade Behring, Milan, Italy). A precision study was carried out by testing three levels of quality control (QC) material and two in-house pool (P) samples. To test the accuracy of H-FABP determinations in plasma (lithium-heparin) samples, H-FABP concentrations measured in a set of matched sera and plasma samples were compared. A total of 77 non-consecutive patients (51 males and 26 females; 62±16years) who presented to the ED with chest pain suggesting myocardial ischemia were enrolled. The patients were classified into two groups (acute myocardial infarction, n=22; non-acute myocardial infarction, n=55) on the basis of the discharge diagnosis.
Results: The between-day imprecision for three levels of control material and serum pool samples was 6.26%–8.04% (range 2.32–44.03μg/L) and 9.03%–12.63% (range 11.85–65.13μg/L), respectively. In the serum vs. plasma study, bias was +0.178 (95% CI −0.033 to +0.389). The best cut-off and the associated diagnostic efficacy were 95μg/L and 89.47% for Myo and 5.09μg/L and 98.70% for H-FABP, respectively.
Conclusions: H-FABP determination in patients with ischemic symptoms may be a more reliable early indication of cardiac damage than myoglobin.
Clin Chem Lab Med 2006;44:1383–5.
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©2006 by Walter de Gruyter Berlin New York
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- MTRR 66A>G polymorphism in relation to congenital heart defects
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- Analytical validation of the new plasma calibrated Accu-Chek® Test Strips (Roche Diagnostics)
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