Analytical and clinical evaluation of a new heart-type fatty acid-binding protein automated assay

Clin Chem Lab Med. 2006;44(11):1383-5. doi: 10.1515/CCLM.2006.246.

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+/-16 years) 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 2.32-44.03 microg/L) and 9.03%-12.63% (range 11.85-65.13 microg/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 95 microg/L and 89.47% for Myo and 5.09 microg/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.

Publication types

  • Evaluation Study

MeSH terms

  • Aged
  • Biomarkers / blood
  • Blood Chemical Analysis / instrumentation
  • Blood Chemical Analysis / methods*
  • Enzyme-Linked Immunosorbent Assay / instrumentation
  • Enzyme-Linked Immunosorbent Assay / methods
  • Fatty Acid Binding Protein 3
  • Fatty Acid-Binding Proteins / blood*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / blood
  • Myocardial Infarction / diagnosis*
  • Myoglobin / blood
  • Protein Array Analysis / instrumentation
  • Protein Array Analysis / methods
  • ROC Curve
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Biomarkers
  • FABP3 protein, human
  • Fatty Acid Binding Protein 3
  • Fatty Acid-Binding Proteins
  • Myoglobin