Analytical and clinical evaluation of a new heart-type fatty acid-binding protein automated assay.
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.
Zaninotto
Martina
M
Department of Laboratory Medicine, University Hospital of Padova, Padova, Italy. martina.zaninotto@sanita.padova.it
Mion
Monica Maria
MM
Novello
Enrica
E
Altinier
Sara
S
Rocco
Stefano
S
Cacciavillani
Luisa
L
Perazzolo Marra
Martina
M
Iliceto
Sabino
S
Plebani
Mario
M
D000368:Aged; D015415:Biomarkers / Q000097:blood; D001774:Blood Chemical Analysis / Q000295:instrumentation / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation / Q000379:methods; D000074026:Fatty Acid Binding Protein 3; D050556:Fatty Acid-Binding Proteins / Q000097:blood*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000175:diagnosis*; D009211:Myoglobin / Q000097:blood; D040081:Protein Array Analysis / Q000295:instrumentation / Q000379:methods; D012372:ROC Curve; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D015415:Biomarkers; C493408:FABP3 protein, human; D000074026:Fatty Acid Binding Protein 3; D050556:Fatty Acid-Binding Proteins; D009211:Myoglobin