Analytical and clinical performance of a fully automated cardiac multi-markers strategy based on protein biochip microarray technology.
OBJECTIVE
The analytical and clinical performance of the Evidence Cardiac Panel were evaluated.


METHODS
The Evidence Cardiac Panel, an automated protein biochip microarray system, allows the simultaneous determination of creatine kinase MB (CK-MB), myoglobin (MYO), glycogen phosphorylase BB (GPBB), heart-type fatty acid-binding protein (H-FABP), carbonic anhydrase III (CA III), cardiac troponin I (cTnI). Precision: 3 levels of quality control (QC) and 2 in house pools (P) were assayed. Method comparison: MYO and cTnI concentrations measured on Evidence (E) and on Dimension RxL (D) analyzers were compared. Clinical study: 132 non-consecutive patients admitted to the Emergency Department for chest pain were enrolled.


CONCLUSIONS
The between-day imprecision was CK-MB=6.80-10.08%; MYO=5.36-16.50%; GPBB=6.51-12.12%; H-FABP=6.26-12.63%; CA III=6.98-13.61%; cTnI=6.02-9.80%. Method comparison: E-MYO vs. D-MYO, Bias=-29.22, 95% CI from -40.25 to -18.18; E-cTnI vs. D-cTnI, Bias=-2.75, 95% CI from -4.04 to -1.46. In patients studied (at discharge: AMI, acute myocardial infarction n=42; non-AMI, n=90) H-FABP showed the highest accuracy (ROC analysis, AUC=0.92) and "cTnI+H-FABP" the greatest diagnostic efficacy (89.4%) in AMI diagnosis.
Mion
Monica M
MM
Department of Laboratory Medicine, University-Hospital of Padova, Via Giustiniani 2, 35128 Padova, Italy.
Novello
Enrica
E
Altinier
Sara
S
Rocco
Stefano
S
Zaninotto
Martina
M
Plebani
Mario
M
D015415:Biomarkers / Q000032:analysis*; D024403:Carbonic Anhydrase III / Q000032:analysis; D052279:Creatine Kinase, MB Form / Q000032:analysis; D006801:Humans; D009203:Myocardial Infarction / Q000175:diagnosis / Q000378:metabolism; D009206:Myocardium / Q000378:metabolism*; D009211:Myoglobin / Q000032:analysis; D040081:Protein Array Analysis / Q000379:methods*; D012372:ROC Curve; D012680:Sensitivity and Specificity; D019210:Troponin I / Q000032:analysis
D015415:Biomarkers; D009211:Myoglobin; D019210:Troponin I; D052279:Creatine Kinase, MB Form; D024403:Carbonic Anhydrase III