Analytical and clinical performance of a fully automated cardiac multi-markers strategy based on protein biochip microarray technology.

Objectives: The analytical and clinical performance of the Evidence (R) Cardiac Panel were evaluated. Design and methods: The Evidence (R) Cardiac Panel, an automated protein biochip microarray system, allows the simultaneous determination of creatine kinase MB (CK-MB), myoglobin (MYO), glycogen phosphorylase 1313 (GPBB), heart-type fatty acid-binding protein (H-FABP), carbonic anhydrase III (CA III), cardiac troponin I (cTnI). Precision: 3 levels of quality control (QQ and 2 in house pools (P) were assayed. Method comparison: MYO and cTnI concentrations measured on Evidence (R) (E) and on Dimension (R) RxL (D) analyzers were compared. Clinical study: 132 non-consecutive patients admitted to the Emergency Department for chest pain were enrolled. Results and 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 "cTnl+H-FABP" the greatest diagnostic efficacy (89.4%) in AMI diagnosis. (C) 2007 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.