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® Cardiac Panel were evaluated.Design and 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.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 “cTnI + H-FABP” the greatest diagnostic efficacy (89.4%) in AMI diagnosis.