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

Clin Biochem. 2007 Nov;40(16-17):1245-51. doi: 10.1016/j.clinbiochem.2007.07.018. Epub 2007 Aug 10.

Abstract

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.

MeSH terms

  • Biomarkers / analysis*
  • Carbonic Anhydrase III / analysis
  • Creatine Kinase, MB Form / analysis
  • Humans
  • Myocardial Infarction / diagnosis
  • Myocardial Infarction / metabolism
  • Myocardium / metabolism*
  • Myoglobin / analysis
  • Protein Array Analysis / methods*
  • ROC Curve
  • Sensitivity and Specificity
  • Troponin I / analysis

Substances

  • Biomarkers
  • Myoglobin
  • Troponin I
  • Creatine Kinase, MB Form
  • Carbonic Anhydrase III