Mion Monica M, Novello Enrica, Altinier Sara, Rocco Stefano, Zaninotto Martina, Plebani Mario
Department of Laboratory Medicine, University-Hospital of Padova, Via Giustiniani 2, 35128 Padova, Italy.
Clin Biochem. 2007 Nov;40(16-17):1245-51. doi: 10.1016/j.clinbiochem.2007.07.018. Epub 2007 Aug 10.
The analytical and clinical performance of the Evidence Cardiac Panel were evaluated.
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.
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.
评估心脏证据检测板的分析性能和临床性能。
心脏证据检测板是一种自动化蛋白质生物芯片微阵列系统，可同时检测肌酸激酶同工酶MB（CK-MB）、肌红蛋白（MYO）、糖原磷酸化酶BB（GPBB）、心脏型脂肪酸结合蛋白（H-FABP）、碳酸酐酶III（CA III）、心肌肌钙蛋白I（cTnI）。精密度：检测3个水平的质量控制（QC）和2个内部样本池（P）。方法比较：比较在心脏证据检测板（E）和Dimension RxL分析仪（D）上测得的MYO和cTnI浓度。临床研究：纳入132例因胸痛入住急诊科的非连续患者。
日间不精密度为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%。方法比较：E-MYO与D-MYO相比，偏差=-29.22，95%置信区间为-40.25至-18.18；E-cTnI与D-cTnI相比，偏差=-2.75，95%置信区间为-4.04至-1.46。在研究的患者中（出院时：急性心肌梗死（AMI）患者n = 42；非AMI患者n = 90），H-FABP在AMI诊断中显示出最高的准确性（ROC分析，曲线下面积（AUC）= 0.92），“cTnI + H-FABP”具有最大的诊断效能（89.4%）。
