Di Serio Francesca, Amodio Gianfranco, Ruggieri Enzo, De Sario Rosalisa, Varraso Lucia, Antonelli Gianfranco, Pansini Nicola
Patologia Clinica I, University-Hospital of Bari, Piazza Giulio Cesare N. 11, Bari, Italy.
Clin Chim Acta. 2005 Jul 24;357(2):226-35. doi: 10.1016/j.cccn.2005.03.031.
Cardiac multimarker strategy is recommended by the IFCC, ESC and the ACC for an early risk stratification in non-ST-segment elevation (NSTE) ECG patients with chest pain. A new approach, based on protein biochip array technology, performs simultaneously: cTnI, CK-MB, myoglobin, CAIII, GFBB and FABP using a single chip.
We evaluated the analytical performance of the Randox-Evidence Investigator -biochip cardiac panel according to IFCC recommendations and NCCLS guidelines; a preliminary clinical evaluation was carried out on chest pain NSTE ECG patients, to evaluate the accuracy of the multimarker approach in an early diagnosis of AMI, related to the final diagnosis (ACC/ESC criteria).
Troponin, CK-MB and FABP methods provide reproducible within-run and between-day results (total % CVs from 5.9% to 9.7%), and myoglobin and CAIII methods showed the total % CVs from 16.4% to 25.8%. Our preliminary clinical data suggests that FABP had a better diagnostic performance (sensibility = 100%) than myoglobin (sensibility = 75%) to detect AMI in the first hours after the onset of the chest pain and myoglobin/CAIII ratio (specificity = 92.9%) improved the myoglobin specificity.
Cardiac markers have different diagnostic roles and, in this contest, biochip technology could be an interesting approach supporting clinical expectations.
国际临床化学与检验医学联合会（IFCC）、欧洲心脏病学会（ESC）和美国心脏病学会（ACC）推荐采用心脏多标志物策略对非ST段抬高（NSTE）胸痛心电图患者进行早期风险分层。一种基于蛋白质生物芯片阵列技术的新方法，可使用单个芯片同时检测肌钙蛋白I（cTnI）、肌酸激酶同工酶（CK-MB）、肌红蛋白、碳酸酐酶III（CAIII）、谷氨酸-草酰乙酸转氨酶（GFBB）和脂肪酸结合蛋白（FABP）。
我们根据IFCC的建议和美国国家临床实验室标准委员会（NCCLS）的指南，评估了兰多克斯证据调查者生物芯片心脏检测板的分析性能；对NSTE胸痛心电图患者进行了初步临床评估，以评估多标志物方法在急性心肌梗死（AMI）早期诊断中的准确性，并与最终诊断（ACC/ESC标准）相关。
肌钙蛋白、CK-MB和FABP方法在批内和批间均能提供可重复的结果（总变异系数百分比从5.9%到9.7%），而肌红蛋白和CAIII方法的总变异系数百分比为16.4%到25.8%。我们的初步临床数据表明，在胸痛发作后的最初几个小时内，FABP检测AMI的诊断性能（敏感性=100%）优于肌红蛋白（敏感性=75%），且肌红蛋白/CAIII比值（特异性=92.9%）提高了肌红蛋白的特异性。
心脏标志物具有不同的诊断作用，在这种情况下，生物芯片技术可能是一种符合临床预期的有趣方法。
