ELECTROCHEMICAL BIOSENSOR OF CARDIAC MARKERS

建立了一种新型免疫层析电化学生物传感器(IEB)，用于同时测定肌钙蛋白-I、肌红蛋白和肌酸肌酸激酶同工酶(CK-MB)。肌钙蛋白-I、肌红蛋白和CK-MB被认为是诊断心肌梗死的重要指标。这种使用电化学检测器的生物传感器将避免当前免疫分析中的光学干扰，并将提供更高的准确度和灵敏度来快速定量分析对象。与现有的肌红蛋白定量方法相比，该方法具有灵敏度高、重现性好、快速、使用方便等优点。我们建议进一步优化这一同时定量上述心脏生物标志物的新方法，并开发一种便携式生物传感器用于医疗保健。提出的生物传感器将由免疫层析试条和电化学检测器组成，免疫层析试条产生这些心脏标记物与不同金属离子标记的特定抗体的免疫络合物，电化学检测器定量这些金属离子在络合物中的数量。将仔细开发IEB的设计，并将评估和优化测试条中电极对金属离子的同时定量。这种生物传感器将为正确的临床决策提供必要的信息，从而极大地提高冠状动脉护理的质量。拟议的商业应用：在美国，每年大约进行1600万次心脏检查。迫切需要一种快速、高特异性、高灵敏度、临床准确度高的方法来同时定量检测冠心病患者的心脏标志物。所提出的免疫层析电化学生物传感器有望在急诊室或冠心病监护病房提供心肌梗死诊断的这些特征。这种生物传感器将提供低成本、高效率、临床准确和操作简单的方法，无需技术培训，因此将在商业应用中具有更大的潜力。

Development of a novel immunochromatographic electrochemical biosensor(IEB) is proposed for simultaneous quantitation of Troponin-I, Myoglobin and CK-MB, which have been reported to be important indexes in the diagnosis of myocardial infraction. Such biosensor using electrochemical detectors will avoid optical interference in the current immunoassays, and will provide more accuracy and sensitivity to rapidly quantify analytes. Our preliminary results using the proposed methodology for quantitation of myoglobin demonstrated several advantages over the current existed method such as high sensitivity, reproducibility, rapidity and convenience in use. We propose to further optimize this novel method for simultaneous quantitation of the above mentioned cardiac bio-markers, and develop a portable biosensor in point-of-care application. The proposed biosensor will consist of an immunochromatographic strip which produces immuno-complexes of these cardiac markers with their specific antibodies labeled with different metal ions and an electrochemical detector which quantifies the amounts of these metal ions in the complex. Design of the IEB will be carefully developed, and simultaneous quantitation of metal ions by the electrode in the test strips will also be evaluated and optimized. Such biosensor will provide essential information for proper clinical decision, and thus greatly improve the quality of coronary care. PROPOSED COMMERCIAL APPLICATIONS: About 16 million cardiac examinations were conducted annually in the United States. A method with rapidity, high specificity and sensitivity, clinical accuracy is urgent to be developed for simultaneous quantitation of the cardiac markers in coronary care. The proposed immunochromatographic electrochemical biosensor is expected to provide these characteristics of myocardial infarction diagnosis at emergency room or coronary care units. Such biosensor will provide a low cost, highly efficient, clinically accurate and simple operation without technical training, and thus will have additional potential in commercial applications.