ANTIBODY MICROARRAY FOR DETECTION OF TUMOR MARKERS

描述(由申请人提供)： 这一第二阶段计划的目标是开发免疫传感微电极阵列，用于筛选血液、尿液和组织样本中的多种肿瘤标记物。这些阵列的设计使得它们可以对来自单个小体积样本的肿瘤标记物进行电化学同时多分析免疫分析(SMAI)。电化学SMAI代表了免疫分析方法学的重大进步，它很重要，因为它增加了测试吞吐量，降低了每次测试的成本，并提高了测试效率。这些阵列将增加肿瘤标记物在癌症诊断、治疗评估和分子图谱基础研究中的诊断价值，允许同时定量测量与同一类型癌症相关的多组标记物。目前，单一肿瘤标志物浓度的测量在诊断中的作用有限。这些阵列解决了现有蛋白质阵列方法的主要局限性，即通过使用亲水性的三维电极矩阵来固定蛋白质，从而关注固定在二维底物上的蛋白质的变性。该阵列还具有其他显著的优点，即高灵敏度，通过使用经济的电化学检测方法而不需要昂贵的光学成像设备，不受样品混浊、猝灭或吸收和荧光化合物的干扰的影响，并且使用简单且容易小型化到电路板级别的仪器，促进了用于超少量样品的经济型微量分析仪和方法的开发。 第一阶段计划证明了电化学SMAI在单个样本中检测两种不同肿瘤标志物的可行性。第二阶段计划的目的是通过优化电化学免疫传感器的制备和检测设计，将第一阶段阵列扩展到更多的免疫传感电极，以及开发用于同时检测和定量多个肿瘤标志物的原型阵列，来完善这项技术。第二阶段将侧重于开发一个强大、可靠和可重复使用的分析系统。

DESCRIPTION (provided by applicant): The goal of this Phase II program is the development of immunosensing microelectrode arrays for use in the screening of multiple tumor markers in blood, urine and tissue samples. The arrays are designed so that they perform electrochemical simultaneous multianalyte immunoassays (SMAI) for tumor markers from single, small volume samples. Electrochemical SMAI, which represents a major advance in immunoassay methodology, is important because it increases test throughput, reduces cost-per-test, and increases test efficiency. The arrays will increase the diagnostic value of tumor markers in cancer diagnosis, assessment of treatment, and basic research in molecular profiling, by allowing the simultaneous quantitative measurement of multiple groups of markers associated with the same types of cancer. The measurement of single tumor marker concentrations currently has limited diagnostic usefulness. The arrays address the primary limitation of existing protein arraying methods, which is concern about denaturing of proteins immobilized on 2-dimensional substrates, by using a hydrophilic 3-dimensional electrode matrix to immobilize proteins. The arrays also have other significant advantages, being highly sensitive, eliminating the need for expensive optical imaging equipment by using economical electrochemical detection methods, being unaffected by sample turbidity, quenching, or interference from absorbing and fluorescing compounds typically found in biological samples, and using instrumentation that is simple and easily miniaturized to circuit board level, facilitating the development economical microanalyzers and methodology for ultra-small sample amounts. The Phase I program demonstrated the feasibility of electrochemical SMAI to detect two different tumor markers in a single sample. The aim of the Phase II program is to refine this technology through the optimization of electrochemical immunosensor preparation and assay design, expansion of the Phase I array to a greater number of immunosensing electrodes, and the development of a prototype array for the simultaneous detection and quantification of multiple tumor markers. The Phase II will focus on developing a robust, reliable and reproducible assaying system.