Point-of-Care Measurement of Glycated Hemoglobin

描述(由申请人提供)：本项目的总体目标是 要完成快速护理点测试的开发和验证， 糖化血红蛋白的测定，这是既定的客观指标 在一段综合时间内环境血糖浓度的变化。我们 采用了特定的化学络合和流体流动的原理 在干试验中分离糖化和非糖化的血红蛋白 条带格式。初步工作表明，该结构具有以下功能 直接应用1微升全血，4次即可完成化验 分钟，并且在两个结合区的颜色强度的比率 试条与应用的糖化血红蛋白的量成比例 与HbA1c的高效液相分析结果相关联。第一阶段是 旨在证明测试系统进一步开发的可行性，该测试系统 需要耐用的手持电子读出设备。的具体目标 第一阶段：a)设计和建造一个原型电子设备， 的糖化和非糖化结合区中的颜色强度 带，计算第一个与第一个和第二个的和的比率， 并提供百分比HbA1c的LCD数字显示；b)优化 试纸的膜组件相对于捕获、流动和 以及c)用测试系统确定结果显示 与糖化血红蛋白的用量成比例的关系 与实验室方法获得的HbA1c值的相关性。在……里面 第二阶段，将完善和最终确定设备的规范， 将定义测试系统的限制，并将性能 将对测试系统的特点进行系统的检查。第二阶段 预计将与合作伙伴合作实现商业化。

DESCRIPTION (provided by applicant): The overall objective of this project is to complete development and validation of a rapid point-of-care test for the measurement of glycolated hemoglobin, which is the established objective index of ambient blood glucose concentration over an integrated period of time. We have adapted the principle of specific chemical complexation and of fluid flow to separate glycated form non-glycated species of hemoglobin in a dry test strip format. Preliminary work indicates that this construct functions with direct application of one microliter of whole blood, completes the assay in 4 minutes, and that the ratio of color intensities in the two binding zones of the strip is proportionate to the amount of glycated hemoglobin applied and correlates with results obtained with HPLC analysis of HbA1c. Phase I is designed to prove feasibility for further development of the test system, which requires a durable, hand-held electronic readout device. The specific aims of Phase I are to: a) design and construct a prototype electronic device that reads color intensity in the glycated and non-glycated binding zones of the strip, calculates the ratio of the first to the sum of the first and second, and provides an LCD number display of the percent HbA1c; b) optimize the membrane components of the assay strip with respect to capture, flow and dispersion properties; and c) establish that results with the test system show a proportionate relationship with the amount of glycated hemoglobin applied and a correlation with HbA1c value obtained with laboratory-based methodologies. In Phase II, the specifications of the device will be refined and finalized, the limits of the testing system will be defined, and the performance characteristics of the test system will be systematically examined. Phase II follow-on with a partner for commercialization is anticipated.