Point-of-Care Measurement of Glycated Hemoglobin

描述（由申请人提供）：本项目的总体目标是 完成快速护理点检测的开发和验证， 糖化血红蛋白的测量，这是既定的客观指标 环境血糖浓度在一个完整的时间段。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血红蛋白 条格式。初步工作表明，这种结构的功能与 直接应用1微升全血，在4分钟内完成测定 分钟，并且两个结合区中的颜色强度的比率 所述条带与所施加的糖化血红蛋白的量成比例， 与HbA 1c的HPLC分析结果相关。一期 旨在证明进一步开发测试系统的可行性， 需要耐用的手持式电子读出装置。的具体目标 第一阶段是：a）设计和构建一个原型电子设备， 读取糖基化和非糖基化结合区的颜色强度， 条带，计算第一条与第一条和第二条之和的比率， 并提供百分比HbA 1c的LCD数字显示; B）优化 分析条的膜组件在捕获、流动和 分散特性;和c）用测试系统确定结果， 与应用的糖化血红蛋白量成比例关系， 与通过实验室方法获得的HbA 1c值的相关性。在 第二阶段，设备的规格将得到完善和最终确定， 测试系统的限制将被定义，性能 将系统地研究测试系统的特性。二期 预计将与一个商业化伙伴开展后续工作。

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.