Point-of-Care Measurement of Glycated Hemoglobin

描述（由申请人提供）：该二期项目将完成糖化血红蛋白快速测试的开发和验证，该测试适用于即时护理环境。测试系统由一次性干条带组成，插入手持电子设备，读取条带中两个连接区域中的每个区域的颜色强度，分别捕获应用样品中的糖化和非糖化血红蛋白，计算第一个区域的颜色与两个区域的颜色强度之和的比例，并在液晶显示器中提供糖化血红蛋白的百分比。第一阶段的目标是设计和构建一个原型电子设备，优化测试条的捕获、流动和分散性能，并证明测试系统的结果与实验室方法获得的糖化血红蛋白值存在相关性。这些第一阶段的里程碑已经完成。第二阶段的具体目标是：a)完善和确定设备（阅读器）的编程、加工和其他规格；B)确定检测系统在样品采集、定时和稳定性方面的极限；E)系统地检查测试系统的性能特征，包括线性干扰和专一性、准确性和精密度；D)评估毛细血管和静脉取样结果的可比性；e)使用NGSP中指定值的样品对测试系统进行标准化；F)证明测试系统与经批准的实验室方法在实质上是等效的；G)向潜在的商业化合作伙伴展示成果；和h)整理和分析数据，以提交给FDA批准上市申请。

DESCRIPTION (provided by applicant): This Phase II project will complete development and validation of a rapid test for measurement of glycated hemoglobin that is suitable for use in the point-of-care setting. The test system consists of disposable dry strips that are inserted into a hand-held electronic device that reads the color intensity in each of two conjoined zones in the strip that respectively capture glycated and non-glycated hemoglobin in an applied sample, calculates the ratio of color in the first zone to the sum of color intensities in the two zones, and provides the percent glycated hemoglobin in a liquid crystal display. The Phase I goals were to design and construct a prototype electronic device, optimize components of the test strips with respect to capture, flow and dispersion properties, and demonstrate that results with the test system show correlation with HbA1c values obtained with laboratory-based methodologies. These Phase I milestones have been accomplished. The specific aims of Phase II are to: a) refine and finalize programming, processing and other specifications of the device (reader); b) define limits of the testing system with respect to sample collection, timing and stability; e) systematically examine performance characteristics of the test system including linearity interference and specificity, accuracy and precision; d) evaluate comparability of results between capillary versus venous sampling; e) standardize the test system with value-assigned samples from the NGSP; f) demonstrate substantial equivalence of the test system to an approved laboratory method; g) present results to prospective commercialization partners; and h) collate and analyze data for submission of an application to the FDA for approval for marketing.