Point-of-Care Measurement of Glycated Hemoglobin

描述（由申请方提供）：本II期项目将完成适用于即时护理环境的糖化血红蛋白快速检测试剂盒的开发和验证。该测试系统由插入手持电子设备的一次性干条组成，该手持电子设备读取条中分别捕获所应用样品中的糖化血红蛋白和非糖化血红蛋白的两个联合区域中的每一个中的颜色强度，计算第一区域中的颜色与两个区域中的颜色强度之和的比率，并在液晶显示器中提供糖化血红蛋白百分比。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，流动和分散特性的组件，并证明测试系统的结果与基于实验室的方法获得的HbA 1c值相关。这些第一阶段的里程碑已经完成。第II阶段的具体目标是：a）完善和最终确定器械（读数器）的编程、处理和其他质量标准; B）定义检测系统在样本采集、时间和稳定性方面的限值; e）系统检查检测系统的性能特征，包括线性干扰和专属性、准确度和精密度; d）评价毛细血管与静脉取样结果的可比性; e）用NGSP的赋值样品对试验系统进行标准化; f）证明试验系统与批准的实验室方法实质等同; g）向潜在的商业化合作伙伴展示结果; h）整理和分析数据，以便向FDA提交上市申请。

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.