Point-of-Care Measurement of Glycated Hemoglobin

描述(由申请人提供)：该第二阶段项目将完成糖化血红蛋白快速测试的开发和验证，该测试适合在护理地点环境中使用。该测试系统由插入手持电子设备中的一次性干试纸条组成，该手持电子设备读取该试条中分别捕获所应用样本中的糖化和非糖化血红蛋白的两个相连区域中的每一个的颜色强度，计算第一区域中的颜色与这两个区域中的颜色强度总和的比率，并在液晶显示器上提供糖化血红蛋白的百分比。第一阶段的目标是设计和建造一个原型电子设备，根据捕获、流动和分散特性优化测试条的组件，并证明测试系统的结果与实验室方法获得的HbA1c值具有相关性。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)完善和最终确定设备(读取器)的编程、处理和其他规范；b)确定测试系统在样本收集、时间和稳定性方面的限制；e)系统地检查测试系统的性能特征，包括线性干扰和专属性、准确度和精密度；d)评估毛细血管和静脉采样结果的可比性；e)用来自NGSP的赋值样本使测试系统标准化；f)证明测试系统与批准的实验室方法基本等同；g)将结果提供给潜在的商业化合作伙伴；以及h)整理和分析数据，以便向FDA提交批准上市的申请。

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.