Point-of-Care Measurement of Glycated Hemoglobin

糖化血红蛋白的护理点测量

• 批准号: 6744151
• 负责人: MARGO COHEN
• 金额: $ 28.77万
• 依托单位: EXOCELL, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-06-15 至 2005-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6744151
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; blood glucose; blood tests; clinical research; computer program /software; diabetes mellitus; diagnosis design /evaluation; diagnosis quality /standard; glycation; hemoglobin As; high performance liquid chromatography; human subject; human tissue; hyperglycemia; information display; measurement; miniature biomedical equipment; portable biomedical equipment; rapid diagnosis

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.

描述（由申请人提供）：此II期项目将完成适用于糖化血红蛋白的快速测试的开发和验证，该测量适合在护理点环境中使用。测试系统由一次性干燥条组成，这些干条被插入了手持电子设备中，该设备读取条带中的两个连接区域中的每个相连区域中的颜色强度，该区域分别捕获了应用样品中的糖化和非糖化血红蛋白，可以计算出第一个颜色的颜色比例，并在两个液体中提供液体的颜色，并在两个液体中提供Zones和sshive of shouper的颜色，并提供了百分比的gycl glycin和百分之一的Glylcin。第一阶段的目标是设计和构建一个原型电子设备，优化测试条的组件相对于捕获，流动和分散属性，并证明了测试系统的结果表明与基于实验室方法论获得的HBA1C值相关。这些I阶段的里程碑已经完成。第二阶段的具体目的是：a）精炼和完成设备的编程，处理和其他规范（读者）； b）定义测试系统的限制，相对于样本收集，时机和稳定性； e）系统地检查测试系统的性能特征，包括线性干扰和特异性，准确性和精度； d）评估毛细管与静脉采样之间的结果的可比性； e）用NGSP的价值分配样品标准化测试系统； f）证明了测试系统与批准的实验室方法的实质性等效性； g）向潜在的商业化伙伴提出结果； h）整理和分析数据以向FDA提交申请以供营销批准。