Consolidated Diabetes Screening Device

描述(申请人提供)：在全球1.2亿糖尿病患者中， 一半的人没有得到诊断，因此被剥夺了已证实的紧凑型药物的好处 血糖控制在控制糖尿病相关并发症中的作用。认识到这一点 问题：美国糖尿病协会和国家糖尿病数据集团 倡导将未确诊糖尿病的筛查作为一项重要的医疗保健 努力吧。由于其临床效率很高，推荐的筛查测试 空腹血糖(空腹血糖110 mg/dL=空腹血糖受损；空腹血糖126 Mg/dL=糖尿病)。该申请组织提议制定一项契约， 无器械、微创、几乎无痛的测试舌片方法 旨在直观地识别这些空腹血糖临界值。通过一种 专有的毛细管体系结构，该设备提供和输送血液 从纳升范围内的样品到两个集成的聚合物检测位置，一个 对于110 mg/dL的空腹血糖，另一种是126 mg/dL的空腹血糖。检测地点 包括干式葡萄糖试剂以及能够吸收的组合物 限定的血浆体积，同时抑制血液中的细胞成分 不能穿透构图。蜂窝组件完全从 通过专有的化学和物理机制检测地点。这就避免了 需要单独的细胞过滤材料，允许异常 方法小型化程度高。两个分界点的视觉识别 水平是通过专有的酶氧化还原阈值分析来实现的 原则性的。 建议的商业应用： 该设备有可能通过专业的、有监督的大众和自我筛查来识别数百万未诊断的糖尿病患者和那些糖耐量受损的人患显性糖尿病的风险。由于对抗糖尿病并发症的治疗方法已经确立，这些人错过了认识和治疗他们的病情并过上健康的生产性生活的机会。

DESCRIPTION (provided by applicant): Of the 120 million diabetics in the world, one half are undiagnosed and therefore deprived of the proven benefits of tight glucose control in curbing diabetes-related complications. Recognizing this problem the American Diabetes Association and National Diabetes Data Group advocate screening for undiagnosed diabetes to be an important health-care endeavor. Owing to its high clinical efficiency, the recommended screening test is fasting plasma glucose (FPG>110 mg/dL=impaired fasting glucose; FPG>126 mg/dL=diabetes). This applicant organization proposes to develop a compact, non-instrumented, minimally invasive and virtually painless test tab method designed to visually recognize these FPG cut-off levels. By means of a proprietary capillary architecture, the device doses and transports a blood sample in the nanoliter range to two integrated polymeric detection sites, one for the 110 mg/dL, the other for the 126 mg/dL FPG level. The detection sites embody the dry glucose reagents, as well as a composition capable of absorbing a defined volume of blood plasma while inhibiting cellular component of blood from penetrating the composition. Cellular component is wholly removed from the detection sites by proprietary chemical and physical mechanisms. This obviates the need for a separate cell filtering material, permitting an exceptionally high degree of method miniaturization. Visual recognition of the two cut-off levels is accomplished by a proprietary enzymic redox threshold assay principle. PROPOSED COMMERCIAL APPLICATIONS: The device has the potential to identify by professional, supervised mass, and self-screening millions of undiagnosed diabetics and those with impaired glucose tolerance at risk to develop overt diabetes. Since therapeutic remedies to combat diabetic complications are well established, these people miss out on the opportunity to have their condition recognized and treated, and live healthy productive lives.