Non-instrumented Device for Diabetic/Vascular Risk S

描述（由申请人提供）：世界上一半以上的糖尿病患者和因高血糖和高血脂（胆固醇、甘油三酯）而有动脉粥样硬化风险的个体未被诊断。在这一庞大的患者群体中，代谢综合征患者的数量迅速增加。这些受试者中的大多数通常不知道并因此被剥夺了严格葡萄糖控制、生活方式改变或降糖或降脂药物的已证实益处，因为他们通常不利用护理设施和检测或获得护理设施和检测的机会有限。出于这个原因，并由于相关的巨大社会经济影响，国家和世界专业团体越来越多地倡导通过病例识别和干预进行预防。为此，已提出基于国家共识的葡萄糖、胆固醇和甘油三酯临界点水平用于筛查、风险分层和干预。受这些趋势的影响，我们建议开发一种紧凑、非仪器化和微创的测试棒方法，旨在视觉上识别一（1）个单独测试条上的拟定临界点。使用专利的毛细管微流控技术，该设备的剂量和运输微型血液样本到六（6）聚合物检测位点（测试领域），代表两（2）水平的三（3）分析物。通过毛细作用力去除血细胞后，用户可以同时评估6个水平。通过一种新的酶阈值测定原理实现了切割点的视觉识别，其中只有那些测试区域显示血液水平高于共有切割点的颜色。根据哪些测试字段显示颜色，可以制定治疗（生活方式改变，降糖或降脂药物），预防或延迟疾病发展。该设备的另一个新功能是将所有测试组件和步骤整合到一个一次性塑料中，使测试性能变得非常简单和安全。该设备预计将在一个非常大的市场中发挥重要和必要的分析和教育作用。以非处方模式销售产品被视为主要市场应用。提案中详细说明了实现所述发展目标的研究设计和方法。应用的关键科学学科是临床化学、干试纸技术、酶学、机械工程和流动注射成型。关键的I期目标是开发酶法甘油三酯测定并证明其分析性能。将采用临床和实验室标准化研究所（CLSI）（前身为NCCLS）规定的灵敏度、特异性、方法比较和精密度指南进行研究。

DESCRIPTION (provided by applicant): More than half of the world's diabetics and individuals at risk for atherosclerosis due to high blood glucose and lipids (cholesterol, triglyceride) are undiagnosed. A fast growing component of this huge patient population are people with metabolic syndrome. Most of these subjects are generally unaware and thus deprived of the proven benefits of tight glucose control, lifestyle modification, or glucose or lipid lowering medication, because they often do not utilize or have limited access to care facilities and testing. For this reason, and because of the enormous associated socioeconomic implications, National and world professional groups increasingly advocate prevention through case identification and intervention. To this end, National consensus-based cut-point levels for glucose, cholesterol and triglyceride have been proposed for screening, risk stratification and intervention. Motivated by these trends, we propose to develop a compact, non-instrumented, and minimally invasive test wand method designed to visually recognize the proposed cut-points on one (1) individual test strip. Using a patented capillary microfluidic technology, the device doses and transports a miniature blood sample to six (6) polymeric detection sites (test fields), representing two (2) levels for each of the three (3) analytes. After removal of blood cells by capillary force, the 6 levels can be simultaneously evaluated by the user. Visual recognition of the cut-points is enabled by a novel enzymatic threshold assay principle wherein only those test fields show color on which blood levels are higher than the consensus cut-points. Depending on which test fields show color, treatment (lifestyle changes, glucose or lipid lowering medication) can be instituted, preventing or delaying disease development. Another novel feature of the device is that it consolidates all testing components and steps into a single plastic disposable, making test performance extremely easy and safe. The device is expected to have an important and needed analytical, as well as educational role in a very large market. Sale of the product in an over-the-counter mode is seen as the primary market application. Research design and methods for achieving stated development goals are detailed in the proposal. The key scientific disciplines to be applied are clinical chemistry, dry test strip technology, enzymology, mechanical engineering and flow injection molding. The key Phase I objective is to develop the enzymic triglyceride assay and demonstrate its analytical performance. This will be pursued applying the guidelines for sensitivity, specificity, method comparison and precision set forth by the Clinical and Laboratory Standards Institute (CLSI), formerly NCCLS.