Non-instrumented Device for Diabetic/Vascular Risk S

描述（由申请人提供）：世界上超过一半的糖尿病患者和由于高血糖和高血脂（胆固醇，甘油三酯）而有动脉粥样硬化风险的个体未被诊断。在这个庞大的患者群体中，一个快速增长的组成部分是患有代谢综合征的人。大多数受试者通常不知道严格控制血糖、改变生活方式、或服用降血糖或降脂药物的益处，因为他们通常不使用或很少接触护理设施和检测。由于这个原因，并由于巨大的相关社会经济影响，国家和世界专业团体越来越多地提倡通过病例识别和干预进行预防。为此，已经提出了基于全国共识的葡萄糖、胆固醇和甘油三酯临界值，用于筛查、风险分层和干预。在这些趋势的推动下，我们建议开发一种紧凑的、无仪器的、微创的测试棒方法，旨在视觉上识别单个测试条上提出的切割点。使用专利的毛细管微流控技术，该装置将微型血液样本剂量和运输到六(6)个聚合物检测点（测试场），代表三(3)种分析物中的每一种的两(2)个水平。通过毛细管力去除血细胞后，用户可同时评估6个水平。切割点的视觉识别是通过一种新的酶阈值测定原理实现的，其中只有那些试验场显示血液水平高于共识切割点的颜色。根据测试区显示的颜色，可以制定治疗（改变生活方式，降糖或降脂药物），预防或延缓疾病的发展。该设备的另一个新颖之处在于，它将所有测试组件和步骤整合到一个一次性塑料中，使测试性能非常容易和安全。该设备有望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。在场外销售该产品被视为主要的市场应用。在提案中详细介绍了实现既定发展目标的研究设计和方法。应用的重点学科有临床化学、干试纸技术、酶学、机械工程和流动注射成型。关键的I期目标是开发酶促甘油三酯测定并证明其分析性能。这将应用临床和实验室标准协会（CLSI）（前身为NCCLS）制定的敏感性、特异性、方法比较和精度指南进行。

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.