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人没有得到诊断。在这个庞大的患者群体中，有一个快速增长的组成部分是代谢综合征患者。这些受试者中的大多数人通常不知道，因此被剥夺了严格控制血糖、改变生活方式或服用降糖或降脂药物的已证明的好处，因为他们经常不利用或有限地获得护理设施和检测。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主张通过病例识别和干预来进行预防。为此，已经提出了基于全国共识的血糖、胆固醇和甘油三酯的临界点水平，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、非仪器和微创的测试棒方法，旨在直观地识别一(1)个单独测试条上的建议切入点。该设备使用获得专利的毛细管微流控技术，将微型血液样本剂量和传输到六(6)个聚合检测位置(试验场)，代表三(3)个分析物中的每一个的两(2)个水平。用毛细管力去除血细胞后，6个水平可由用户同时评估。切点的视觉识别是通过一种新的酶阈值分析原理实现的，其中只有那些测试场显示血液水平高于共识切点的颜色。根据测试区域显示的颜色，可以实施治疗(改变生活方式、降糖或降脂药物)，防止或延缓疾病的发展。该设备的另一个新特点是，它将所有测试组件和步骤整合到一个塑料一次性中，使测试性能极其轻松和安全。预计该设备将在一个非常大的市场上发挥重要的、必要的分析和教育作用。以柜台模式销售该产品被视为主要的市场应用。提案中详细说明了实现所述发展目标的研究设计和方法。将应用的关键科学学科是临床化学、干试纸条技术、酶学、机械工程和流动注射成型。第一阶段的主要目标是开发酶促甘油三酯分析方法，并展示其分析性能。这将遵循临床和实验室标准协会(CLSI，前身为NCCLS)关于敏感性、特异性、方法比较和精密度的指南。

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.