Microchip Assay for Serum Creatinine

描述(由申请人提供)：项目摘要/摘要：目前，估计有800万美国人患有严重的肾脏损伤，而且这个数字还在增长。每年死于肾衰竭的人比死于结肠癌、乳腺癌或前列腺癌的人多。到2010年，慢性肾脏疾病的估计医疗和其他经济成本预计将接近每年280亿美元，另外还有900亿美元的年成本与增加的心血管疾病、感染和住院有关。评估肾功能最常用的方法是用血清(Scr)测定肌酐。存在多种允许SCR测定的方法。最便宜的品种依赖于间接检测：添加一种试剂，该试剂专门与SCR反应，得到一种易于检测的化合物。无一例外，间接方法受到其他标本物种的干扰，导致评估的可信度较低。SCR的直接检测是可能的，但需要昂贵和复杂的仪器，如高效液相色谱(HPLC)。Advanced MicroLabs，LLC(AML)致力于为未来的监测设备开发我们独特的微芯片毛细管电泳电化学检测(微芯片CE-EC)技术。我们的设备将能够在一个火柴盒大小的一次性芯片上测量数百种分析。分析将是快速(约3分钟)和廉价的。该设备将是用户友好的，在护理或临床情况下操作。最重要的是，因为我们的设备直接检测可控硅，所以它受到的干扰很小。虽然这项建议侧重于SCR分析，但我们的系统可以修改为同时测定多个肾脏疾病标记物。第一阶段的结果将建立一个从全血样本开始的微芯片CE-EC检测SCR的采样方案。使用稀释、过滤和层析，将唯一地检测到SCR。在第二阶段，所有程序将合并为一个独立的、集成的微芯片格式。项目简介：目前，估计有800万美国人患有严重的肾脏损伤，而且这个数字还在增长。我们建议的医疗设备将使医生能够更快、更准确、更可靠、更少侵入性地诊断肾脏损伤。

DESCRIPTION (provided by applicant): Project Summary/Abstract: Currently, an estimated 8 million Americans have substantial kidney impairment and this number is growing. More people die annually from kidney failure than from either colon cancer, breast cancer, or prostate cancer. Estimated medical and other economic costs of chronic kidney disease are expected to approach $28 billion annually by 2010, with an additional $90 billion in annual costs related to increased cardiovascular disease, infections, and hospitalizations. The most commonly measured species for renal function assessment is creatinine, measured in blood serum (Scr). A variety of methods exist that allow for Scr determination. The least expensive variety rely on indirect detection: a reagent is added that specifically reacts with Scr to give an easily detected compound. Without exception, indirect methods suffer interferences from other specimen species resulting in less confident assessments. Direct detection of Scr is possible, but requires expensive and complicated instrumentation, such as, High Performance Liquid Chromatography (HPLC). Advanced MicroLabs, LLC (AML) is dedicated to the development of our unique Microchip Capillary Electrophoresis with Electrochemical Detection (Microchip CE-EC) technology for tomorrow's monitoring devices. Our device will be capable of measuring hundreds of assays on a single, disposable chip about the size of a matchbook. Analysis will be quick (ca. 3 min) and inexpensive. The device will be user-friendly, operate in a point of care or clinical situation. Most importantly, because our device detects Scr directly, it will suffer little interference. While this proposal focuses on a Scr assay, our system is amendable to simultaneous determination of multiple renal disease markers. Phase I results will establish a sampling protocol for Microchip CE-EC detection of Scr starting with a whole blood sample. Using dilutions, filtering, and chromatography, Scr will be uniquely detected. In Phase II, all procedures will be combined into a self-contained, integrated, microchip format. Project Narrative: Currently, an estimated 8 million Americans have substantial kidney impairment and this number is growing. Our proposed medical device will allow medical practitioners to diagnose kidney impairment faster, more accurately, more reliably, and less intrusively.