A Novel Device for Determination of GFR Markers

描述(申请人提供)：约有2000万美国人患有慢性肾脏疾病，另有2000万人处于危险之中。肾小球滤过率(GFR)是反映肾功能的最佳指标之一。它是通过测量血液中某些标志物的消失率和它们在尿液中的出现来确定的。目前使用的测量GFR的方法要么昂贵、困难，要么需要放射性标记物、专门的设施和训练有素的人员。因此，迫切需要开发一种简便、快速、不需要使用放射性标志物、准确和经济的GFR测量方法。为了满足这一需求，Lynntech正在提议开发一种简单的设备来测量GFR，该设备使用非放射性的碘化标记物，如硫代氨基甲酸盐。该装置基于一种结合了电化学、固相萃取(SPE)和比色法的创新方法。在该项目的第一阶段，Lynntech将研究将这一创新的电化学结合固相萃取和比色法用于准确测定GFR的可行性。该方法将用血液/血清和尿样进行测试，并将结果与印第安纳大学用标准高效液相色谱法测定GFR标记物的结果进行比较。在第一阶段获得的优化条件将用于设计、制造和测试原型装置，以便在第二阶段快速准确地测量GFR。

DESCRIPTION (provided by applicant): About 20 million Americans have chronic kidney disease while an additional 20 million are at risk. Glomerular Filtration Rate (GFR) is one of the best indexes of kidney function. It is determined by measuring the rate of disappearance of certain markers from blood and their appearance in the urine. Currently used methods for measuring the GFR are either expensive, difficult, or require radioactive markers, and specialized facility and trained personnel. Thus, there is a great need to develop a convenient and rapid method for GFR measurement that does not require use of radioactive markers, is accurate and costeffective. In order to satisfy this need, Lynntech is proposing the development of a simple device to measure GFR using non-radioactive iodinated markers such as iothalamate. This device is based on an innovative method that combines electrochemistry, solid phase extraction (SPE) and colorimetry. During Phase I of this project, Lynntech will investigate the feasibility of using this innovative combination of electrochemistry in conjunction with SPE and colorimetry for accurate determination of GFR. This method will be tested with blood/serum and urine samples and the results compared to that obtained using standard HPLC method for determination of the GFR markers at Indiana University. The optimized conditions obtained during the Phase I will be used for designing, fabricating and testing of a prototype device for rapid and accurate measurement of GFR during Phase II.