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. ? ? ?
