As recommended by the National Cholesterol Education Program, the measurement of LDL-cholesterol levels in blood has become the primary means for detection, evaluation and treatment of individuals at risk for developing Coronary Heart Disease. Despite its importance, there is currently no direct, one-step method for the determination of LDL- cholesterol levels that can be performed as a point-of-care test This Phase I study will focus on developing a disposable dry-chemistry test cartridge for the rapid measurement of LDL-cholesterol. The cartridge will be comprised of multiple membrane layers that will permit, sequentially, the separation of plasma from blood, separation of LDL- cholesterol by selective immuno-complexation of HDL, VLDL and chylomicron fractions, and the subsequent measurement of LDL-cholesterol enzymatically (via cholesterol esterase/oxidase/peroxidase). The color produced from the indicator reaction will be measured via GDS's existing Stat-SiteR reflectance meter. The final test cartridge will enable the measurement of LDL-cholesterol on-site within 2-5 minutes using a drop of whole blood. Success of Phase III studies will lead to the commercialization of a convenient LDL-cholesterol test that will be marketed to hospitals, physicians' offices and potentially for home use.Proposed commercial application:An accurate, precise and inexpensive method for the measurement of LDL-cholesterol at the point of patient care by non-skilled individuals would be an invaluable tool in continued efforts to assess the risk of Coronary Heart Disease for the general population. In addition, the proposed test will be useful for monitoring patients who are on diet and/or drug therapy for reducing LDL levels. Thus, there is a large potential market for the proposed new test.National Institute of Heart, Lung, and Blood Institute (NHLBI)
