MAQDOTS: Multi-Analyte Quantum Dot Test Strips

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DESCRIPTION (provided by applicant): Over five million patients are admitted annually to cardiac care units (CCU) for suspected acute myocardial infraction (AMI). The majority of these patients are ruled out of AMI and are subsequently released. A simple method to diagnose patients suffering from AMI from those with other ailments would save billions of dollars, free up CCU units for AMI patients, offer superior care, and save lives of patients. The National Academy of Clinical Biochemists recommended that a quantitative measurement of a panel of cardiac markers within a few hours of the onset of symptoms at excellent precision from body fluids such as blood or serum could improve AMI diagnosis. However, a quantitative, easy-to-use, precise, rapid, test unit for monitoring cardiac markers indicative of AMI is not readily available. This has largely been due to the lack of an affordable, sufficiently sensitive, portable detection system. To solve this important problem, Intelligent Optical Systems, in collaboration with Scripps Laboratories, proposes to develop semiconductor rianocrystal (Quantum Dot) based lateral flow test strips, combined with a sensitive and inexpensive readout device, for detecting and quantifying multiple arialytes in body fluid samples. lOS's proposed approach is a novel use of nanomaterials for in vitro diagnostics, and is expected to expand the scope and capabilities of lateral flow test strips. In Phase I, the feasibility of the principle will be demonstrated by fabricating the required sensing nanomaterials, designing appropriate test strips, constructing an optical reader to measure the response from the test strips, and then testing and validating the strips by comparing their performance against current clinical standards. In Phase I, cardiac markers, including Myoglobin, CK-MB, and Troponin I spiked in serum will be used to demonstrate the feasibility of the principle. The overall goal of this proposal is to develop a new technical approach for lateral flow test strip development and this basic approach can also lead to the development of test kits for other important biomedical, process monitoring, and environmental sensing applications, as well as in other testing of body fluids, such as urine and saliva. These dramatic improvements in clinical diagnostics will also have far reaching benefits to environmental monitoring, homeland defense, and biothreat detection. In Phase II, we will continue to optimize the membrane chemistry and the biolabeling of QDs to achieve more sensitive and precise multianalyte test strips. A prototype optical detection system will be developed and optimized to achieve high sensitivity and a suitable dynamic range. Phase II work will also involve extensive testing with a larger panel of samples and clinical trials to understand the reliability of the device for AMI diagnosis.