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Fast, quantitative diagnostic reader offers potential for thousands of medical tests
This medical reader can perform diagnostic tests on any bodily fluid that attenuates light, such as blood, urine, sputum, or other fluid. Thousands of potential tests are possible, including immunoassay, colorimetric/chromogenic tests, HbA1c, cholesterol, HCG, osteoporosis calcium levels, and many more. While most physicians have easy access to lab tests, those tests can be slow and expensive. Consumer versions of tests are inaccurate and have limited scope, and often involve sending a sample to a lab. Physicians, PAs, Emergency Rooms, EMTs, patients, visiting nurses, and caregivers may all need access to quick, accurate tests without waiting for results and making callbacks. Some chronic tests (such as HbA1c for diabetics) require the mixing of reagents, and so are difficult to do at home. This all-in-one diagnostic reader can handle such tests and report results in as few as ten minutes. The prototype performs three identical tests on a single whole-blood sample for accuracy; but a greater number of simultaneous tests could be performed, or a battery of tests could be performed on the same sample. Programming and circuit board design determines the tests that an individual unit performs. All sample handling takes place inside the device. Prototypes indicate that the device will be inexpensive to build. A unique lancet draws blood for the prototype system. It slices the skin and creates a pressure differential to avoid injuring the red blood cells by “milking” (typical of finger sticks). In the prototype, one-button activation isolates a specific region of the Pre-Analytic System, transfers the plasma sample to the main test strip, applies diluents to it, and activates the electronic test protocol. Different activities could be designed into the unit for different tests. Lab-scale production of fully functional injection-molded devices has been undertaken for proof-of-concept, but Kimberly-Clark does not envision that the current apparatus is the final product.hand-held quantitative diagnostic reader measures color density sample perform optical test assay measured attenuation light bodily fluid Potentially thousands assays designed current three photodiodes single chip tests time iterations (for accuracy) particular protocol) larger number LEDs detectors simultaneous depends real estate circuit board device affects overall

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