SBIR Phase I: Optical Platform for Point-of-Care Analysis With a Single Drop of Blood

This SBIR Phase I project will develop a point-of-care (POC) blood chemistry test that can measure multiple analytes simultaneously with a single drop of blood. Blood chemistry tests are the most frequently ordered tests by physicians. This proposed lab-on-a-chip and associated analyzer for blood chemistry tests will benefit society by improving the quality of health care delivery and reducing costs. This device?s minimally invasive procedure reduces: fear and discomfort caused by needles, level of skill needed for sample collection, and errors associated with pre-analytical testing steps. The device?s patent-protected optode technology, which utilizes the color spectrum to measure concentrations, differentiates it from electrochemical technology, which is used by competing POC devices. Briefly, optode technology has lower manufacturing complexity, requires much less blood, has a more robust output, and can test more analytes simultaneously. The initial target application will be neonatal blood chemistry testing because of a strong need to minimize blood draw volumes. Upon clinical acceptance of the technology in the neonatal market, the simple-to-use platform will be expanded to other applications, including acute care centers, first responders, primary care, military care, and disaster relief organizations. This platform will also be expanded to test many other analytes, and should help create many new U.S. jobs in the process. The proposed optode-based lab-on-a-chip device will be capable of testing various analytes simultaneously with a single drop of blood, which has not been achieved by commercial POC devices. This innovative optode technology has several advantages over electrochemical technology. First, the optode technology enables extremely small sample volume requirements compared to electrochemical sensors (6-10 ìL vs. 65-100 ìL) and eliminates the need for mixing of reagents. Second, fabrication complexity is greatly simplified using optodes because it requires less layers, less raw materials, and simpler manufacturing steps. Third, optode technology provides a more robust output by using a combination of multiple wavelengths on the visual light spectrum and not a single current output as used in electrochemical technology. Finally, this platform technology will result in unique multiplex analyte combinations, including the first ever handheld basic metabolic panel (BMP) test that requires just a single drop of blood. The primary goal of this Phase I SBIR is to demonstrate feasibility of this micro-dispensed, lab-on-a-chip system to evaluate clinical samples. In this one-year project, Objective 1 will develop automated sensor manufacturing methods. Objective 2 will confirm the performance of the developed lab-on-a-chip to quantify analytes in sera samples in FDA-required non-clinical tests and when compared to an FDA-approved, POC analyzer.