SBIR Phase I: Point of Care Device for High Frequency Stratification of Patient Populations at Risk of Sepsis

This SBIR Phase I project proposes to develop a device for better, early screening of sepsis. Sepsis costs the U.S. health care system over $24 billion every year, with as many as 3.1 million cases that claim over 300,000 lives annually. One out of every two to three hospitals deaths in the U.S. is due to sepsis. There are an estimated >19 million cases worldwide, and some reports have estimated that 1 person dies from sepsis every 4 seconds. Mortality rates due to severe sepsis are between 20% and 50%. The most urgent problem is a lack of accurate early screening methods. Survival rates drop by 7.6% per hour treatment is delayed. Current screening for sepsis utilizes the SIRS criteria, which include temperature, heart rate, respiratory rate, and total WBC count. These parameters have very low specificity for early screening of sepsis. This project will replace these parameters with a panel of cell and protein biomarkers to provide highly specific and sensitive detection and stratification for sepsis. A hand-held point-of-care device and a one-time-use cartridge capable of providing total white blood count, lymphocyte, granulocyte/monocyte, and CD64 Neutrophils all from one drop of blood in a single cartridge will be developed. Such a system could save hundreds of thousands of lives and billions of dollars in healthcare costs every year in the United States. This project will develop a point of care sensor that can measure cell counts and proteins from a drop of blood. The technology combines the power of microfluidics, microfabrication, and on-chip electrically based cell and particle counting to develop a revolutionary new technology that combines electrical coulter counting with immuno-capture of cells and particles. The developed device would be the only one with the capability to offer in a single device the critical information of hematology analyzers, flow cytometers, protein, and DNA assays. This project enables the power of all of these tools to be harnessed from a single inherently simple, powerful, and scalable, platform. Such a device could dramatically increase both the frequency and the multiplexing of sampling of biomarkers from patient populations. In this proposal, commercial grade cartridges will be used to develop protein measurements for procalcitonin, an FDA approved biomarker for sepsis, in addition to cell counting, from drop of blood of healthy and sick patients from hospital settings.