SBIR Phase I: Nanotechnology enabled point of care diagnosis for pneumonia and sepsis

This Small Business Innovation Research Phase I project will apply the novel nanotechnology to the problem of pneumonia and sepsis. Pneumonia is the second worldwide cause of death and first among children under 5 years old, and is the number one cause of sepsis. The mainstay of treatment is empiric antibiotic selection, which increases multidrug resistant organisms and may not appropriately address the cause of the infection, thus potentially increasing mortality. The broader impact of diagnosing the cause of pneumonia at the bedside or in the field within 10 minutes with no need for a central laboratory will produce a new paradigm and decrease patient mortality, cost, and multi-drug resistant organisms. The technology will move the field to a new era of screening high risk patients for pneumonia, before severe infection or sepsis occurs. The technology will also serve as the missing tool to greater understand the natural history and epidemiology of pneumonia, as the causative organism in pneumonia is only found in half of patients at present. The annual cost for pneumonia and sepsis in United States hospitals is $30 billion. The technology uses nanotechnology to greatly increase the surface area for nanoscale binding events that are measured with changes of impedance which are then correlated to a concentration of the target biomarker. The technology will move the pneumonia field from the current qualitative result to a quantitative reading. The detection of common causes of pneumonia will be accomplished from a drop of blood, urine, and/or saliva. Synthetic solutions with pneumonia biomarkers will be constructed. Analytical parameters including accuracy, precision, linearity, calibration, limit of blank, limit of detection, functional sensitivity, and interfering substances will be evaluated. In addition, the optimum manufacturing process for a disposable sensor cartridge will be determined. This will include an assessment of dry versus wet biochemistry, appropriate manufacturing method, accuracy, calibration, storage, temperature, ageing, and final design concepts. The goal of the proposed research is to produce an alpha prototype of the sensor cartridge that can detect the pneumonia biomarkers from synthetic solutions of blood, urine, and saliva.