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

这个小企业创新研究第一阶段项目将应用新的纳米技术来解决肺炎和败血症的问题。 肺炎是全球第二大死亡原因，在5岁以下儿童中居首位，也是败血症的头号原因。治疗的主要方法是经验性抗生素选择，这会增加多药耐药微生物，可能无法适当解决感染的原因，从而可能增加死亡率。在床边或现场10分钟内诊断肺炎病因而无需中心实验室的广泛影响将产生新的范例，并降低患者死亡率，成本和多重耐药微生物。该技术将使该领域进入一个在严重感染或败血症发生之前筛查肺炎高危患者的新时代。该技术还将作为更好地了解肺炎自然史和流行病学的缺失工具，因为目前肺炎的病原体仅在一半患者中发现。美国医院每年治疗肺炎和败血症的费用为300亿美元。该技术使用纳米技术大大增加了纳米级结合事件的表面积，这些事件通过阻抗变化进行测量，然后与目标生物标志物的浓度相关联。 该技术将使肺炎领域从目前的定性结果转向定量阅读。肺炎常见病因的检测将通过一滴血液、尿液和/或唾液来完成。将构建具有肺炎生物标志物的合成溶液。 将评价分析参数，包括准确度、精密度、线性、校准、空白限、检测限、功能灵敏度和干扰物质。 此外，将确定一次性传感器盒的最佳制造工艺。这将包括评估干与湿生化、适当的制造方法、准确度、校准、储存、温度、老化和最终设计概念。拟议研究的目标是生产传感器盒的alpha原型，可以从血液，尿液和唾液的合成溶液中检测肺炎生物标志物。

This Small Business Innovation Research Phase I project will apply the novel nanotechnologyto 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 mainstayof treatment is empiric antibiotic selection, which increases multidrug resistant organismsand may not appropriately address the cause of the infection, thus potentially increasingmortality. 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.