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把这种新型纳米技术应用于肺炎和败血症问题。肺炎是全球第二大死亡原因，在5岁以下儿童中排名第一，也是导致败血症的头号原因。治疗的主流是经验性的抗生素选择，这增加了多重耐药生物体，可能没有适当地解决感染的原因，从而可能增加死亡率。无需中心实验室，在床边或现场10分钟内诊断肺炎病因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。该技术将把该领域带入一个新时代，即在严重感染或败血症发生之前筛查肺炎高危患者。该技术还将成为更好地了解肺炎的自然史和流行病学的缺失工具，因为目前肺炎的致病生物仅在一半的患者中被发现。美国医院每年治疗肺炎和败血症的费用为300亿美元。该技术利用纳米技术大大增加了纳米级结合事件的表面积，这些结合事件是通过阻抗的变化来测量的，然后与目标生物标志物的浓度相关。该技术将使肺炎领域从目前的定性结果转向定量读数。肺炎常见病因的检测可以通过一滴血液、尿液和/或唾液来完成。构建含肺炎生物标志物的合成溶液。分析参数包括准确度、精密度、线性度、校准、空白限、检测限、功能灵敏度和干扰物质将被评估。此外，将确定一次性传感器墨盒的最佳制造工艺。这将包括干法与湿法生物化学的评估，适当的制造方法，精度，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.