Rapid Identification of Pathogenic Bacteria in Blood causing Sepsis

 描述(申请人提供)：败血症是美国医院死亡的主要原因，占美国医院死亡人数的52%，也是美国医院治疗的最昂贵的疾病，每年花费超过170亿美元。每年生产的血液培养瓶超过3亿瓶，仅在美国和欧盟的市场规模就超过12亿美元。第二阶段为期两年，从2013年2月到2015年2月(5 R44 AI094781-03)。这项研究部分由这笔赠款资助，创造了一种诊断引起败血症的血流感染的新范式。这笔赠款的工作帮助创建了SPECID血液培养系统，该公司目前正在将其商业化。SpecID解决方案取代了目前分为1)感染检测；2)由训练有素的技术人员在工作台上对所有阳性培养进行强制性革兰氏染色；然后3)通过MALDI-TOF进行物种鉴定(同样需要熟练的样品准备)的3)血液样本鉴定过程，specID解决方案在单个全自动化步骤中结合了更快的检测、更准确的革兰氏状态确定和比MALDI更准确的ID，从而缩短了进行ID所需的时间，简化了实验室工作流程，并节省了大量成本。其结果是改善了患者的预后，改善了实验室的操作性能。第二阶段的目标是解决临床人类样本的应用，以及开发适合商业使用的仪器和媒体。该提案的目标反映了实现specID智能培养系统进入商业、大容量实验室所需的主要目标，包括开发specID血培养仪器、血培养瓶传感器附件，以及为证明性能、获得监管批准和进行首次销售而进行的临床和分析研究。

 DESCRIPTION (provided by applicant): Sepsis is the leading cause of deaths in US hospitals contributing to or causing 52% of all US hospital deaths and is the most expensive condition treated in US hospitals, costing more than $17 billion annually. More than 300 million blood culture bottles are produced annually, with a market size greater than $1.2B in the US and EU alone. The two-year phase II period spanned February 2013 to February 2015 (5 R44 AI094781-03). The developments, funded in part by this grant, have created a new paradigm to diagnose blood stream infection causing sepsis. The work of this grant has assisted in creating the SpecID blood culture system, which the company is now commercializing. The SpecID solution replaces the present 3-step process for characterization of blood samples, currently divided into 1) detection of infection; 2) an obligatory Gram stain for all positive cultures performed on the bench by trained technician; and then 3) species ID by MALDI-TOF, (again requiring skilled sample preparation), The SpecID solution combines faster detection, more accurate Gram status determination than the benchtop stain, and ID more accurate than MALDI, in a single fully automated step which reduces the time to ID, streamlines lab workflow, and saves significant cost. The result is improved patient outcomes and improved lab operating performance. Phase IIB aims address application to clinical human specimens along with development of instruments and media appropriate for commercial use. The objectives of this proposal reflect the major goals required to achieve commercial entry of the SpecID smart culture system into commercial, high volume laboratories including development of the SpecID blood culture instrument, blood culture bottle sensor attachment, and the clinical and analytical studies to prove performance, gain regulatory approval and make first sales.