Rapid Identification of Pathogenic Bacteria and Sepsis Diagnosis

描述（由申请人提供）：败血症是美国第十大死亡原因，也是重症监护病房（ICU）第二大死亡原因。败血症每年导致超过21.5万美国人死亡——超过乳腺癌、肺癌和前列腺癌的总和。快速识别和确定抗生素敏感性对于有效治疗感染患者至关重要。第一阶段成功地证明了iSense系统区分细菌种类和菌株的能力，比传统方法单独识别物种快4倍。在I期试验中，iSense还成功地证明了比常规方法快1天以上确定菌株对抗生素治疗敏感性的能力。第二阶段的目标是解决临床人类标本的应用，同时开发适合商业用途的仪器和培养基。本研究的最终目标是开发并商业化部署一种自动化血液培养系统，该系统可以在实验室收到原始标本后不到24小时内诊断败血症，识别感染生物体的种类和菌株，并确定抗生素敏感性。

DESCRIPTION (provided by applicant): Sepsis is the tenth-leading cause of death in the United States and the second-leading cause of death in the intensive care unit (ICU). Sepsis kills over 215,000 Americans each year - more than breast cancer, lung cancer, and prostate cancer combined. Rapid identification and determination of antibiotic susceptibility is critical fo effective treatment of infected patients. Phase I successfully demonstrated the iSense system's ability to discriminate bacterial species and strain 4-fold faster than legacy methods identify species alone. In Phase I iSense also successfully demonstrated the ability to determine strain-specific susceptibility to antibiotic therapy more than 1 day faster than conventional practice. Phase II aims address application to clinical human specimens along with development of instruments and media appropriate for commercial use. The ultimate goal of this research is to develop and commercially deploy an automated blood culture system that can diagnose sepsis, identify the species and strain of the infecting organism, and determine antibiotic susceptibility all in less than 24 hours from the lab's receipt of primary specimen.