SBIR Phase I: Rapid detection of blood-borne bacteria and determination of antibiotic resistance

SBIR 第一阶段：快速检测血源性细菌并确定抗生素耐药性

• 批准号: 2136428
• 负责人: Mustafa Al-Adhami
• 金额: $ 25.6万
• 依托单位: ASTEK DIAGNOSTICS LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-15 至 2022-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2136428&HistoricalAwards=false
• 关键词: SBIR; Phase; Rapid; detection; blood

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to speed up the diagnosis of bacteremia, the root cause of bacterial sepsis, a life-threatening condition wherein the body’s response to an infection injures its tissues and organs. Each hour of delay in administering an effective antibiotic is associated with an estimated 7.6% increase in mortality. This project can impact the treatment and currently expensive care of 1.7 million US patients (49 million worldwide) annually. Poorly suited antibiotics contribute to roughly 270,000 sepsis deaths each year in the United States. This project will advance a rapid (1 hour) identification of antibiotic susceptibility to enable switching from broad-spectrum antibiotic treatment to targeting the specific organism causing sepsis. This Small Business Innovation Research Phase-I project explores the feasibility of a fluorescence system to detect bacterial metabolic activity and determine antibiotic susceptibility in an hour, with the goal of achieving high sensitivity and specificity while lowering false positive or negative rates common in early results This project will advance the technology in three critical areas: (1) designing a disposable test cartridge that integrates the separation of bacteria from whole blood and introduction of fluorescent dye; (2) limiting background fluorescence to increase result accuracy; and (3) developing software that provides users with easily interpreted results and reliable process control.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这一小企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力是加快菌血症的诊断，菌血症是细菌败血症的根本原因，细菌败血症是一种威胁生命的疾病，身体对感染的反应会损害其组织和器官。有效抗生素的使用每延迟一小时，死亡率估计就会增加7.6%。该项目可能会影响每年170万美国患者(全球4900万人)的治疗和目前昂贵的护理。在美国，不合适的抗生素每年导致大约27万人死于脓毒症。该项目将推进抗生素敏感性的快速(1小时)鉴定，使之能够从广谱抗生素治疗切换到针对导致败血症的特定微生物。这个小型企业创新研究第一阶段项目探索了荧光系统在一小时内检测细菌代谢活动和确定抗生素敏感性的可行性，目的是在降低早期结果中常见的假阳性或假阴性率的同时实现高灵敏度和特异度。该项目将在三个关键领域推进这项技术：(1)设计一种一次性测试盒，将细菌从全血中分离并引入荧光染料；(2)限制背景荧光以提高结果的准确性；以及(3)开发为用户提供易于解释的结果和可靠的过程控制的软件。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。