SBIR Phase I: Automated One-Hour Testing for Bacteremia and Antibiotic Sensitivity

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是改善疑似细菌性败血症患者菌血症的早期检测和临床管理。在美国，每年有超过25万名患者死于败血症，导致住院费用超过200亿美元。脓毒症患者的死亡风险已被证明每小时增加4-7%，其中及时给予适当的抗生素有望提高患者的生存率。不幸的是，用于确定抗生素敏感性的标准护理方法需要过夜培养，这可能需要一天或更长时间。目前，在治疗的第一个小时内给予广谱抗生素，希望病原体易感，同时等待抗生素敏感性结果。抗生素耐药性的不断增加严重破坏了标准方法的有效性，因为许多病原体对广谱抗生素的耐药性越来越强。该项目旨在推进一种新的光学方法的开发，用于在1小时内确定抗生素敏感性结果，以支持使用适当的抗生素，这对改善患者死亡率和降低住院费用具有重大潜力。这项小型企业创新研究（SBIR）第一阶段项目涉及一种光学技术，用于快速确定疑似患者血液样本的抗生素敏感性结果。菌血症该产品使用一种用于评估细菌代谢的检测方法，其中可以在有和没有抗生素的情况下培养血液样本，以确定抗生素敏感性。检测和微流体技术的进步使抗生素敏感性结果能够在一小时内交付。这一时间框架将使临床医生能够更早地使用针对患者特定细菌病原体的抗生素，预计这将改善患者的预后。该项目的目标是严格证明该技术的概念验证和可重复性。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve early detection and clinical management of bacteremia in patients suspected of bacterial sepsis. Over 250,000 patients die of sepsis each year in the U.S., which results in hospitalization costs exceeding $20 billion. A sepsis patient’s risk of death has been demonstrated to increase by 4-7% per hour, where timely administration of appropriate antibiotics is expected to improve patient survival. Unfortunately, the standard of care approach for determining antibiotic susceptibility requires overnight culturing that can take a day or more. Currently, broad spectrum antibiotics are administered within the first hour of treatment with the hope that the pathogen will be susceptible, while waiting for antibiotic susceptibility results. The growing landscape of antibiotic resistance severely undermines the efficacy of the standard approach, as many pathogens are increasingly resistant to broad-spectrum antibiotics. This project seeks to advance development of a novel optical approach for determining antibiotic susceptibility results within 1 hour to support the use of appropriate antibiotics, which has significant potential to improve patient mortality outcomes and reduce hospitalization costs.This Small Business Innovation Research (SBIR) Phase I project involves an optical technology for the rapid determination of antibiotic susceptibility results from a blood sample for patients suspected of bacteremia. The product uses an assay for assessment of bacterial metabolism, where a blood specimen may be cultured with and without antibiotics to determine antibiotic susceptibility. Advancements in the assay and microfluidics enable delivery of antibiotic susceptibility results within one hour. This timeframe would enable clinicians to use antibiotics that are targeted to the patient’s specific bacterial pathogen significantly earlier, which is expected to improve patient outcomes. The goal of this project will be to rigorously demonstrate the proof-of-concept and reproducibility of the technology.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.