SBIR Phase I: Integrated Point-of-Care System for Rapid Pathogen Identification in Urinary Tract Infections

SBIR 第一阶段：用于快速识别尿路感染病原体的集成护理点系统

• 批准号: 2136683
• 负责人: Amogha Tadimety
• 金额: $ 25.59万
• 依托单位: Nanopath Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2136683&HistoricalAwards=false
• 关键词: SBIR; Phase; Integrated; Point; Care

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is improved access to state-of-the-art molecular diagnostic technologies in areas of significant unmet clinical need, such as women’s health. Urinary tract infections (UTIs) are a pressing problem due to the lengthy clinical workflows and large disease incidence. UTIs are one the most common prompts for women to seek health care in the United States and represent a major driver of antibiotic prescriptions. Untreated UTIs can lead to severe complications for the patient, such as systemic bacterial infections. Despite the severity and prevalence of UTIs, diagnostic methodologies remain extremely time-consuming and rely on antiquated culture-based detection, leaving women in pain for up to three days before they are prescribed the appropriate antibiotic therapy. The proposed project will accelerate UTI diagnosis and can be used for other infections as well. This Small Business Innovation Research (SBIR) Phase I project integrates microfluidic methods for cell enrichment with a novel nanostructured substrate for ultrasensitive detection of target nucleic acid sequences. The reader contains software and optical hardware to detect and analyze the test result at the point-of-care. This technology eliminates the need for bacterial culture and nucleic acid amplification through an ultrasensitive detection modality, providing species-level information and genotypic antibiotic resistance data within minutes. The applications of this proposed platform translate beyond UTIs and have utility in other clinical scenarios that currently employ lengthy culture-based steps and molecular testing workflows, such as respiratory infections, bloodstream infections, and prosthetic joint infections. The project goal is to increase sample throughput through microfluidics optimization and automation and to improve sensitivity through novel sensor geometry design.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.

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是改善在重大未满足的临床需求领域（如妇女健康）获得最先进的分子诊断技术的机会。尿路感染（UTI）是一个紧迫的问题，由于漫长的临床工作流程和大的疾病发病率。UTI是美国女性寻求医疗保健的最常见原因之一，也是抗生素处方的主要驱动力。未经治疗的UTI可导致患者的严重并发症，如全身性细菌感染。尽管尿路感染的严重性和流行性，诊断方法仍然非常耗时，并且依赖于过时的基于培养的检测，使妇女在接受适当的抗生素治疗之前疼痛长达三天。拟议的项目将加速UTI诊断，也可用于其他感染。这个小企业创新研究（SBIR）第一阶段项目将用于细胞富集的微流体方法与用于靶核酸序列超灵敏检测的新型纳米结构基底相结合。阅读器包含软件和光学硬件，用于在护理点检测和分析测试结果。该技术通过超灵敏的检测模式消除了对细菌培养和核酸扩增的需要，在几分钟内提供物种水平的信息和基因型抗生素耐药性数据。该平台的应用超越了UTI，并且在目前采用冗长的基于培养的步骤和分子检测工作流程的其他临床场景中具有实用性，例如呼吸道感染，血流感染和假体关节感染。 该项目的目标是通过微流体优化和自动化提高样品通量，并通过新颖的传感器几何设计提高灵敏度。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。