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

小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力是，在妇女健康等重大未得到满足的临床需求领域，更容易获得最先进的分子诊断技术。尿路感染(UTIs)是一个紧迫的问题，因为临床工作流程长，发病率高。尿路感染是美国女性寻求医疗保健最常见的诱因之一，也是抗生素处方的主要驱动力。未经治疗的尿路感染可能会导致患者出现严重的并发症，如全身细菌感染。尽管尿路感染的严重性和流行率很高，但诊断方法仍然非常耗时，依赖过时的基于培养的检测，使妇女在被开出适当的抗生素治疗之前痛苦长达三天。建议的项目将加快尿路感染的诊断，并可用于其他感染。这个小型企业创新研究(SBIR)第一阶段项目将用于细胞浓缩的微流控方法与用于超灵敏检测目标核酸序列的新型纳米结构底物相结合。该读取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。这项技术通过超灵敏的检测方式消除了对细菌培养和核酸放大的需要，在几分钟内提供了物种级别的信息和抗生素耐药性的基因型别数据。这一拟议平台的应用超越了UTI，并在其他临床场景中具有实用价值，这些场景目前采用基于培养的冗长步骤和分子测试工作流程，如呼吸道感染、血液感染和假体关节感染。该项目的目标是通过微流控优化和自动化增加样品产量，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。

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.