SBIR Phase I: Point-of-Care Diagnostic Tool for Identifying Extended Spectrum β-Lactamase E. Coli in Urinary Tract Infection

这一小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力在于展示了一种基于新技术的护理点诊断设备对尿路感染患者的商业可行性和临床好处。在美国，每年有1000万人次因尿路感染而接受初级保健。在这些患者中，超过15%的人患有抗药性感染。临床研究表明，准确识别和早期诊断感染细菌的耐药性，可以缩短治疗周期，消除抗生素滥用，降低患者平均费用。然而，返回有关细菌身份和抗生素耐药性的分子信息的现场诊断测试仍然是一个重大挑战。目前以实验室为基础的测试成本高昂，周转时间长，需要熟练的技术人员和设备齐全的实验室。在大多数情况下，在检测结果返回信息之前，这会导致经验抗生素处方。开发快速、现场、易于实施和经常使用的抗菌素耐药性筛查对于抗击抗菌素耐药性和抗生素滥用的持续威胁至关重要。该设备将适用于门诊、家庭保健和住院设施。这将使细菌感染的治疗从经验转向循证。这项小型企业创新研究第一阶段项目将开发一种现场鉴定设备，用于现场鉴定来自未经处理的尿样的尿路感染中的大肠杆菌和相关的超广谱β-内酰胺酶耐药基因。该设备使用新颖的、正在申请专利的电化学核酸传感技术和环介导的等温扩增分析来半定量测量目标细菌基因。该装置由一次性微流控芯片和便携式多功能阅读器组成。自含式微流控感应盒支持样品制备、等温放大和特定序列的电化学检测。传感技术和高度集成的样品处理微流体的这种新颖组合将使迫切需要的护理点诊断解决方案的开发成为可能。该项目将展示细菌检测的特异性、识别多种基因类型的能力、设备操作的简便性以及这种护理点设备的便携性。该奖项反映了NSF的法定使命，并已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 lies in demonstrating the commercial viability and clinical benefit of a point-of-care diagnostics device based on novel technologies for patients with urinary tract infections. There are 10 million primary care visits for urinary tract infections per year in the United States. More than 15% of these patients suffer antibiotic-resistant infections. Clinical studies have shown that accurate identification and early diagnosis of the antibiotic resistance of the infecting bacteria shorten the treatment period, eliminate antibiotic misuse, and reduce average patient costs. However, on-site diagnostic testing that returns molecular information about the bacterial identity and antibiotic resistance remains a significant challenge. Current laboratory-based tests are costly, have long turnaround times, and require skilled technicians and well-equipped laboratories. In most cases, this results in empirical antibiotic prescriptions before the information is returned from test results. Developing rapid, on-site, easy-to-implement, and frequently used antimicrobial resistance screening is essential to combat the ongoing threat of antimicrobial resistance and antibiotic misuse. This device will be suitable for outpatient clinics, home healthcare, and inpatient facilities. It will enable a shift from empirical to evidence-based treatment of bacterial infections.This Small Business Innovation Research (SBIR) Phase I project will develop a point-of-care device for the on-site identification of E. coli and associated extended-spectrum β-lactamase (ESBL) antibiotic resistance genes in urinary tract infections from unprocessed urine samples. The device uses novel, patent-pending electrochemical nucleic acid sensing techniques and a loop-mediated isothermal amplification assay to semi-quantitatively measure target bacterial genes. The device consists of a disposable microfluidic cartridge and a portable multifunctional reader. The self-contained microfluidic sensing cartridge supports sample preparation, isothermal amplification, and sequence-specific electrochemical detection. This novel combination of sensing technology and highly integrated sample handling microfluidics will enable the development of critically needed point-of-care diagnostic solutions. The project will demonstrate the specificity of bacterial detection, the ability to identify multiple genotypes, the ease of device operation, and the portability of this point-of-care device.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.