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

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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.