SBIR Phase I: A near real-time analyzer for MRSA screening and diagnosis of MRSA infections

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project are significant. The prevalence of multi-drug resistant organisms (MDROs) or superbugs, which include S. aureus and methicillin-resistant S. aureus (MRSA), is one of the greatest threats to public health. Annually in the United States, over 2 million people acquire MDRO infections, leading to at least 23,000 deaths. Further, MDRO infections has been recognized as co-infections of COVID-19 that complicates the therapeutics of the pandemic disease in the healthcare environment. The analyzer will lead to fast containment and rapid diagnosis of MRSA and S. aureus infections. When its capacity is expanded to include other MDROs, the analyzer will allow clinicians to significantly enhanced treatment efficacy, leading to decreased morbidity and mortality, reduced costs of treatment and hospital stay, reduced prevalence of MDROs. This Small Business Innovation Research Phase I project will address the long time-to-result of current MRSA testing technologies. The current culture-based diagnosis of bacterial infections requires 16-48 hours to produce results. The long diagnosis-time leads to overuse of broad-spectrum antibiotics (BSAs), resulting in under-treatment, severe side effects, morbidity and mortality as well as the development of MDROs. The culture-free analyzer will complete the diagnosis in 120 minutes. The analyzer will allow clinicians to limit the use of BSAs and start using narrow spectrum antibiotics in the early stage of treatment to enhance efficacy and reduce the prevalence of MDROs. The goals of the project are: (1) To construct a prototype analyzer, which will provide simultaneous diagnosis on multiple samples in 120 minutes, and (2) To conduct a small-scale characterization of the clinical performance of the prototype with clinical samples to establish its credibility as a clinical diagnostic technology. The prototype analyzer will consist of a multi-channel signal acquisition electronics console and detection plates. The detection plate will contain an array of bacteria-specific detection electrodes and will be inserted into the console and operated by the console for measurements. The analyzer will detect MRSA in clinical samples and distinguish MRSA from S. aureus. 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.