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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是显着的。多重耐药微生物（MDRO）或超级细菌（包括沙门氏菌）的流行。金黄色葡萄球菌和耐甲氧西林链球菌。金黄色葡萄球菌（MRSA）是对公共卫生的最大威胁之一。 在美国，每年有超过200万人获得MDRO感染，导致至少23，000人死亡。 此外，MDRO感染已被认为是COVID-19的合并感染，这使得医疗环境中大流行性疾病的治疗变得复杂。 该分析仪将导致快速遏制和快速诊断MRSA和S。金黄色葡萄球菌感染当其容量扩展到包括其他MDRO时，该分析仪将使临床医生能够显着提高治疗效果，从而降低发病率和死亡率，降低治疗和住院费用，降低MDRO的患病率。目前基于培养的细菌感染诊断需要16-48小时才能得出结果。诊断时间长导致广谱抗生素（BSA）的过度使用，导致治疗不足，严重的副作用，发病率和死亡率以及MDRO的发展。免培养分析仪将在120分钟内完成诊断。该分析仪将允许临床医生限制BSA的使用，并在治疗早期开始使用窄谱抗生素，以提高疗效并降低MDRO的患病率。该项目的目标是：（1）构建一个原型分析仪，该分析仪将在120分钟内对多个样本进行同时诊断，以及（2）使用临床样本对原型的临床性能进行小规模表征，以建立其作为临床诊断技术的可信度。原型分析仪将包括一个多通道信号采集电子控制台和检测板。 检测板将包含细菌特异性检测电极阵列，并将插入控制台中，由控制台操作进行测量。该分析仪将检测临床样本中的MRSA，并区分MRSA和S。该奖项反映了NSF的法定使命，并被认为是值得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的支持。

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.