I-Corps: Rapid Susceptibility Assay for Antibiotic Resistance

该I-Corps项目更广泛的影响/商业潜力是开发一种无需仪器的比色床旁诊断，能够在护理时检测尿路感染（UTI）患者的抗生素耐药性。目前，没有诊断选项可以在护理时为医生提供耐药性信息。传统的微生物学技术需要三天时间才能得出结果，因此医生必须凭经验开出抗生素治疗处方。通过快速检测抗生素耐药性，可以在护理时开出正确的抗生素类别。在短期内，这可以更好地为患者提供护理，患者可以接受最低代和最广谱的抗生素，这意味着潜在的副作用更少。此外，对于那些表现出更高级别耐药性的患者，可以使用最后手段的抗生素，以确保在第一个疗程的抗生素治疗中清除感染。这个I-Corps项目基于专利核心技术，可以快速检测尿液样本中的b-内酰胺耐药菌，而不需要目前临床工作流程中所需的样本处理或细菌培养步骤。该生化检测通过使用独特的扩增策略直接检测负责抗性的酶。该扩增技术基于一种创新的酶依赖性扩增级联，与传统的分子诊断探针配对以增加信号，从而无需复杂的仪器即可检测低丰度生物标志物。最终，颜色变化表明存在对b-内酰胺抗生素耐药的细菌。该技术将结果生成时间缩短至30分钟，而传统微生物分析需要3天。

The broader impact/commercial potential of this I-Corps project is the development of an instrument-free colorimetric point-of-care diagnostic capable of detecting antibiotic resistance in patients with urinary tract infections (UTIs) at time of care. Currently, there are no diagnostic options that can provide doctors with resistance information at time of care. Traditional microbiology techniques take three days to deliver results, so doctors must prescribe antibiotic treatments empirically. By rapidly detecting antibiotic resistance, the correct class of antibiotic can be prescribed at time of care. In the short-term, this enables better patient care where the patient can receive the lowest generation and narrowest spectrum antibiotic that is appropriate, meaning fewer potential side effects. Further, for those patients who exhibit higher-order resistance, last-resort antibiotics can be employed to ensure that the infection is cleared during the first course of antibiotics.This I-Corps project is based on patented core technology that enables rapid detection of b-lactam resistant bacteria in urine samples without the need of sample processing or bacterial culturing steps that are currently required in the clinical workflow. This biochemical assay directly detects the enzyme responsible for resistance by using a unique amplification strategy. The amplification technology is based on an innovative enzyme-dependent amplification cascade that is paired to traditional molecular diagnostic probes to create an increase in signal, allowing for detection of low abundant biomarkers without the need of sophisticated instrumentation. Ultimately, a color change indicates the presence of bacteria resistant to b-lactam antibiotics. This technology reduces time-to-results to just 30 minutes, compared to 3 days with traditional microbiology analysis.