SBIR Phase I: Rapid Antibiotic Susceptibility Testing of Sexually Transmitted Infections

这项小企业创新研究（SBIR）第一阶段项目建议开发一种新的检测方法，在护理点近乎实时地诊断引起性传播感染的病原微生物。该技术方法是基于阻抗传感的一种新实现来监测细菌生长，具有卓越的灵敏度和稳定性，并结合了一种成熟的免疫捕获技术。该方法避免了对培养物的需要，并且能够在几个小时内通过简单易用的低成本设备直接从临床样品中获得鉴定和抗生素敏感性，非常适合大规模生产。与目前使用的方法相比，该技术的实施将缩短从样品收集到完成感染性病原体诊断的时间，并使处方靶向抗生素治疗成为可能。拟议的诊断工具的可行性将在为期6个月的第一阶段工作中首先用淋病奈瑟菌来证明，并且很容易适用于其他性传播感染（STI）生物体。如果取得成功，该项目将使快速确定与性传播感染有关的病原体的抗生素敏感性的实用和负担得起的方法更加容易获得，从而对公共卫生产生重大影响，使有效政策得到更好的管理。没有常规进行性传播感染的抗生素敏感性检测，部分原因是抗生素耐药性检测耗时。提供一种可在医疗点进行的快速和负担得起的诊断检测将改善患者的治疗效果，使其能够开出靶向抗生素治疗的处方，并减少抗生素耐药性的传播。

This Small Business Innovation Research (SBIR) Phase I project proposes the development of a new test to diagnose pathogenic microorganisms causing sexually transmitted infections at the point-of-care in near-real time. The technical approach is based on a novel implementation of impedance sensing to monitor bacterial growth with exceptional sensitivity and stability combined with a well-established immuno-capture technique. The method avoids the need for grown cultures and enables both identification and antibiotic susceptibility to be obtained directly from clinical samples within a few hours with a simple and easy-to-use low cost device ideally suited for mass production. Implementation of the proposed technology will reduce the time from sample collection to complete diagnosis of infectious agent by days compared to currently used methods and enable the prescription of targeted antibiotic therapies. Feasibility of the proposed diagnostic tool will be demonstrated initially with the organism Neisseria gonorrhoeae within a 6-month Phase I effort and is readily applicable to other sexually transmitted infections (STI) organisms. If successful this project will make a practical and affordable method for rapidly determining the antibiotic susceptibility of pathogens associated with STI more available therefore having significant impact on public health allowing better management of effective policies. Antibiotic susceptibility testing of STI is not routinely performed, in part, because of the time consuming nature of testing for antibiotic resistance. The availability of a rapid and affordable diagnostic test that could be performed at the point-of-care would improve patient outcomes enabling the prescription of targeted antibiotic therapies and reducing the spread of antibiotic resistance.