SBIR Phase I: Hybrid DNA-protein quantification platform for point-of-care diagnosis of syphilis and human immunodeficiency viruses (HIV)

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是创建第一个在护理点提供的一体化自动化梅毒检测。在美国，梅毒病例的数量在过去的5年里翻了一番，从孕妇传给胎儿的先天性梅毒增加了5倍。每年的感染现在占一生医疗费用的1.7亿美元。这种低成本的便携式检测将使医护人员和外联工作能够在一次就诊中立即诊断和治疗患者，以阻止梅毒感染在最脆弱人群中的传播。该平台中的梅毒检测将很容易与人类免疫缺陷病毒（HIV）的混合检测相结合，以简化现有HIV诊断方案中的梅毒检测，并进一步鼓励将该检测方案应用于临床实践。这个小企业创新研究（SBIR）第一阶段项目解决了更简单的梅毒检测解决方案的需求，以便为患者提供全面的现场诊断。梅毒的诊断依赖于两种独立的抗体测试，其中一种需要通过一种称为快速血浆反应（RPR）的繁琐实验室程序来量化抗体水平，以确认患者是否患有活动性感染。缺乏进行现场RPR检测的资源和人员严重限制了公共卫生诊所及时有效诊断梅毒的能力。该项目将两种抗体测试（包括定量RPR）结合到一个自动药筒中，以便在医疗点进行快速和全面的梅毒诊断。本项目提出的研究将为每种抗体测试开发磁颗粒检测方法，并将检测方法整合到多路复用塑料盒中。这些试剂盒与便携式仪器相结合，将使梅毒诊断所需的所有步骤能够在几分钟内以负担得起和易于使用的形式完成。该奖项反映了美国国家科学基金会的法定使命，并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，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the creation of the first all-in-one automated syphilis test available at the point-of-care. The number of syphilis cases in the United States have doubled in the past 5 years with a five-fold increase in congenital syphilis passed from a pregnant mother to the fetus. Annual infections now account for $170 million in lifetime medical costs. This low-cost, portable test will enable care providers and outreach efforts to immediately diagnose and treat patients in a single visit to halt the spread of syphilis infections in the most vulnerable populations. Syphilis testing in this platform will be readily combined with hybrid detection of human immunodeficiency viruses (HIV) to streamline syphilis testing with existing programs for HIV diagnosis and further encourage uptake of this test solution into clinical practice.This Small Business Innovation Research (SBIR) Phase I project addresses the need for easier syphilis testing solutions to provide comprehensive diagnosis on-site with the patient. Syphilis diagnosis relies on two separate antibody tests, of which one requires quantifying antibody levels with a tedious laboratory procedure called Rapid Plasma Reagin (RPR) to confirm if the patient has an active infection. The lack of resources and personnel to conduct RPR testing on-site severely limits the ability of public health clinics to effectively diagnosis syphilis in a timely manner. This project will combine both antibody tests including quantitative RPR into an automated cartridge for rapid and complete syphilis diagnosis at the point-of-care. The research proposed in this project will develop magnetic particle-enabled assays for each antibody test and integrate the assays into a multiplexed plastic cartridge. These cartridges, combined with a portable instrument, will enable all steps required for syphilis diagnosis to be completed within minutes in an affordable and easy-to-use format.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.