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

SBIR 第一阶段：用于梅毒和人类免疫缺陷病毒 (HIV) 即时诊断的混合 DNA-蛋白质定量平台

• 批准号: 2232930
• 负责人: Alexander Trick
• 金额: $ 25.57万
• 依托单位: PROMPT DIAGNOSTICS LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2232930&HistoricalAwards=false
• 关键词: SBIR; Phase; Hybrid; DNA; protein

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.

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全功能一体化自动梅毒检测。在过去的5年里，美国梅毒病例的数量翻了一番，从怀孕母亲传给胎儿的先天性梅毒增加了5倍。现在，每年感染造成的终生医疗费用为1.7亿美元。这种低成本的便携式检测将使护理提供者和外展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，以简化梅毒检测与现有HIV诊断程序，并进一步鼓励将该检测解决方案应用于临床实践。该小型企业创新研究（SBIR）第一阶段项目解决了对更简单的梅毒检测解决方案的需求，为患者提供现场综合诊断。梅毒的诊断依赖于两种单独的抗体检测，其中一种需要通过称为快速血浆反应素（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。缺乏资源和人员进行现场RPR检测，严重限制了公共卫生诊所及时有效诊断梅毒的能力。该项目将联合收割机将两种抗体检测（包括定量RPR）结合到一个自动化检测盒中，以便在护理点进行快速和完整的梅毒诊断。该项目中提出的研究将为每种抗体测试开发磁性粒子启用的测定，并将测定集成到多路复用塑料盒中。这些检测盒与便携式仪器相结合，将使梅毒诊断所需的所有步骤在几分钟内以负担得起的和易于使用的形式完成。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智力价值和更广泛的影响审查标准进行评估的支持。