SBIR Phase I: Pre-diagnostic Blood-Plasma Separation at the Point-of-Care

该项目的更广泛影响/商业潜力将探索开发高效快速磁性红细胞分离器（H.E.R.M.E.S），这是一种高度转化的血浆分离系统，使商业血液检测分散化。由于离心机的要求，血液检测目前仅限于集中检测实验室，这是大多数诊断检测的关键第一步。然而，离心机不适合在护理点使用，并且在从工作台到床边测试的转换中造成了瓶颈。H.E.R.M.E.S是一种独特的基于磁珠的分离方法，可以快速获得不含红细胞的血浆。该技术是一种低成本的独立平台，有可能提高现有血液诊断测试的检测效率和转化能力。具体来说，这项工作将研究H.E.R.M.E.S在与标准实验室和快速诊断分析一起使用时，在手指棒和全血中增强人类免疫缺陷病毒（HIV）诊断和病毒载量定量测试的潜力。获得更高质量的艾滋病毒检测将对公共卫生和改善诊断结果产生重大影响。H.E.R.M.E.S将解决缺乏低成本和高效的样品处理技术的问题，并帮助引入下一代强大的即时血液检测。这项小型企业创新研究（SBIR）第一阶段项目将实现基于磁珠的分离分析，以在即时检测环境中实现低复杂性和快速的血浆分离。该技术将增强目前在医疗点的血液检测能力，并有可能开发出高度可靠的诊断测试。第一阶段的工作将证明基础技术与商业上现有的基于实验室的快速诊断HIV检测方法配套使用的可行性。将通过比较诊断分析与不同样品类型（血液、离心血浆和H.E.R.M.E.S血浆）的性能来验证分离分析的兼容性。该提案将探索利用H.E.R.M.E.S产生的独特样本类型的潜力，通过提供早期检测来提高HIV诊断测试结果。最终的结果是一种可以将血液处理成样本的设备，这将增强基于血液的诊断测试的性能。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 project will explore the development the High Efficiency Rapid Magnetic Erythrocyte Separator (H.E.R.M.E.S), a highly translational blood-plasma separation system enabling the decentralization of commercial blood testing. Blood testing is currently limited to centralized testing labs due to the requirements of centrifugation, a key first step in the majority of diagnostic testing. However, centrifuges are not suitable for use at the point-of-care and have created a bottleneck in the translation of bench-to-bedside testing. H.E.R.M.E.S is a unique magnetic bead-based separation method to quickly obtain plasma free of red blood cells. The technology is a low-cost and standalone platform with the potential to augment the testing efficiency and translational ability of existing blood-based diagnostic tests. Specifically, this effort will examine the potential for H.E.R.M.E.S to augment Human Immunodeficiency Virus (HIV) diagnostic and viral load quantification testing in finger-stick and whole blood, when used with standard lab-based and rapid diagnostic assays. Access to higher quality HIV tests will have a major impact for public health and improved diagnostic outcomes. H.E.R.M.E.S will address the lack of availability of low-cost and efficient sample processing technologies and help introduce the next generation of robust point-of-care blood tests.This Small Business Innovation Research (SBIR) Phase I project will enable the implementation of a magnetic-bead based separation assay to achieve low-complexity and rapid blood-plasma separation in point-of-care testing environments. The technology will enhance current blood-testing capabilities at the point-of-care and has the potential to enable the development of highly robust diagnostic tests. This Phase I effort will demonstrate the feasibility of the underlying technology for companion use with commercially existing laboratory-based and rapid diagnostic HIV assays. The compatibility of the separation assay will be verified by comparing the performance of the diagnostic assay with different sample types: blood, centrifuged plasma and H.E.R.M.E.S plasma. This proposal will explore the potential to use the unique sample type generated by H.E.R.M.E.S to enhance HIV diagnostic testing outcomes by providing earlier detection. The end result is a device that can process blood into a sample that will augment the performance of blood-based diagnostic testing.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.