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

该项目更广泛的影响/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，能够分散商业血液检测。由于离心分离的要求，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，并且在台架到床边测试的转换中产生了瓶颈。H.E.R.M.E.S是一种独特的磁珠分离方法，可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测试效率和转化能力。具体而言，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检测方法配合使用时，增强手指针刺和全血中人类免疫缺陷病毒（HIV）诊断和病毒载量定量检测的潜力。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本处理技术的问题，并帮助推出下一代强大的床旁血液检测。这个小型企业创新研究（SBIR）第一阶段项目将实现基于磁珠的分离测定，以实现床旁检测环境中低复杂性和快速的血浆分离。该技术将增强目前在护理点的血液检测能力，并有可能开发高度稳健的诊断测试。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检测试剂配套使用的可行性。将通过比较诊断检测试剂盒与不同样本类型（血液、离心血浆和H.E.R.M.E.S血浆）的性能，验证分离检测试剂盒的相容性。该提案将探索使用H.E.R.M.E.S生成的独特样本类型的潜力，通过提供早期检测来提高艾滋病毒诊断检测结果。最终的结果是一个设备，可以处理血液成一个样本，将增强血液为基础的诊断测试的性能。这个奖项反映了NSF的法定使命，并已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。

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.