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

SBIR 第一阶段：护理点的诊断前血浆分离

• 批准号: 1938096
• 负责人: Sasank Vemulapati
• 金额: $ 22.5万
• 依托单位: HERMES LIFE SCIENCES LTD
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1938096&HistoricalAwards=false
• 关键词: SBIR; Phase; Pre; diagnostic; Blood

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.

该项目的更广泛的影响/商业潜力将探讨高效快速磁性红细胞分离器（H.E.R.M.M.S），这是一种高度转化的血浆分离系统，实现了商业血液测试的分散化。由于离心的要求，目前血液测试仅限于集中测试实验室，这是大多数诊断测试的关键第一步。但是，离心机不适合在护理点上使用，并且在底面测试的翻译中创建了瓶颈。 H.E.R.M.E.S是一种独特的基于磁珠的分离方法，可快速获得无红细胞的血浆。该技术是一个低成本和独立的平台，有可能提高现有基于血液的诊断测试的测试效率和翻译能力。具体而言，这项工作将研究H.E.R.M.E.S增加人类免疫缺陷病毒（HIV）诊断和病毒载荷定量测试，当时在手指和全血中，与标准实验室和快速诊断测定法一起使用。获得高质量的艾滋病毒测试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 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.该技术将在护理点上增强当前的血液测试能力，并有可能发展高度可靠的诊断测试。 I阶段的工作将证明与商业现有实验室和快速诊断的HIV分析相伴的基础技术可行性。分离测定法的兼容性将通过比较诊断测定的性能与不同样本类型的性能来验证：血液，离心等离子体和H.E.R.R.M.M.E.S血浆。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，以通过提供早期检测来增强HIV诊断测试结果。最终结果是一种可以将血液处理成样本的设备，该设备将增强基于血液的诊断测试的性能。该奖项反映了NSF的法定任务，并且使用基金会的知识分子优点和更广泛的影响审查标准，被认为值得通过评估来提供支持。