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

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.