SBIR Phase II: Blood-Plasma Separation for Point-of-Care Diagnostic Testing

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the development of a system to improve detection of infectious diseases, such as Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). The proposed project advances a low-cost, efficient system for robust point-of-care blood tests. The end result is a device that can process blood into a sample for improved blood-based diagnostic testing. This Small Business Innovation Research (SBIR) Phase II project will enable a magnetic-bead based separation assay to achieve low-complexity and rapid blood-plasma separation in a resource-independent form factor for clinical settings. Blood testing is currently limited to centralized testing labs due to the requirements of centrifugation, a key first step in most diagnostic testing. However, centrifuges are not suitable for use at the point-of-care and represent a bottleneck. This Phase II effort will explore the design and development of a new kind of blood collection tube capable of performing sample collection and sample processing in one form factor. The Phase II effort will demonstrate the benefit of the underlying technology for companion use with commercially existing point-of-care blood-based diagnostic tests for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). This will be validated by comparison of enriched plasma obtained with the magnetic bead separation assay with a conventional centrifugation process. 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.