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

小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是开发一个系统，以改进对人类免疫缺陷病毒(HIV)和丙型肝炎病毒(HCV)等传染病的检测。拟议的项目推进了一种低成本、高效率的系统，用于可靠的护理地点血液测试。最终的结果是一种可以将血液处理成样本以改进基于血液的诊断测试的设备。这一小型企业创新研究(SBIR)第二阶段项目将使基于磁珠的分离分析能够在临床环境中以独立于资源的形式实现低复杂性和快速的血浆分离。由于离心法的要求，血液检测目前仅限于集中式检测实验室，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地点使用，是一个瓶颈。这项第二阶段的工作将探索设计和开发一种新的血液采集管，能够在一个外形系数中进行样本采集和样本处理。第二阶段的工作将展示与商业上现有的基于护理点血液的人类免疫缺陷病毒(HIV)和丙型肝炎病毒(HCV)诊断测试配套使用的基础技术的好处。这将通过将磁珠分离分析获得的浓缩血浆与常规离心法进行比较来验证。该奖项反映了NSF的法定使命，并已通过使用基金会的智力优势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 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 comparisonof 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.