SBIR Phase I: Early Diagnosis of the COVID-19 Cytokine Storm via Point-of-Care Antibody Profiling

这个小型企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是预测患者对某些病毒感染（如COVID-19）产生不利且通常致命反应的风险。该项目提出了一种快速准确的检测COVID-19感染严重程度的方法。 所提出的检测方法有可能实现早期干预并挽救生命。它可能用于COVID-19以外的许多其他感染和公共卫生危害。这个小企业创新研究（SBIR）第一阶段项目将产生一种新技术，能够诊断任何传染病的免疫反应失调（例如，SARS-CoV-2、登革热、流感、丙型肝炎等）通过抗体依赖性增强（ADE）机制进展。虽然SARS-CoV-2病毒的感染开始时是一种轻微的疾病，但一些患者的健康状况会突然迅速下降，这是由于大量释放促炎细胞因子所致，即，一种“细胞因子风暴”，细胞因子风暴导致肺部过度炎症，从而导致急性呼吸窘迫综合征（ARDS），这是COVID-19死亡的主要原因。不幸的是，目前还没有能够预测这一事件的测试。该项目旨在通过开发针对COVID-19感染的高度多重、快速、灵敏、一次性免疫测定来填补这一医疗技术空白，并将大规模部署。这项工作将包括设计、构建和优化基于纳米孔技术创新的原型免疫分析，并根据行业标准对开发的技术进行分析验证。该奖项反映了NSF的法定使命，并被认为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来支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to predict a patient’s risk for developing an adverse and often lethal response to certain viral infections, such as COVID-19. This project proposes a fast and accurate test for the severity of COVID-19 infection. The proposed assay has the potential to enable early intervention and save lives. It can potentially be used for many other infections and public health hazards beyond COVID-19.This Small Business Innovation Research (SBIR) Phase I project will produce a new technology capable of diagnosing immune response dysregulation to any infectious disease (e.g., SARS-CoV-2, dengue, influenza, hepatitis C, etc.) that progress through an antibody dependent enhancement (ADE) mechanism. While infection by the SARS-CoV-2 virus begins as a mild illness, some patients experience a sudden and rapid decline in health, precipitated by a massive release of pro-inflammatory cytokines, i.e., a “cytokine storm,” Cytokine storms cause hyperinflammation of the lungs, which leads to acute respiratory distress syndrome (ARDS), the leading cause of COVID-19 mortality. Unfortunately, there is presently no test capable of predicting this event. This project aims to fill this medical technology gap via the development of a highly multiplexed, rapid, sensitive, disposable immunoassay specific to COVID-19 infections to be deployed at scale. The effort will include designing, building, and optimizing a prototype immunoassay based on nanopore technology innovations and analytically validating the developed technology against industry standards.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.