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

这个小企业创新研究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(如新冠肺炎)产生不良且往往是致命的反应的风险。该项目提出了一种快速准确的新冠肺炎感染严重程度检测方法。建议的检测方法有可能实现早期干预并拯救生命。这项小型企业创新研究(SBIR)第一阶段项目将产生一种新技术，能够诊断任何传染病(如SARS-CoV-2、登革热、流感、丙型肝炎等)的免疫反应失调。这是通过抗体依赖增强(ADE)机制进行的。虽然感染SARS-CoV-2病毒最初是一种轻微的疾病，但一些患者的健康状况会突然迅速下降，原因是促炎细胞因子的大量释放，即“细胞因子风暴”，细胞因子风暴会导致肺部过度炎症，从而导致急性呼吸窘迫综合征，这是新冠肺炎死亡的主要原因。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一种高度多元化、快速、灵敏、一次性的针对新冠肺炎感染的免疫分析方法来填补这一医疗技术空白，并将其大规模部署。这项工作将包括设计、构建和优化基于纳米孔技术创新的免疫分析原型，并针对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 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.