SBIR Phase I: Assessing Risk of COVID-19 Infection with Cell Mediated Immunity

这项小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是一种广泛可用的血液检测，以确定先前未感染者对COVID-19感染的免疫保护水平。多达三分之二的未暴露个体可能由于先前暴露于导致流感样疾病的结构相似的冠状病毒而自然免疫。这一信息对于年老和患有慢性病的弱势群体尤其有用。 抗体仅在接触病毒后出现，并且在不到三分之一的测试个体中观察到。该项目将推进测试，以确定谁可能有这种自然免疫力的个人，可能减轻社会距离的严重性。这个小企业创新研究（SBIR）第一阶段项目将完善申请人的细胞介导免疫力（CMI）的血液测试SARS-CoV-2的广泛使用。初步研究表明，对SARS-COV-2的细胞介导免疫（CMI）可能存在于超过一半的未暴露个体中。该项目将创建方便用户的测试格式，以便使用主要类别的血细胞计数器快速和广泛使用。在这个项目中开发和测试的技术改进将包括固相预制分析，可以在主要类别的参考实验室和便携式细胞仪上读取，以及直接测试未经修改的血液样本的能力。其目标是推进液相分析的标准化试剂盒和预制固相分析管，这些试剂盒和管只需最少的手动步骤，即可用于最常见的基于参考实验室的半便携式和便携式细胞仪，更接近护理点。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值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 a widely available blood test to determine the level of immune protection toward COVID-19 infection in previously uninfected persons. As many as two-thirds of unexposed individuals could be naturally immune due to prior exposure to structurally similar coronaviruses that cause flu-like illness. This information is especially informative for vulnerable populations with advanced age and underlying chronic disease. Antibodies only occur after exposure to the virus, and have been seen in less than one-third of tested individuals. This project will advance tests to identify individuals who potentially have this natural immunity, potentially lessening the severity of social distancing.This Small Business Innovation Research (SBIR) Phase I project will refine the applicant’s blood test for cell-mediated immunity (CMI) to SARS-CoV-2 for widespread use. Preliminary studies suggest that cell-mediated immunity (CMI) to SARS-COV-2 could be present in over half of unexposed individuals. This project will create user-friendly test formats for rapid and widespread use using major classes of cytometers. The technical refinements to be developed and tested in this project will include pre-fabricated assays in solid phase which can be read on major classes of reference-lab-based and portable cytometers, and capabilities for direct testing of unmodified blood samples. The objective is to advance standardized kits for liquid phase assays, and pre-fabricated solid-phase assay tubes with minimal manual steps for use on the most common reference-lab-based, semi-portable and portable cytometers, closer to the point of care.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.