SBIR Phase I: Ultra-High Throughput COVID-19 Serology Test Using a Novel Biomarker Multiplexing System

这个小型企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是创建一种快速，廉价和超高通量的测试，以筛选患者对引起COVID-19的SARS-CoV-2病毒的抗体。拟议的测试将促进对先前暴露的人群进行筛查，使流行病学家和政策制定者深入了解病毒的传播和无症状病例的频率。个人将了解他们的风险水平（例如，免疫力强的人可能在短期内不会再次感染），以便作出明智的决定。 所提出的技术将是一种定量测试，可以使免疫水平与疾病严重程度或其他参数相关联。所提出的测试可以很容易地适应同时查询多种抗原，以解决更复杂的医学评估。在当前的大流行之后，这种灵活的技术将在从流行病学到疫苗开发的应用中用于多种病原体和免疫原的暴露测试。这个小型企业创新研究（SBIR）第一阶段项目探索了一种超高通量血清学测试的新方法。 简而言之，将用荧光标记的COVID-19抗原查询患者样本的高密度阵列，以识别具有SARS-CoV-2病毒抗体的患者。对于拟议项目：将优化样品制备和排列（打印）技术和工作流程。将使用加标样本和商业购买的患者血清（商业购买和去识别）优化检测探针（Covid-19抗原）和条件。 将使用抗COVID（50份样本）和非反应性（100份样本）血清测量检测试剂盒的灵敏度和特异性。最后，考虑到SARS-CoV-2病毒与其他冠状病毒有关--其中一些经常在人类中传播，检测探针与针对先前（即，非COVID）感染将被确定。拟议工作的结果将为大规模并行的人群水平血清学筛查提供概念验证。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知识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 create a rapid, inexpensive, and ultra-high throughput test to screen patients for antibodies against the SARS-CoV-2 virus that causes COVID-19. The proposed test will facilitate population-wide screening for prior exposure, giving epidemiologists and policy-makers insight into the virus's spread and the frequency of asymptomatic cases. Individuals will understand their levels of risk (e.g., someone with strong immunity may be protected from re-infection in the near-term) to make informed decisions. The proposed technology will be a quantitative test, which may allow immunity level to be correlated with disease severity or other parameters. The proposed test can be adapted easily to query multiple antigens simultaneously to address more complex medical assessments. Beyond the current pandemic, this flexible technology will be useful for exposure testing for diverse pathogens and immunogens in applications ranging from epidemiology to vaccine development.This Small Business Innovation Research (SBIR) Phase I project explores a novel method for ultra-high throughput serology testing. Briefly, high density arrays of patient samples will be queried with fluorescently labeled COVID-19 antigens to identify patients with antibodies against the SARS-CoV-2 virus. For the proposed project: Sample preparation and arraying (printing) techniques and workflows will be optimized. Assay probes (Covid-19 antigens) and conditions will be optimized using spiked samples and commercially purchased sera from patients, purchased commercially and deidentified. The assay's sensitivity and specificity will be measured using anti-COVID (50 samples) and non-reactive (100 samples) sera. Finally, given that the SARS-CoV-2 virus is related to other coronaviruses––some of which regularly circulate in humans, the potential for assay probes to cross-react with antibodies raised against previous (i.e., non-COVID) infections will be determined. The results of the proposed work will provide proof-of-concept for massively parallel, population-level serology screening.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.