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、廉价和超高通量的检测方法，用于筛查患者是否有针对导致新冠肺炎的SARS-CoV-2病毒的抗体。拟议的检测将有助于在全人群范围内筛查先前接触过的病毒，使流行病学家和政策制定者能够洞察病毒的传播和无症状病例的频率。个人将了解自己的风险水平(例如，免疫力较强的人可能会在短期内免受再次感染)，以便做出明智的决定。这项拟议的技术将是一种定量测试，它可能允许免疫水平与疾病严重程度或其他参数相关。建议的测试可以很容易地调整为同时查询多个抗原，以处理更复杂的医学评估。除了目前的大流行，这项灵活的技术将有助于对从流行病学到疫苗开发等应用中的各种病原体和免疫原进行暴露测试。这项小型企业创新研究(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，将用荧光标记的新冠肺炎抗原查询高密度患者样本阵列，以识别对SARS-CoV-2病毒有抗体的患者。对于拟议的项目：将优化样品制备和排列(印刷)技术和工作流程。分析探针(新冠肺炎抗原)和条件将使用添加的样本和从患者那里商业购买的血清进行优化，商业购买和鉴定。该检测的敏感性和特异性将使用抗COVID(50个样本)和非反应性(100个样本)血清来衡量。最后，鉴于SARS-CoV-2病毒与其他冠状病毒有关，其中一些冠状病毒经常在人类中传播，因此将确定检测探针与针对以前(即非冠状病毒感染)感染的抗体发生交叉反应的可能性。拟议工作的结果将为大规模平行的、人口水平的血清学筛查提供概念验证。这一奖项反映了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 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.