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

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.