Multiplex serological assays for SARS-CoV-2 infection with implications in diagnostics, vaccine responses, immunity, and prognosis.
- Can be used to identify patients who are at risk of severe disease early in infection.
- Can be used to assess immunity.
- Uses a comprehensive panel of antibodies to test with one sample.
As of December 2020, over 75 million people worldwide been infected and diseased with COVID-19. COVID-19 antibody tests are needed to assess immunity and predicted patient outcome. Many of the existing tests suffer from high error rates and a more specific test is needed.
The inventors multiplex SARS-CoV-2 antigens onto a single assay with detection for antibodies IgG, IgA, and IgM. It can be used to identify patients who are at risk of severe disease early in infection, as these patients have higher antibody levels than mild patients. The inventors demonstrate that critically ill patients display B cell activation and features observed in autoimmune diseases. Certain B cell activation strongly correlated with early production of high levels of SARS-CoV-2 specific neutralizing antibodies very early in illness. The inventors obtained and clustered flow cytometry data and could separate severely and critically ill inpatients (ICU-C) from mildly ill outpatients (OUT-C) driven by a coordinated increase in specific B cell populations. These unique B cell subsets correlated with higher serum antibody responses against the SARS-CoV-2 spike protein in the severe group early in disease. These results suggest use as a prognostic serological assay for COVID-19 severity or immunity information. These multiplex antigenic and isotype platforms can be used to distinguish patients with history of SARS-CoV-2 infection vs. COVID-19 vaccine administration.
- Serological assay validated in >100 COVID-19-positive patients, measured against pre-pandemic controls.
- Ongoing work to improve accuracy of assay with additional patient samples.
- Seeking industry partner to assist with emergency use authorization with FDA.