SARS-CoV-2 N-protein for Use in COVID-19 Serological Assays

University of Minnesota Technology Overview
Serology tests to detect SARS-CoV-2 specific antibodies are needed for clinical/surveillance or epidemiological studies in humans and animals. Researchers at the University of Minnesota have successfully expressed and purified full-length nucleocapsid (N) protein of the SARS-CoV-2 for use in serological tests.
Previous assays developed to identify antibodies to the SARS-CoV-2 Spike (S) protein require a glycolyslated S protein produced in mammalian cells. Such production can be slow, labor intensive and expensive. The spike protein is also highly susceptible to accumulating mutations. However, the N-protein is not glycosylated and can be expressed using bacterial systems that are rapid, robust and easy to work with. Furthermore, results indicate that N-protein may in fact produce more sensitive assays than the S protein.
Stage of Development

Technology Readiness Level (TRL): 3-4
Purified N-protein shown to perform in human serological assays to detect previous COVID-19 infection

Benefits

Highly specific and sensitive performance in assays: A serological study of patients with Covid-19 using N-based ELISA found antibodies in 100% of patients at day 5 post hospitalization. The ELISA test was specific to SARS coronaviruses
Rapid and facile protein production: Protein is inexpensive to produce using fast and accessible bacterial expression systems
Validated in serological assays: Purified N protein used in ELISA to detect antibodies against SARS-CoV-2 in human sera from COVID-19 patients (15+ days from symptom onset) showed high signal

Applications

Covid-19 serological assays (human and animal)
Basic Research
Therapeutic development

Opportunity
This technology is now available for:

License
Sponsored research
Co-development

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