Rapid, Specific and Sensitive Point of Care Antibody Testing for SARS-CoV-2 (COVID-19)

Background

As COVID-19 continues to rage on around the world, there is an urgent need for a simple, yet accurate antibody test to identify infected individuals in large scales to inform health decisions. Development of a rapid, accurate and specific point-of-care COVID-19 antibody test for use at community level remains an utmost priority.

To date, nearly 50 antibody test, enzyme-linked immunosorbent assay (ELISA) have been approved for emergency use in the US, yet they ether have low specificity or low sensitivity to detect SARS-CoV2 antibodies. Additionally, ELISA-based antibody tests, which can be qualitative or quantitative, require specialized instruments and are usually performed in a lab by a trained technologist. To enable point-of-care testing, several rapid diagnostic tests (RDTs) based on lateral flow have been developed. Although the RDTs reduced the time of the test from 2-5 hours (for ELISA) to 10-30 minutes, they generally suffer from decreased sensitivity and specificity compared to ELISA-based tests

Furthermore, as vaccinations are carried out in large scales, vaccine effectiveness must be measured by antibody response to determine immunity. Therefore, there is an urgent need to develop highly specific, rapid and accurate SARS-CoV-2 point of care antibody test that can be implemented at the community level.

Technology Overview

Researchers at Western University have developed a rapid, accurate, specific and economic point-of-care SARS-CoV-2 antibody agglutination test (using Latex beads or Red blood cells) suitable for use at the community level. When validated using plasma and blood samples that are positive or negative for the new coronavirus, the agglutination assay detected antibodies against the receptor-binding domain of the spike (S-RBD) or the nucleocapsid (N) protein of SARS-CoV-2 with 100% specificity and >98% sensitivity. Furthermore, using proprietary technology allows the current system to be specific and cost-effective.

Antibody testing can alter the course of the COVID-19 pandemic by allowing point of care diagnosis, assessing penetrance, and facilitating treatment of infected individuals by passive immunization. This serologic test, which is based on antibody-dependent agglutination of antigen-coated latex particles (Figure 1), takes 5 ul plasma and <5 min to complete with no instrument required. This invention has potential commercial values as it addresses the pressing need for a simple, cost-effective and rapid yet accurate antibody test

Benefits

• Rapid, specific and accurate point of care antibody test for SARS-CoV-2 to determine immune response
• Test results in <5 minutes with 100% specificity and greater than 98% sensitivity
• Small sample volume, can be done with blood or plasma
• Capability for high throughput screening
• Agglutination can be quantified to determine antibody response
• Highly economical

Applications

• Rapid, specific and accurate point of care antibody test for SARS-CoV-2 to determine immune response
• Can be expanded to other viruses and infectious disease immune response
• Validation of vaccination and immune response

Opportunity

• US Provisional Patent filed
• Industry Partnerships
• Licensing
• Product Development

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