Development of a SARS-COV-2 ELISA In Vitro Diagnostic Immuno-Assay

Widespread testing to accurately track the spread of the COVID-19 virus will critically depends on accurate serological tests that can indirectly detect the presence of antibodies produced by the immune system in response to SARS-COV-2\. This approach is intended to identify patients who contracted the virus and have developed immunity against SARS-COV-2\. Most serological (antibody-capture) tests fall into 2 camps: a qualitative Yes/No rapid lateral flow point-of-care tests and a quantitative lab-based ELISA test that relies on accurately measuring the formation of a complex between the antibodies in the patient serum samples and unique structural proteins on the surface of the virus particle. ELISA assays remain a simple yet powerful, robust and trusted tool for the diagnosis of infectious disease.

Current calls for rapid diagnostic (POC) tests does not make the requirement for robust, scalable laboratory-based tests redundant. Laboratory-based tests are the method of choice for large-scale surveillance studies. For example the ELISA is ideal for testing hundreds of samples per day, and is yet versatile to test as few as 1 to 4 tests on the same simple equipment. In addition, POC serological tests have a tendency to be less reliable and less sensitive and therefore there will be an ongoing need for confirmatory testing.

It is clear, that at Kalon, we have a proven and established platform and technical expertise on which to build immunoassays for SARS-CoV2, the virus that causes Covid-19\.