A new enzyme-linked immunosorbent assay (ELISA)-based COVID-19 diagnostic test detects and ranks SARS-CoV-2 neutralizing antibodies by their potency in a simple and relatively short test time.

The test developed internally by AXIM Biotechnologies, Inc. (San Diego, CA, USA) aims to fulfill the need to know the levels of neutralizing antibodies in longitudinal studies of vaccine response in the post-vaccine COVID-19 fight. AXIM’s own reagents and proteins are used in the test kits. The company has completed live SARS-CoV-2 virus microneutralization tests at a Biosafety Level (BSL-3) laboratory with samples from COVID-19 patients to validate diagnostic tests per current Food and Drug Administration (FDA) guidelines. AXIM intends to file its third Emergency Use Authorization (EUA) with the FDA soon.

“From the onset of the pandemic, our scientists have dedicated themselves to creating solutions focused on neutralizing antibody detection. Since no one knows how long vaccines will provide immunity, we continue our development of neutralizing antibody COVID-19 tests,” said AXIM Biotech CEO John W. Huemoeller II. “With the addition of our ELISA-based neutralizing antibody diagnostic test, AXIM hopes to help simplify the testing process for determining a vaccine’s efficacy through clinics across the world.”

“Unlike few currently available ELISA, our uniquely designed assay offers a simple and relatively short test time to detect and rank SARS-CoV-2 neutralizing antibodies by their potency. We believe it will help to evaluate the immune status of patients who recovered from COVID-19 or to monitor immunization efficiency more accurately than other ELISAs,” said AXIM Biotech Chief Technology Officer Alim Seit-Nebi, Ph.D.