First-in-Class Rapid Diagnostic Test Measures COVID-19 Neutralizing Antibodies in Plasma and Serum

A new rapid diagnostic test is expected to be the market’s first COVID-19 rapid diagnostic test for measuring the levels of functional SARS-CoV-2 neutralizing antibodies in a lateral flow assay format.

AXIM Biotechnologies, Inc. (San Diego, CA, USA) has filed an Emergency Use Authorization (EUA) application with the Food and Drug Administration (FDA) for measuring COVID-19 neutralizing antibodies in plasma and serum through its first-in-class rapid diagnostic test. Neutralizing antibodies prevent SARS-CoV-2, the virus responsible for the current COVID-19 pandemic, from binding to and entering host cells.

The lateral flow assays will be manufactured under the name Tru-19 Neutralizing Antibody Test (Tru-19). With the filing of this EUA, AXIM is now able to begin selling Tru-19 to clinics immediately. Tru-19 is unlike other rapid serological COVID-19 tests currently on the market because it measures levels of neutralizing antibodies in serum or plasma from patients that have recovered from COVID-19. With this knowledge, plasma with the highest levels of neutralizing antibodies can be identified and administered to patients fighting COVID-19. Since the Tru-19 test agrees with virus-based assays, it could be a tool for monitoring levels of neutralizing antibodies in large numbers of vaccine recipients.