Beckman Coulter announced this week that its Access SARS-CoV-2 IgG antibody assay received CE Mark approval and is commercially available in Europe.
Brea, Calif.-based Beckman Coulter said in a news release that it already shipped tests to more than 400 hospitals, clinics and diagnostic laboratories in the U.S. and has begun to ship around the globe. It already has more than 16,000 immunoassay analyzers worldwide and ramped up its manufacturing to deliver more than 30 tests per month.
The Access SARS-CoV-2 IgG assay detects immunoglobulin G (IgG) and targets antibodies that recognize the receptor-binding domain (RBD) of the spike protein when testing for the virus causing COVID-19. The company will be seeking CE Mark approval for its Access SARS-CoV-2 IgM assay in the near future as well.
“Our assay has the potential to identify individuals who have already mounted an immune response to the novel coronavirus and could donate convalescent plasma for use in combatting the disease in seriously ill patients,” Beckman Coulter president Julie Sawyer Montgomery said in the news release. “Convalescent plasma therapy will be a critical tool in our treatment arsenal in the absence of an effective vaccine as we look toward the fall and winter when many epidemiologists anticipate a second large wave of infections.”
According to a report in 360dx, a spokesperson for Beckman Coulter said the company also submitted the test for FDA emergency use authorization (EUA) and is expecting the decision soon.