Was it flu or the coronavirus? FDA authorizes first COVID-19 antibody test
That raspy cough, chest tightness and fever you battled last month — was that just a bug? Or were you infected with the novel coronavirus?
The U.S. Food and Drug Administration just made it easier to find out. The agency has issued its first emergency-use authorization for a rapid blood test to detect antibodies against COVID-19, the disease caused by the novel coronavirus, circulating in the bloodstream of those who have recovered from the illness.
Identifying the antibodies associated with SARS-CoV-2, the new coronavirus, is important in helping public-health officials determine how widely the virus has spread and identify who has developed an immune response, as well as aid scientists in creating a vaccine.
In her Wednesday letter to Cellex CEO James X. Li, FDA chief scientist Denise M. Hinton said that she has concluded that the “known and potential benefits of your authorized product … outweigh the known and potential risks of your product.”
The test, which can only be analyzed in authorized labs, is aimed at detecting two antibodies — immunoglobulin M [IgM] and immunoglobulin G [IgG]—both produced in reaction to the novel coronavirus.