- The Washington Times - Friday, April 3, 2020

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.

The FDA emergency-use authorization came at the request of the biotech company Cellex, which has two offices in China and its U.S. headquarters in Research Triangle Park, North Carolina.

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.

Results may be determined 15-20 minutes after beginning the test, which gives a positive result by showing colored bands for both antibodies as well as a control. While IgM antibodies are detectable “several days after initial infection, IgG antibodies become detectable “later following infection,” according to the FDA letter.

The test differs from those used to determine whether a patient has an active case of COVID-19.

Antibody testing is already underway in countries such as China and Singapore. In San Miguel County, Colorado, the town has offered to test any resident for coronavirus antibodies using the ELISA blood test, the Telluride Daily Planet reported.

Dr. Peter Antevy tested himself for COVID-19 antibodies after becoming sick in January with a “flu-like illness.” His first test result, which he posted Thursday on Twitter, was positive.

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