KEY POINTS

  • The FDA sent an emergency use authorization letter to Cellex Inc., the developer of the test
  • The test must be performed by an authorized laboratory and involves a blood draw
  • The FDA said the public health emergency benefits outweigh the known potential risks of the test

The Food and Drug Administration on Thursday authorized its first emergency use coronavirus serology test, opening the way for a possible treatment for COVID-19, which has infected some 1 million worldwide and killed more than 51,000. The test will determine if a person has been infected.

The test was developed by Cellex Inc. and involves a blood draw done at a certified lab. It can provide results in 15 minutes.

“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19,” FDA chief scientist Denise M. Hinton said in a letter to Cellex CEO James X. Li.

“The known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product.”

The test will determine whether an individual has developed antibodies to the virus, which would be detectable within days of initial infection, and will be used on people who are suspected of having the virus. The Centers for Disease Control and Prevention is developing its own test, which could be used for people with mild or no symptoms.

Becton, Dickinson and Co. and BioMedomics earlier this week announced a similar antibody test but has yet to receive the FDA’s emergency approval.

Antibody testing differs from the testing being done to determine whether individuals are suffering from coronavirus, which involve nasal swabs.

Presence of antibodies could open the way for the use of convalescent plasma although the process is expensive, and it was unclear whether it was a viable treatment.

Plasma is the liquid that’s left once blood cells are removed. Plasma from people who have recovered from the virus could be given to sick patients to help them fight off the disease. Doctors in New York and Houston began plasma treatments during the weekend, USA Today reported.

Preliminary research from China published by JAMA indicates convalescent plasma helped five critically ill COVID-19 patients recover.

“These preliminary findings raise the possibility that convalescent plasma transfusion may be helpful in the treatment of critically ill patients with COVID-19 and ARDS, but this approach requires evaluation in randomized clinical trials,” the Chinese researchers said.

Scientists have found eight strains of the coronavirus circulating.

By midafternoon Thursday, the U.S. had recorded 234,462 confirmed coronavirus infections with 5,607 deaths.

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