FDA COVID-19 antibody tests are pulled from approval

Jun 17, 2020, 7:52 PM
FDA COVID-19 Antibody Tests...
(Picture Credit: Getty Images)
(Picture Credit: Getty Images)

BLUFFDALE, Utah – The FDA has pulled approval of the COVID-19 antibody tests. The decision comes shortly after thousands of Utahns jammed into parking lots in last month to test themselves for COVID-19 antibodies.

It may have been all for nothing.

On Wednesday, the Food and Drug Administration pulled it’s emergency approval of the Chembio Diagnostic System because it was producing a higher than average number of false results. 

Dr. Paul Benson with RapidSolutions, the Utah company who administered the test, said it’s not uncommon for the FDA to pull their approval as quickly as they grant it, but he does not believe anyone had an inaccurate result. 

Even so, Benson says they will be looking at other alternatives. 

“Having one specific test pulled from use means that we simply need to put a little bit more thorough investigation into the other tests we’ve been looking at,” Benson said. 

Benson said they respect the FDA’s decision but are also disappointed because the test is easy to use and doesn’t require a full blood draw like many others. 

Bluffdale City Councilman Jeff Gaston is another person who was caught off guard by the FDA’s decision. 

He says his mother got an accurate result from the test, the results of which came back days before another test also confirmed she had COVID-19 antibodies. 

He also believes his results were accurate. 

“I’ve seen some of the results which matched up with some of the other tests. It gives me a peace of mind knowing I haven’t had the virus, and I need to still be extremely careful,” Gaston said. 

However, other people who paid almost $70 to take the test said there was no paper trail or record they could take home to verify the results. 

The cities are looking at ways to redirect people to other COVID-19 anti-body tests. 

The cities paid for some of their employees to take the test, including first responders, and will likely be reimbursed by CARES Act money for that expense.

However, Bluffdale also fronted nearly $25,000 to get the FDA COVID-19 antibody tests up and running, though Councilman Gaston expects that money will be reimbursed as well. 

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FDA COVID-19 antibody tests are pulled from approval