COVID Antibody Test Results Questioned After FDA Suspends Test

SALT LAKE CITY, Utah  – Several thousand Utahns got a COVID-19 antibody test three or four weeks ago through Rapid Screen Solutions, but those results are now in question after the U.S. Food & Drug Administration suspended the test used by the Utah-based company. 

The medical director of Rapid Screen supported the vigilance of the FDA but remained confident in their results.

“We, of course, respect their decision, and appreciate what they’re doing to protect the public,” said Dr. Paul Benson, owner and clinical director of Rapid Screen Solutions, based in Layton.

There’s a high demand for antibody testing right now because so many of us want to find out if we had the coronavirus and didn’t know it. So, Benson said, his company wants to find another test it can use.

“The demand has been high,” he said. “We felt like this was a great service that we provided, and we want to be able to continue to provide that service. But, we also want to use the best tests for that.”

Three weeks ago, the cities of Draper, Bluffdale, Riverton and Vineyard sponsored antibody testing through RapidScreen Solutions. The antibody testing quickly sold out at $70 per test. Blood was taken from a finger prick.

Rapid Screen was using a test made by Chembio out of New York. Since the Utah company doesn’t produce the tests, they have to do their own internal verifications.

“I feel very confident with the results we’ve been providing,” said Benson. “We have been doing internal verifications on the test. We’ve been retesting whenever there was question.”

They screened more than 3,400 people from 63 cities for COVID-19 antibodies in seven days. They found 11.8% tested positive for one or both antibodies.

But Thursday night, the FDA revoked the emergency use authorization for the Chembio test because data “showed that this test generates a higher than expected rate of false results.” 

Rapid Screen released the following statement:

“Rapid Screen Solutions applauds the FDA diligence and assurance of a high standard of care. We will continue to follow the FDA’s guidance and will no longer administer the Chembio tests. We will continue monitoring this quickly developing situation and reviewing rapid screen antibody test options that may be available or may become available. Protecting Utahns and providing the best available results is our top priority.

“Our processes and redundancy have demonstrated replicable results using the best available rapid response antibody screening methodology. We have found very consistent results with this test both through retesting any questionable results and through our internal verification processes. We appreciate the important policy making and monitoring role of the FDA and will continue using the best available screening tests and methodology going forward.”

The FDA believes it is not effective in detecting antibodies.

As a result, Rapid Screen has canceled testing that people had signed up for and paid for in Layton and Lehi later this week. They are in the process of refunding money to those who had signed up.

“It’s time for us to regroup and look back at the other tests that have their emergency use authorization in place and determine what test would be best to use moving forward,” said Benson.

While the FDA decision certainly calls the test results into question, Benson stands by the tests that they administered.

“For most individuals, I feel very confident that what we’ve given them is correct.”

Benson points out that we are learning new things about the coronavirus and the testing surrounding it all the time. 

As they learn new things, he said, they need to make adjustments the best they can to serve the public. They hope to resume rapid COVID-19 antibody testing as soon as they find another test in which the FDA and the company are confident.