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FDA revokes emergency use of Chembio Diagnostic System used to test for COVID-19 antobodies

Posted at 10:24 AM, Jun 17, 2020
and last updated 2020-06-17 22:10:24-04

SANDY, Utah — The U.S. Food and Drug Administration on Wednesday revoked the emergency use authorization of the Chembio Diagnostic System that has been used in COVID-19 antibody tests.

The FDA took the action based on concerns over the accuracy of the test.

It said after a review and evaluation of the company, the tests administered by Chembio are showing to generate higher than expected rates of false results.

The FDA said it is not reasonable to believe that the test is effective in detecting antibodies against COVID-19 so it revoked their authorization.

For more information on the revocation of the tests, click here.

In Utah, RapidScreen Solutions is suspending all of its antibody testing, including in Layton and Lehi this week. Chembio provided the company with the finger prick tests.

RapidScreen Solutions has tested thousands of Utahns and defended the tests in the past.

Now, the company is suspending all testing until it can better understand the issue with the tests.

“Once we fully understand what the reasoning is then that can guide our decisions in regards to the previous tests we’ve done," Dr. Paul Benson said.

Benson says the next steps are to evaluate and look for a new test to use.

If you’ve scheduled testing for Lehi or Layton this week you will be refunded.

For more information on Covid-19 Antibody testing from Utah leaders , click here and from the CDC, click here.

The testing was performed in several cities across the state, some sent FOX 13 News statements following the news:

“Riverton City is proud to have offered the opportunity for residents to be screened for COVID-19 antibodies. We offered 500 tests to the public that sold out within 24 hours. The goal of the program was to offer residents who may have not displayed symptoms of COVID-19 an opportunity for peace of mind. Given that that the antibody tests used in the screening program were authorized by the FDA for emergency use only, it is not surprising the approval of the tests was temporary. We hope to see the FDA continue to work to provide options for antibody screenings in the future.

Questions about the tests accuracy or procedure can be directed to Rapid Screen Solutions, LLC.” – Riverton City

“In various South Valley cities, RapidScreen Solutions had administered the Chembio antibody test, which was the only FDA-approved finger-prick option at the time. We were informed today that the FDA revoked the emergency use authorization (EUA) of Chembio’s antibody test. We recommend anyone who has questions or concerns to speak with RapidScreen Solutions. Draper City is working on providing a follow-up option for residents who were previously tested to cross-check their results with a blood draw test.” - Draper Mayor Troy Walker.

“As a member of the broader community, Vineyard was happy to facilitate a location for residents to receive pilot testing for COVID-19. During a time of uncertainty, the FDA gave emergency approval to help pilot and discover the best options for antibody testing. At that time, we needed to move forward as cities, counties, and a state to understand the spread of COVID-19. While the testing has shown consistent results, we are grateful for the FDA’s continuous efforts to provide the best antibody tests available to our residents. We are grateful to be moving to a place of stabilization.” - Mayor Julie Fullmer of Vineyard.