False Claims From Some Antibody Test Developers, Sellers Force FDA To Change Policy

By Staff

On Monday, the U.S. Food and Drug Administration (FDA) updated its original policy released on March 16 for COVID-19 Antibody Tests. High-quality antibody tests (a type of serological test) can help to understand a person’s and population’s exposure to COVID-19.

A person exposed to, and recovered from COVID-19 will likely have antibodies to the SARS-CoV-2 virus in their blood.

Testing for the antibody may be essential for guiding the next steps in the fight against this pandemic.

Antibody tests could provide information about the prevalence and frequency of asymptomatic infection and identify potential donors of “convalescent plasma.”

However, flexibility never meant we would allow fraud.

The flexibility in the March 16 policy allowed for early use of antibody tests to begin to answer critical population-level questions about the prevalence of COVID-19 infections in different communities, and whether the presence of antibodies conveys immunity, and, if so, for how long.

Early availability of serology tests has helped to generate valuable information for the FDA that can inform future use.

“The FDA is aware that several of these labs have conducted their own validation of commercial manufacturers’ tests they were interested in and then used those tests that were fit for purpose. Notably, the use of antibody tests in other settings, including at home, prior to issuance of an emergency use authorization (EUA), such use is not permitted under the Clinical Laboratory Improvement Amendments (CLIA), and our March 16 policy did not change that,” said Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs.

“Moreover, as we have said before, it is not accurate for developers to claim their test was authorized by the FDA if an EUA was not granted for the tests, nor should they be distributing their test if it has not been properly validated.”

To date, 12 antibody tests have been authorized under an individual EUA, most within just the past few days, and over 200 antibody tests are currently the subject of a pre-EUA or EUA review.

Under this revised policy, the FDA has outlined the following expectations for antibody test developers:

• Commercial manufacturers will submit EUA requests, with their validation data, within 10 business days from the date they notified the FDA of their validation testing OR from the date of this policy, whichever is later.

• Furthermore, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.

In mid-March, it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of this public health emergency and an understanding that the tests were not to be used as the sole basis for COVID-19 diagnosis, a fact that remains true today.

“However, flexibility never meant we would allow fraud. We, unfortunately, see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety. Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance,” said Jeff Shuren, M.D., Director, Center for Devices and Radiological Health.

“Since that time, the FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the NIH,” Shuren added.

The FDA will continue to take steps to COVID-19 testing, including antibody testing, to carefully balance the risks and benefits, including the accuracy and reliability with timely access to such tests as the continually evolving circumstances.