Manufacturers of antibody tests for the COVID-19 virus must now prove the tests’ accuracy to the FDA before they can begin marketing them. And those who do not submit their validation information to the FDA within 10 days may have those tests pulled from the market.
The policy reversal follows criticism of the agency’s March 16 decision to allow such test manufacturers to self-validate without reporting the results to the FDA. More than 100 such self-validated tests are on the market, raising concerns about their accuracy, including from the American Medical Association.
Serological tests are needed to show who has developed antibodies and possible immunity to the virus, although no one has shown how long such immunity may last or how protective it may be. Pressure to increase serological testing has been mounting as more people have recovered from the virus and demands to reopen the country intensify.
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 people could use them to self-test at home. The National Institutes of Health (NIH) and a group of independent scientists have separately found that a number of serological tests for COVID-19 are performing poorly or inconsistently.
The revised policy requires commercial antibody test developers to submit emergency use authorization (EUA) requests, with their validation data, within 10 business days from the date they notified the FDA that they were performing validation testing.
Under the updated policy, high-complexity laboratories developing their own tests still must have a Clinical Laboratory Improvement Amendments (CLIA) certificate provided by the Centers for Medicare and Medicaid Services to legally develop a serology test. Under CLIA, only those laboratories are permitted to perform tests that have not been FDA-authorized. They are still encouraged to seek authorization through an EUA.
Some CLIA-certified laboratories have conducted their own validation of commercial manufacturers’ tests without FDA involvement and used the ones they considered fit for their intended purpose, the agency acknowledged.
The new policy also provides performance threshold recommendations for specificity and sensitivity for all serology test developers.
The FDA had to put flexible regulations in place for serology test developers early in the pandemic given the nature of the public health emergency, according to two agency officials. In an article published online today, Anand Shah, deputy commissioner for medical and scientific affairs, and Jeff Shuren, director of the Center for Devices and Radiological Health, said these tests were not meant to be used as the sole basis for a diagnosis.
“However, flexibility never meant we would allow fraud,” they said. “We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”
The agency also plans to release the results of National Cancer Institute (NCI) reports on NCI’s efforts to validate 13 antibody tests, according to Shah and Shuren. The FDA can use the NCI data to determine whether to authorize a test, ask a test developer for more information so the test can remain on the market, or stop a company from selling its test in the U.S.
The FDA has authorized 12 antibody tests under individual EUAs, most within just the past few days, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, the agency noted. Almost half of the tests offered by commercial manufacturers are under an EUA review or a pre-EUA, a pre-submission that allows the developer to share data with or seek advice from the FDA.