Rebound

Actions

FDA tightens scrutiny on antibody tests

Agency sees "fraud" and questions accuracy
FDA tightens scrutiny on antibody tests
Posted at 9:49 PM, May 04, 2020
and last updated 2020-05-05 00:49:31-04

As Arizona Governor Doug Ducey continues talking about increased Coronavirus testing statewide, the federal agency overseeing the test makers is tightening scrutiny.

Since March, the Food and Drug Administration has allowed Coronavirus antibody tests on the market without overseeing accuracy.

They approved 12 antibody tests.

But because of the virus emergency, the FDA allowed more than 150 other antibody tests to be marketed with just manufacturer verification of accuracy.

As more of the tests were marketed at clinics throughout the state, The Rebound Arizona has raised questions about accuracy.

Now, the FDA has changed its policy.

The new rules mean the tests must now meet the FDA's "specificity and sensitivity" criteria.

Makers have two weeks to provide data to the FDA.

If that doesn't happen, the tests can either be pulled or not allowed.

The FDA says they see "unscrupulous actors marketing fraudulent test kits".

They admit "a concerning number of commercial serology (antibody) tests... are performing poorly based on independent evaluation."

The change comes as Arizona is far behind most states in testing and is now pushing it.

That includes antibody tests that the Governor's office has said could be as many as 1000-3000 daily.

Despite that, the state's own Department of Health Services is not recommending antibody testing.

A department spokesperson told us "it is unknown if a positive serologic (antibody) test for Covid-19 means that someone is immune to Covid-19".

The spokesperson says tests may be "falsely positive".... "therefore ADHS is not recommending the use of Covid-19 serologic tests."

Last week the governor’s office told us "antibody testing is an important tool to provide."

They said it provides more data when making decisions and while it's not a cure all, it’s an important step.