FDA Update on Antibody Testing Supports TAG Recommendations.

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FDA has removed some antibody tests from its EUA list, revised its policy, and made recommendations for the use of the tests. The changes support TAG’s recommendations that anyone considering antibody tests fully understand the test capabilities and specificities and what they can and will do with the results.

 

In brief:

• FDA posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

• The revised policy increases specifications for validation data and specificity and sensitivity thresholds for serology test developers.

• This is being done because FDA has seen “unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety” with false claims.

• FDA states that those who use an antibody test need to understand its limitations and use test results as just one piece of data to inform decision making. All tests can provide at least some false results and have inherent limitations

 

“That is why antibody tests should only be used as part of a well-conceived testing plan and why the results should always be interpreted by appropriate experts,” the policy states.