FDA Removes Certain Serology/Antibody Tests From the Market

Arent Fox

Arent Fox

The FDA has just published a list of certain already-on-the-market serology/antibody tests from commercial manufacturers that should not be distributed unless and until an Emergency Use Authorization (EUA) is issued for the test.

Serology/Antibody Tests refer to tests that detect antibodies to COVID-19. Because antibodies are part of the body's immune response to exposure and not to the virus itself, testing for such antibodies cannot be used to diagnose a COVID-19 infection but it can measure whether someone has had the virus in the past. These tests are important for evaluating the next steps in the fight against the pandemic, such as by providing information on disease prevalence and the frequency of asymptomatic infection, and also by identifying potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe or immediately life-threatening disease.

As readers of these Alerts will know, in the early stages of the pandemic, the FDA allowed commercial manufacturers to market serology/antibody tests by only requiring them to “validate” their tests, and then to notify the FDA that the tests had been validated and that they would be labeled to comply with certain labeling restrictions. Widespread problems with the tests – and, in some cases, outright fraud – ensued. On May 4, the FDA decided that enough was enough and it then required that both existing and new commercial manufacturers submit full EUAs within 10 days. The Agency also established new and strict performance “recommendations” for specificity and sensitivity for all serology test developers.

On May 21, the FDA decided to take action by publishing a list of those commercial manufacturers of serology/antibody tests who either had not submitted EUAs for their tests, or had submitted EUAs where significant problems were found, or who voluntarily withdrew their test notifications. The Agency said that it “expects that the tests on this list will not be distributed unless and until an EUA is issued for the test and FDA may take additional actions as appropriate.”

The list, which includes some 29 entries, can be found here. More tests will no doubt be added to the list as FDA said that over 200 commercial serology/antibody tests had been allowed on the market before May 4.

As of May 22, the FDA had authorized 109 tests under EUAs, which include 96 molecular (PCR) tests, 12 serology/antibody tests, and 1 antigen test.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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