FDA is backing away from allowing antibody tests after false claims about its accuracy


In March, the FDA allowed companies to start selling tests without providing evidence that they were working, in order to address the Corona Virus pandemic, but over time some tests turned out to be inaccurate or fraudulent while other companies claimed that it could be used at home, which is What the FDA does not allow.

According to the Daily Mail website, he explained that the US Food and Drug Administration (FDA) said it was taking action because some sellers had made false claims about the tests and their accuracy, and companies would now have to show their testing work or risk being pulled from the market.


Last March, the FDA was under pressure to increase test options, so the agency allowed companies to start selling tests as long as they notified the agency of their plans and submitted a disclaimer, including that they were not approved by the FDA.

The purpose of the policy was to allow the “flexibility” needed to increase production quickly, according to the officials.

The decision came, after weeks of criticism from doctors, laboratory specialists and members of Congress who said the FDA’s lack of oversight led to disorganized tests.

Text from FDA test clearance
Text from FDA test clearance

“However, flexibility has never meant that we will allow fraud,” Dr. Anand Shah, Deputy Commissioner of the Food and Drug Administration, said in a statement. “Unfortunately we see unscrupulous actors marketing fraudulent test kits and using the epidemic as an opportunity to benefit Americans.”

The agency admitted that there were problems with spoofing and fake marketing among the 160 tests launched in the United States, where some companies claimed that their tests could be used at home, although the FDA did not allow such use.

In a statement, the FDA said that, given the antibody tests, access and accuracy have been given priority on COVID-19 antibody tests. And the FDA will continue to take steps to strike the appropriate balance of assurances that the antibody test is accurate And reliable, with timely access to such tests as constantly evolving conditions and public health needs. ”

To date, the US Food and Drug Administration (FDA) has awarded 11 Antibody test , Which means that its methods, materials and accuracy have passed a crowd by agency regulators.

US Food and Drug Administration statement
US Food and Drug Administration statement

Companies that currently have test kits on the market without permission from the FDA will now be required to submit formal requests to regulators within 10 working days, as manufacturers who are released 10 days later will be able to deliver their orders after their tests are validated.

Additionally, the U.S. Food and Drug Administration (FDA) previously advised against using antibody tests to diagnose coronavirus because it takes time for the antibodies to develop.


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