As antibody tests are becoming more frequent in discussions about the current coronavirus pandemic, there is plenty of talk about fake antibody tests. The Food and Drug Administration (FDA) is now requiring FDA-approval on COVID-19 antibody tests in the US after weeks of fake or defective tests entering the market.
The FDA’s March guidelines allowed a higher level of flexibility for unverified antibody tests to enter the markets to help detect the presence/exposure of COVID-19. However, antibody tests were not meant to diagnose active coronavirus infections, which was how some fake test developers marketed their products.
The FDA is reversing its previous stance because they no longer think the risk of fake tests is worth lighter regulations for the sake of more available tests.
“Flexibility never meant we would allow fraud,” FDA officials Anand Shah and Jeff Shuren wrote in an official statement. “We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”
According to the statement, there were varying false statements from antibody test developers. Some claimed false FDA approval or that they could accurately diagnose COVID-19. Fake antibody tests also included those marketed as at-home tests, which also weren’t approved under the FDA’s March guidelines.
“When we become aware of these issues, we have and will continue to take appropriate action against firms unlawfully marketing their tests, for example, by detaining and refusing illegitimate test kits at the border,” the two FDA officials explained.
Coronavirus antibody test developers must now submit data to the FDA in order to prove their tests work and meet FDA guidelines for sensitivity and specificity before they can be used in the US.
High-quality, approved tests can help researchers understand an individual’s and population’s exposure to COVID-19. A person who has been exposed to COVID-19 will most likely have antibodies to the virus in their blood.