Following a relaxation of regulations, the US Food and Drug Administration is now dealing with a number of SARS-CoV-2 antibody tests that are not accurate, Politico reports. It adds that many have a high false positive rate.
It adds that FDA usually reviews such tests, but that it waived that step to try to quickly bring the tests to market and enable discussions of when people might be able to safely return to work. Politico notes that the FDA only reviews validation data for tests if an Emergency Use Authorization has been submitted and that seven tests have been issued an EUA.
On Friday, a subcommittee of the House of Representatives Committee on Oversight and Reform issued a memo noting that the FDA "failed to police the coronavirus serological antibody test market" and this lack of review by FDA "allowed manufacturers to make fraudulent claims about their efficacy."
"A Wild West of unregulated tests are now proliferating, and our biggest concerns are that they are unreliable, inaccurate, and in many cases making fraudulent claims about their testing results," subcommittee chair Raja Krishnamoorthi (D-Illinois) tells NPR.
According to Politico, FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health launched a program to let test manufacturers have their tests' accuracy independently assessed and that FDA is trying to make it easier for companies to apply for EUAs.
NPR notes that even if antibody tests are accurate, scientists are still unsure what the presence of SARS-CoV-2 antibodies may mean.