| Antibody screening could be key to helping understand the spread of Covid-19 in the U.S. Since the first tests hit the market, they have also been plagued by controversy.
Now, the Food and Drug Administration says that the kits will get stricter oversight.
Antibody tests typically can assess whether or not someone has come into contact with the new coronavirus—not just whether they have active virus in their system. But such exams are also more difficult to develop than diagnostics, and as Stephanie Baker reports, more prone to issues such as false-positives. Adding to that, some manufacturers have allegedly made false or inappropriate claims about their products, incorrectly marketing them to consumers as tests that can assess whether they might have Covid-19 immunity.
Recently, a group of California scientists studied the reliability of the tests. Of 14 analyzed, only three produced consistently reliable results. A controversial Stanford University antibody study tweaked its methodology after critics asserted, among other things, that the researchers had put too much stock in the accuracy of the test.
Acknowledging such issues, last week the White House suggested the use of two antibody tests at the same time to allow for the results to be cross-checked. On Monday, the FDA finally seemed to say enough is enough. Since mid-March the agency has allowed antibody tests to be sold without any government sign-off. Now, manufacturers will have to apply for authorization within 10 days of their products coming to market and meet requirements to gain clearance.
“Flexibility never meant we would allow fraud,” the health agency said in a statement announcing the policy change. “We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”—Kristen V. Brown |