Coronavirus Testing: FDA Revises Policy On Antibody Tests To Weed Out Fraud

The Food and Drug Administration on Monday reconsidered its decision to allow 100 commercial coronavirus antibody testing kits on the market without determining their efficacy, announcing requirements that companies apply for emergency use approval. The companies will have 10 days to show their tests work.

The tests are designed to determine whether an individual has developed immunity to the coronavirus pathogen. They are not for use in determining active disease.

It also is unknown how long the presumed immunity will last.

Former FDA Commissioner Scott Gottlieb told CNBC Monday antibody tests should be repeated three times to determine whether an individual has coronavirus antibodies.

"I wouldn't put stock in any single result," he said.

Doctors are hoping antibodies from people who recovered from the virus can be used to treat sick Americans through the manufacture of convalescent plasma, which is made by removing blood plasma from a recovered individual.

“Whether a test should be a ticket for someone to go back to work as the sole item, my opinion on that would be no, because there are a lot of unanswered questions,” FDA Commissioner Stephen Hahn told reporters. Experts say no test is 100% accurate, and false positives could put more people at risk.

FDA officials defended the March 16 decision to allow the tests on the market, calling it appropriate for trying to get a leg-up on the unfolding pandemic. They acknowledged, however, “unscrupulous actors” produced “fraudulent test kits” to take advantage of Americans’ anxiety over the COVID-19 pandemic.

“Flexibility never meant we would allow fraud,” Drs. Anand Shaw, deputy commissioner for medical and scientific affairs, and Jeff Shuren, director of the Center For Devices And Radiological Health, wrote on the FDA’s website.

The revised rules call for commercial manufacturers to submit review requests along with their validation data. The agency also issued thresholds for assessing efficacy.

“The FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the NIH [National Institutes of Health],” Shaw and Shuren said.

The officials said 12 tests so far won emergency use authorization in recent days. Some 200 more are under review.