FDA tightens rules for companies producing antibody tests

COVID-19. Image: CDC

May 4 (UPI) — The U.S. Food and Drug Administration on Monday tightened rules for companies that produce a blood test for antibodies to the COVID-19 virus, after concerns about their accuracy and reliability.

Under the new rules, companies must now submit, within 10 days, the required emergency-use paperwork and data proving that their tests work.

The tests are designed to show whether patients who have recovered from COVID-19 have antibodies in their blood that make them more immune to the coronavirus. They can also show whether a person had the coronavirus but was asymptomatic. The FDA said 12 tests have so far been authorized and more than 200 are in pre-approval phases.

Failure to submit the data and paperwork will result in a delisting.

“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” Anand Shah, FDA deputy commissioner for medical and scientific affairs, said in a statement.

Shah said some tests have performed poorly, given bad results or have been used incorrectly, and some manufacturers have sold tests that falsely claimed they were FDA-approved.

More than 1.1 million cases have been reported in the United States since the start of the pandemic, according to Johns Hopkins University, and more than 67,600 patients have died.

“FDA will continue to take steps to appropriately balance assurances that an antibody test is accurate & reliable with timely access to such tests as the continually evolving circumstances & public health needs warrant,” FDA Director Stephen Hahn tweeted Monday.

Those who have recovered are also being asked by the FDA to donate blood plasma for an experimental treatment that aims to transfer immunity to other patients.

Testing for the presence of COVID-19 antibodies is potentially part of any future strategy to identify those who can safely return to their jobs or work in high-risk settings with a greater infection rate.

The World Health Organization cautioned in April that there was no proof yet that a patient who’s recovered is immune from catching the disease again.


Please enter your comment!
Please enter your name here