By Dennis Thompson
Companies selling coronavirus antibody tests will be required to submit data proving accuracy within the next 10 days, or their products could be yanked from public circulation, FDA officials said.
Since mid-March, dozens of manufacturers have been allowed to sell antibody tests without providing any evidence they are accurate, under the initial policy announced by the FDA.
The intent of the initial policy was to support “the availability of antibody tests, which are an important tool in our fight against the coronavirus,” FDA Commissioner Dr. Stephen Hahn explained during a media briefing.
Unfortunately, many of the tests that came onto the market simply aren’t accurate.
A recent assessment of 14 coronavirus antibody tests now available to consumers revealed that only three delivered consistently reliable results, according a report issued by a team of more than 50 scientists.
Many antibody tests are also being falsely advertised or inappropriately marketed, said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
“Many companies are marketing them for use at home,” Shuren said. “That was never permitted under our policy, unless authorized by the FDA.”
Others are falsely claiming that their tests are FDA-approved for accuracy, or that the antibody test can be used to diagnose an active case of COVID-19, the agency said.
Antibody tests only can say whether a person has been exposed to the new coronavirus. A viral test to check for the presence of coronavirus in a person’s blood or mucous is the only way to detect active infection.
The FDA also stepped in to halt the import of bad test kits from other countries, Shuren said.
“Flexibility never meant we would allow fraud,” Shuren said in an FDA release co-authored by Dr. Anand Shah, the FDA’s deputy commissioner for medical and scientific affairs. “We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” Shuren noted.
Under the new policy, the FDA will provide manufacturers and laboratories with guidelines for gathering the accuracy data needed to acquire an Emergency Use Authorization (EUA).
All companies with an antibody test currently on the market will need to get an EUA. “Our expectation is that those who can’t do that will remove their product from the market, and we will be working with them to help them do that,” Hahn said.
To date, 12 antibody tests have been issued an EUA, including two developed by high-level diagnostic laboratories, Hahn said.
There are more than 250 antibody tests currently being reviewed by the FDA for an EUA, Hahn added.
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SOURCES: May 4, 2020, media briefing with: U.S. Food and Drug Administation (FDA) Commissioner Stephen Hahn, M.D.; Jeff Shuren, M.D., J.D., director, FDA’s Center for Devices and Radiological Health