U.S. Food and Drug Administration chief urges caution on antibody tests
Coronavirus antibody tests have not always been accurate in other countries, and the United States should be careful not to approve their use too quickly, an official in the U.S. Food and Drug Administration said on Sunday.
Dr. Stephen Hahn, the commissioner of the FDA, said antibody tests are not designed to detect whether someone is infected now.
These tests tell doctors whether the person has been exposed to the virus at some point, and may have acquired some degree of immunity, Hahn explained.
To date, the FDA has given the green light to only one such test.
“There are a number on the market that we haven’t validated,” Hahn told the ABC programme “This Week.”
“We do expect that relatively soon.” He added.
Referring to reports from other countries of inaccurate antibody tests, Hahn said: “I think it’s really important for the American people to know that we need tests that are accurate, reliable and reproducible.”
“What we don’t want are wildly inaccurate tests.” Hahn said in an appearance on the NBC programme.