Oklahoma City, Okla — The Food and Drug Administration is now requiring authorization for COVID-19 antibody testing.
When the coronavirus first got to the United States, the F.D.A. admits they weren’t requiring any type of approval for antibody tests because they were so needed.
The tests work by looking for certain proteins in a blood sample that would indicate you have or have had a coronavirus infection.
Accurate tests can catch the virus before you show symptoms, or well after you’ve recovered.
The F.D.A. now said there was a lot of false marketing and even fraud around antibody testing.
There are now only a handful of authorized tests but they have a better chance of accuracy, the F.D.A. said.
According to Dr. James Wantuck, the Chief Medical Officer and Co-Founder of PlushCare, “The test we are using at Plushcare is a test by Abbot Labs and it has gone through that process with the F.D.A., so it’s F.D.A. authorized, and its 99.4% accurate.” He went on to say, “some of the tests out there were pretty wildly inaccurate.”
Just a reminder, antibody tests are not meant for those who are symptomatic. If you think you have COVID-19 symptoms, call your health provider.