In my county, the government (county health department) is the one doing the testing. Our state senator pushed for it and we are the first county in the state to do it.All of the antibody testing is going to have to be approved as EUA by the FDA. None of that testing is available yet. All of this “early testing” is unapproved by the FDA’s EUA. None of it will be accepted in studies of counting by the government, and will certainly not be accepted by employers or State.
Advaite, which makes the test being used in Chester and Delaware counties, is waiting for emergency use authorization for it from the Food and Drug Administration. That requires further testing to answer such questions as: What happens if a sample contains more than just the new coronavirus? How high is the rate of false positives?
In the meantime, the FDA is letting companies use their tests without agency approval as long as they meet certain guidelines. To date, the FDA has authorized only one antibody test, made by a company in North Carolina. Many groups are working on antibody tests, including the Centers for Disease Control and Prevention.
How in the world are we supposed to know what labs are legit then? I trust your county is using a reputable lab and test manufacturer. But what about “fly by night” labs. They are being set up in my area, and claim to be operating under the FDA guidelines. The FDA is doing something very careless by allowing testing without EUA.However, some firms are falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19. The FDA will take appropriate action against firms making false claims or marketing tests that are not accurate and reliable.
This ^ is essentially my point. Unfortunately, many people don’t have judgement as good as yourself.. I personally would not get such a test unless it was being pushed or promoted by the state at this juncture, or if the FDA had approved it
“If you see them on the internet, do not buy them until we can give you a test that’s reliable for all Americans,” said Dr. Deborah Birx, coordinator of the White House coronavirus task force, at a recent briefing.