PHOENIX - It's a quick test giving quick results.
It can show if you had Coronavirus in the past, and could be immune now.
It's an antibody test that is being offered by more clinics around Arizona.
But, most of the tests have not been approved by the government.
Right now, about 70 manufacturers are on a Food and Drug Administration (FDA) list to make and distribute the test. But only one test has been evaluated and approved by the FDA.
Dr. Bobbi Pritt has concerns about how those tests are being performed.
She's a clinical microbiologist with Mayo Clinic.
On its website, the FDA says it's allowing these unapproved antibody tests under certain conditions including that manufacturers determined "their tests are accurate and reliable."
Dr. Pritt says the lack of FDA oversight isn't a concern if the people giving it have the skills and abilities to evaluate it first.
Dr. Pritt says Mayo Clinic tested hundreds of specimens to come up with two antibody tests they trust. And neither has been approved by the FDA.
She's also concerned that tests could give false negative or positive results.
Dr. Pritt gives one example involving the common cold.
She says 90% of adults have antibodies related to coronavirus already because it's linked to the cold.
"So when you say something is positive does that really mean people had COVID-19 or do they have some other virus that is cross-reacting," she asks.
The FDA says there are three things things providers should not tell you:
- That the tests can be done at home. They can't.
- That the antibody test determines current COVID-19 It doesn't.
- That their test is FDA approved when it is not.
Dr. Pritt says clinics are not a concern if they validate the test and its accuracy.
Also they need to have experts in place to read the results correctly.
But she says generally, a hospital lab setting may be best if you get the antibody test.
Click here for FDA comments involving the COVID-19 antibody test.
