SAN ANTONIO – Viewer Question: What dangers come from taking an antibody test that’s not approved by the FDA?
“Well, there’s no danger to the person. The danger is inaccurate results and they just haven’t been validated,” Dr. Robert Frolichstein, an emergency room physician at Methodist Hospital said Thursday. “So if a test would come out positive, we don’t know with many of these tests, if that truly means a patient has those antibodies. It just takes a while to validate these types of tests, and I think the FDA is working through that and validating as many as they can.”
Dr. Dawn Emerick, director of the San Antonio Metropolitan Health District, said there is a viral test that uses a nasal swab to diagnose if a person has COVID-19. There are also tests that use a blood prick to determine whether a patient has had COVID-19 in the past. Emerick said there are 90 of those types of tests on the market, but only four have been approved by the U.S. Food and Drug Administration. The tests cannot be reported to Metro Health to be included in the daily COVID-19 count. They also can’t be used to join the convalescent plasma donation program.
The four FDA-approved antibody tests are from Cellex, Chem Bio Diagnostic System, Ortho Clinical Diagnostics and Mount Sinai Laboratory.
Click here to watch Thursday’s full Q&A segments with Dr. Frolichstein.
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