Metro Health Warns Many Antibody Tests Haven't Been Approved By FDA

You may have heard it called a serology test.or an antibody test for the coronavirus.

Metro Health Director Dr. Dawn Emerick is voicing concerns about a number of such tests that are being sold in the community.

The antibody test is different from the viral test. The viral test uses a nasal swab to diagnose whether you have COVID-19. The antibody test isn’t checking for the virus itself, but instead it looks to see whether your immune system has responded to the infection, indicating whether you have had the virus, but didn't show symptoms. People are getting the antibody test to determine whether they may have at some point had the virus, but didn't know it.

Emerick says of the 90 that are antibody tests that are on the market, only 4 have been approved by the Food and Drug Administration.

She says it's possible more of the tests will be approved, but for now, "the science isn't there." She warned, "the public should be very cautious"

According to Emrerick, the four serology or antibody tests that have been approved are: Cellex, Mount Sinai Laboratory, Ortho Clinical Diagnostics and Chembio Diagnostic System, Inc.

Emerick also says because such tests results are not reported to health departments, anyone who might show antibodies will still not be able to donate plasma to help treat coronavirus patients, because they were never actually diagnosed with COVID-19.


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