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Only 8 COVID-19 antibody tests on the market OK’d by FDA

DETROIT – Advertisements for COVID-19 antibody tests have been targeting people who are wondering if they may have had the virus and not realized it.

Update: April 29, 2020 -- Michigan coronavirus (COVID-19) cases up to 40,399; Death toll now at 3,670

As a result, Congress is demanding more oversight of tests after widespread concern about their accuracy.

The FDA has unfortunately created a lot of confusion and uncertainty about these tests by allowing them to be sold without any sort of authorization.

As of Wednesday, the FDA has only verified and authorized eight tests, but there are 150 antibody tests on the market in the U.S. that have not been reviewed by the FDA and another 24 laboratories are conducting their own antibody testing with out any FDA authorization.

A team of researchers in California analyzed a dozen of the tests and found one in three produced false positives more than 10% of the time.

According to experts, the serum antibody tests -- those that involve a blood draw -- seem to be more accurate than the rapid tests that require just a finger prick.

The bottom line is that most of these tests are not reliable right now, and even if you do test positive for antibodies, it’s unclear if they will provide any immunity to the virus or how long that immunity might last.

Anyone who believes they might have coronavirus should follow the CDC guidelines. Michigan.gov has a list of resources available to those concerned about COVID-19.

More information on coronavirus (COVID-19):


About the Authors
Frank McGeorge, MD headshot

Dr. McGeorge can be seen on Local 4 News helping Metro Detroiters with health concerns when he isn't helping save lives in the emergency room at Henry Ford Hospital.

Dane Kelly headshot

Dane is a producer and media enthusiast. He previously worked freelance video production and writing jobs in Michigan, Georgia and Massachusetts. Dane graduated from the Specs Howard School of Media Arts.

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