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FDA Issues More Warning Letters to Companies Inappropriately Marketing Antibody Tests

When it rains – it pours. It’s amazing how quickly the testing scene has changed from no tests to test kits for all sold on every corner. The most recent and the most dangerous get-rich-quick scams is selling at-home self testing.

Antibody (serology) tests are very important and urgently needed for general population. These tests detect antibodies to SARS-CoV-2, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection.  However, most rapid kits that look like a small cartridge are highly inaccurate and some are simply fake.

The FDA reminds consumers to be cautious of websites and stores selling products, including test kits, that claim to prevent, mitigate, treat, diagnose or cure COVID-19. Fraudulent COVID-19 products defraud consumers of money and can place consumers at risk for serious harm. Using these products may lead to delays in getting proper diagnosis and treatment of COVID-19 and other potentially serious diseases and conditions.

FDA Statement on June 17, 2020

If you are serious about the increasing risks of the COVID-19 infection, please stay away from buying test kits for home use and generally away from rapid kits that are now offered everywhere.

Make an appointment with LabFlorida to get the antibody testing done the right way.