The Food and Drug Administration States That the Use of At-Home COVID-19 Tests Poses Serious Risk of Harm and Cautions Against At-Home Test Use

The Food and Drug Administration, or “FDA,” is cautioning consumers against the use of COVID-19 tests designated for use at home. The FDA states that it has not authorized any form of COVID-19 diagnostic tests for at-home use, nor has it endorsed any prevention or treatment claims made by U.S. companies. Further, the FDA has actively prohibited many companies from marketing their at-home test kits in an effort to safeguard the public, including Austin, Texas’ Everlywell, and San Francisco, California’s Nurx.

The FDA is concerned that many of the at-home tests produced by companies are fraudulent. Fraudulent or faulty tests pose the risk of returning false negatives to users. False negatives will lead people who are infected to believe they are uninfected, causing them to spread the virus under the mistaken belief that they are healthy.

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