FDA Warns Of False Positives With COVID Antigen Tests

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WASHINGTON, D.C. -- The FDA issued an alert to health care providers about the possibility of false positives from antigen tests for COVID-19. 

The FDA said it is aware of false positives in nursing homes and other settings. Some of the false test results may be the result of the user not following test instructions.

Rapid result tests detect proteins (antigens) on the surface of the virus and can return results without lab equipment in just 15 minutes.  Experts liken the difference between this test and  the more accurate PCR test as the difference between a pair of binoculars  and a high-powered telescope. The FDA issued an emergency use authorization for these tests back in May.

The FDA cautioned medical professionals to follow the instructions that come with the test and be careful not to open the package prior to use. It's also important to check the results at the time specified on the package. Reading results before or after that time can yield an inaccurate result.

The agency suggests following up a positive test with a more accurate PCR test to confirm and to consider the patients symptoms if a test comes back negative.

The FDA also said that it's important to thoroughly clean any area where the tests will be used.

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