If the test you have has the same name as one listed on this page, follow the instructions below to check for signs that it is counterfeit or to confirm that it is the real, FDA-authorized product. For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs.Ĭheck this page regularly to see if the FDA is aware of counterfeit versions of the tests. The FDA has a list of authorized at-home OTC COVID-19 diagnostic tests. How do I know if my at-home OTC COVID-19 diagnostic test is FDA-authorized? How do I report a problem with an at-home OTC COVID-19 diagnostic test?.What is the FDA doing about counterfeit at-home OTC COVID-19 diagnostic tests?.What should I do if I have a counterfeit at-home OTC COVID-19 diagnostic test?.What products has FDA identified as counterfeit at-home OTC COVID-19 diagnostic tests?.What are some signs that an at-home OTC COVID-19 diagnostic test may be counterfeit?.
How do I know if my at-home OTC COVID-19 diagnostic test is FDA-authorized?.
#CVS COVID TESTS RESULTS HOW TO#
The FDA will update this page to list counterfeit at-home OTC COVID-19 diagnostic tests to alert the public, including test users, caregivers, health care providers, and distributors, and to provide information on how to identify counterfeit tests. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are housed together. A false-positive result may lead to a delay in both the correct diagnosis and appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease that is not COVID-19. A false-positive antigen test result means that the test says the person has COVID-19 but they actually do not have COVID-19.When false negative test results are received, actions to limit exposure to an infected person might not be taken, such as isolating people, limiting contact with family and friends, or limiting access to places of employment. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are housed together in health care, long-term care, and other facilities based on these false test results. A false-negative result may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death. A false-negative antigen test result means that the test says the person does not have COVID-19 but they actually do have COVID-19.You may risk unknowingly spreading COVID-19 and may delay or stop appropriate medical treatment for COVID-19 if you use a counterfeit test.
The performance of these counterfeit tests has not been adequately established and the FDA is concerned about the risk of false results when people use these unauthorized tests. These counterfeit tests should not be used or distributed.Ĭounterfeit COVID-19 tests are tests that are not authorized, cleared, or approved by the FDA for distribution or use in the United States, but are made to look like authorized tests so the users will think they are the real, FDA-authorized test. The FDA is aware of counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States.
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