At-Home Antibody Tests Should Not Replace COVID-19 Tests Performed by Medical Providers

At-home tests not approved by FDA yet

April 10, 2020

With the continued global outbreak of the coronavirus (COVID-19), the community should be warned that some test kits becoming commercially available to consumers are not licensed or validated for at-home use, and are not a substitute for official swab tests performed by medical providers. These tests may not be reliable in determining whether a person is, or has been, infected with the coronavirus. At-home tests may also provide a false sense of security as they cannot always detect antibodies that haven’t had time to develop yet.

The following statement was released by the U.S. Food and Drug Administration on March 20. The FDA is working to identify and prosecute distributors of unauthorized test kits.

“We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”

With hundreds of new at-home tests hitting the market, people are highly discouraged from reselling or try to administer them themselves until the Food and Drug Administration has approved such a test.

Those experiencing symptoms of COVID-19, such as fever, cough, or shortness of breath, should call their health care provider or the New Mexico Department of Health COVID-19 hotline immediately (1-855-600-3453). Thanks to increased statewide testing capacity, the following people may now be considered for COVID-19 testing:

  • Asymptomatic people who are close contacts or household members of New Mexico residents who have already tested positive for the coronavirus;
  • Asymptomatic residents in nursing homes;
  • Asymptomatic people in congregant settings such as homeless shelters, group homes, detention centers;
  • Symptomatic people displaying the COVID-19 symptoms of cough, fever or shortness of breath.

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Emergencies challenge the delivery and management of emergency public information, warning and emergency protective action notifications. The Albuquerque Joint Information Center (JIC) functions as a coordinated Albuquerque Metro Area public information system that will gather and analyze data related to the novel coronavirus (COVID-19) outbreak in New Mexico and serve as a source of accurate and comprehensive information.