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Stop using these at-home COVID-19 antigen tests, FDA warns

TODAY logo TODAY 1/14/2022 Kerry Breen

The U.S. Food and Drug Administration is warning people to stop using two COVID-19 tests produced by LuSys Laboratories, citing a high risk of false results when using the tests.

The LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/M Antibody Test may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx. On the company's website, they say their "COVID-19 Antigen Rapid Test has been submitted to the FDA EUA for review."

TODAY reached out to the company for a comment and did not immediately hear back.

The FDA said in a press release that the tests may have been used in both at-home and laboratory testing. The antigen test uses a nasal swab to determine an active infection, while the antibody test is a blood sample that looks for antibodies produced in response to COVID-19 infection. Antibody tests may indicate past infection with the virus.

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The administration said on Jan. 11 that all test users, caregivers and health care personnel stop using tests produced by the company. Those who were tested by the brand’s products should consult with their health care providers if they have concerns about test results.

The FDA warned that the tests could produce both false positives — a positive result when a person is negative for COVID-19 or antibodies — or false negatives, which would be a negative result when a person is actually positive.

The FDA warned that false negative results on antigen tests can "lead to further spread of the SARS-CoV-2 virus" since "actions to limit exposure to an infected person might not be taken." False positive results can lead to a delay in treatment for the correct diagnosis, the administration added.

The FDA said that they regularly monitor the marketing of "unauthorized, unapproved, or uncleared tests" and ask the public to report any problems they may have with tests.

If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

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