A January 11 alert from the FDA warned consumers to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test.

According to the FDA, the performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States, the agency said on its website.

The FDA alert reports that the LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx. The FDA believes that these tests were distributed for use in laboratories or for at-home testing.

The FDA issued the following recommendations for each test:

  • COVID-19 Antigen Test (Nasal/Saliva)
    • Test users and caregivers: Talk to your health care provider if you were tested with the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and you have concerns about your test results.
    • Health care personnel: If the antigen test was given less than two weeks ago, consider retesting your patients using a different SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
    • Report any problems you experience with the LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) to the FDA, including suspected false results. See Reporting Problems with Your Test.
  • COVID-19 IgG/IgM Antibody Test
    • Test users and caregivers: Talk to your health care provider if you were tested with the LuSys COVID-19 IgG/IgM Antibody Test and you have concerns about your test results.
    • Health care personnel: Consider retesting your patients using a different SARS-CoV-2 antibody test if you suspect a recent or prior COVID-19 infection.
    • Report any problems you experience with the LuSys COVID-19 IgG/IgM Antibody Test to the FDA, including suspected false results. See Reporting Problems with Your Test.

More information is available on the FDA website.