The U.S. Food and Drug Administration (FDA) issued a safety communication to warn people and healthcare providers to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test.
The FDA said it has not authorized the tests for distribution in the United States, and the agency said it “believes there is likely a high risk of false results when using these tests.” The tests may have been distributed for at-home or lab testing.
The FDA also said the products may also be sold under the company names of Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx.
If the antigen test was given less than two weeks ago, healthcare personnel consider retesting their patients using a different SARS-CoV-2 diagnostic test if they suspect an inaccurate result, the FDA said. 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.
Healthcare personnel also should consider retesting their patients using a different SARS-CoV-2 antibody test if they suspect a recent or prior COVID-19 infection.
The LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) uses a nasal swab, or a saliva (spit) sample intended to detect proteins, called antigens, from the SARS-CoV-2 virus.
The LuSys Laboratories COVID-19 IgG/IgM Antibody Test uses serum, plasma, or blood samples. The antibody test is intended to look for antibodies produced in response to SARS-CoV-2, the virus that causes COVID-19, by a person’s immune system, indicating a recent or previous infection.
