The U.S. Food and Drug Administration (FDA) is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test due to the high risk of false results.
The regulatory agency said the particular tests’ -- sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx --performance has not been “adequately established.”
According to the FDA, neither test has “been authorized, cleared, or approved by the FDA for distribution or use in the United States.”
“False-negative antigen test results mean that the test says the person does not have COVID-19, but the person is actually infected. 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,” said the FDA.
And false-positive antigen test results mean that the test says the person has COVID-19, but they are actually not infected.
“A false-positive result may lead to a delay in both the correct diagnosis and the initiation of an appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease that is not COVID-19. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together),” said the FDA.
For a full list of FDA approved tests, click here.