The FDA Says To Stop Using These Two COVID-19 Tests
The FDA is warning people to stop using this specific brand of COVID-19 tests.
The tests that are in question are the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The FDA is advising the public that these tests may also be sold under the following names: Luscient Diagnostics or Vivera Pharmaceuticals or with the trade name EagleDx.
The reason the FDA is advising the public to stop using these tests is that they haven’t been authorized and potentially present a "high risk of false results."
"Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States," the FDA said in a statement Tuesday.
By receiving a false negative on an antigen test a person would be led to believe that they do not have COVID-19 when they are actually sick.
By receiving a false negative on an antibody test a person would be led to believe that they do not have antibodies to COVID-10 when they do actually have them.
If you have used one of these tests either at home or in a health care setting then you are encouraged to reach out to your health care provider about the situation and get retested.