The Food and Drug Administration is warning people and laboratories to stop using a specific brand of COVID-19 antigen and antibody tests. It said the tests haven't been authorized and present a "high risk of false results."
The tests are the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The FDA said they may be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals or with the trade name EagleDx.
"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.
It's believed the tests were distributed both for at-home and laboratory testing.
A false negative on an antigen test may tell a person they do not have COVID-19 when they actually do have it, the FDA said. A false positive would mean the person would be told they have COVID-19 but really don't.
A false negative on an antibody test would mean the person is told they don't have antibodies to the coronavirus but actually do have them. A false positive means the opposite -- the test says they do have the antibodies but really don't.
People and caregivers who have used the tests are urged by the FDA to talk to health care providers if they think they were tested with the LuSys tests and are concerned about the results. Health care providers who used the tests recently are asked to consider retesting their patients with a different brand.
