The U.S. Food and Drug Administration is warning people to stop using some COVID-19 tests because there is a likely high risk of false results.
The FDA issued the warning on Tuesday, advising against the use of LuSys Laboratories Antigen Tests and LuSys Laboratories Antibody Tests.
The tests may also be sold under the names Luscient Diagnostics, Vivera Pharmaceuticals or EagleDx.
"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," the agency said. "Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States."
The FDA said the tests were distributed for use in laboratories and for at-home use.
The LuSys Laboratories Antigen Test uses a nasal swab or a saliva sample intended to detect proteins, called antigens, from the SARS-CoV-2 virus, indicating a current infection.
The LuSys Laboratories Antibody Test uses serum, plasma or blood samples to look for antibodies produced in response to the SARS-CoV-2 virus, indicating a recent or previous infection.
The FDA said both tests returned false-negative and false-positive results.
A false-negative antigen test result says the person does not have COVID-19 when they are actually infected. On the other hand, a false-positive antigen test result says the person has COVID-19 but they are actually not infected.
It works the same for the antibody test. A false-negative antibody test result says the person does not have antibodies to the SARS-CoV-2 virus when the person actually does have antibodies. And a false-positive antibody test result says the person does have antibodies to the SARS-CoV-2 virus, when they actually do not.
If you used one of the potentially faulty tests, the FDA recommends getting retested using a different brand. Talk to your health care provider if you have concerns about your test results. Health care professionals who may have administered the faulty tests are also urged to contact and retest patients.
"The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results," the agency said. "The FDA will keep the public informed if significant new information becomes available."
If you think you had a problem with a SARS-CoV-2 test or have a faulty device, the FDA encourages you to file a report through the MedWatch Voluntary Reporting Form.