At-home testing for COVID-19 has been a key tool during the pandemic. Because of their widespread use, the Food and Drug Administration (FDA) has issued a warning against two home COVID tests that can give a false result. Here’s what you need to know.
On Tuesday, January 11, 2022, the US Food and Drug Administration (FDA) issued a warning against the use of LuSys Laboratories antigen tests and LuSys Laboratories antibody tests. These two tests may also be sold under the names EagleDx, Vivera Pharmaceuticals, or Luscient Diagnostics.
“The performance of these tests has not been adequately demonstrated, and the Food and Drug Administration believes that there is likely to be a high risk of false results when these tests are used,” the agency explained. Neither test has been authorized, approved, or approved by the US Food and Drug Administration for distribution or use in the United States.
The Food and Drug Administration believes that these two tests are distributed for both home and laboratory use. The LuSys Laboratories COVID-19 antigen test uses either a nasal swap sample or a saliva sample to detect antigens, which are proteins from the SARS-CoV-2 virus that causes COVID-19. The LuSys Laboratories COVID-19 IgG/IgM Antibody Test uses blood, plasma, or serum samples to look for Sars-CoV-2-related antibodies.
According to the FDA’s warning, these tests yielded false-positive and false-negative results. “False-negative antigen test results mean that the test indicates that the person is not infected with COVID-19 but that the person is actually infected,” the agency explained. “False-positive antigen test results mean that the test indicates that the person has COVID-19 but is in fact not infected.”
If you use one of the two potentially wrong tests, the FDA recommends another COVID-19 test using a different brand, and any concerns should be directed to your health care team. Healthcare professionals are also instructed to contact and retest patients who may have had a result from one of these tests.
“The FDA regularly monitors the marketing of unauthorized, unapproved, or unauthorized tests, including reports of problems with test performance or results,” the agency said. “The FDA will keep the general public informed if important new information becomes available.”
Anyone concerned about the possibility of a false test is encouraged to submit a report through the FDA’s MedWatch volunteer reporting form.