NEW YORK – The US Food and Drug Administration on Tuesday released a warning on its website cautioning against using LuSys Laboratories' COVID-19 antigen and antibody tests due to performance concerns.
The performance of both the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test "has not been adequately established" and there is "likely a high risk of false results when using these tests," according to the agency.
Neither test has been authorized or cleared by the FDA for distribution or use in the US. The tests have also been sold under the names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx, the agency said. It added that it believes the tests were distributed for use in laboratories or for at-home testing.
The FDA recommended that users who had been tested with either assay talk to their healthcare providers, and recommended healthcare providers who had offered the antigen test less than two weeks ago or the antibody test at all consider retesting patients with a different SARS-CoV-2 test.