January 11, 2022 -- The U.S. Food and Drug Administration (FDA) has warned against using a COVID-19 antigen test from LuSys Laboratories, as well as the company's COVID-19 immunoglobulin G (IgG)/IgM antibody test. The agency believes the tests have a high risk of false results.
In addition, the FDA said that the performance of these tests has not been adequately established; neither test has been authorized, cleared, or approved by the FDA for distribution or use in the U.S., according to an email issued by the agency.
The LuSys Laboratories COVID-19 Antigen Test uses a nasal swab or a saliva sample and the COVID-19 IgG/IgM Antibody Test uses serum, plasma, or blood samples. The tests may be sold under the company names Luscient Diagnostics, Vivera Pharmaceuticals, or with the trade name EagleDx, the FDA said.
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