Health care providers should stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test as the performance of these tests has not been adequately established, according to the Food and Drug Administration (FDA).
In a safety communication, the Agency noted that the tests, which were not authorized for distribution in the United States, may lead to false results. It is believed that the tests were distributed for use in laboratories and for at-home testing. The tests may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx.
Health care providers should consider retesting patients using a different SARS-CoV-2 diagnostic test if the antigen test was given less than 2 weeks prior.
Issues related to SARS-CoV-2 testing should be reported to the FDA’s MedWatch Voluntary Reporting Form.
In response to the FDA communication, Vivera Pharmaceuticals’ CEO Paul Edalat, said, “It is incredibly misleading to list Vivera as a brand of LuSys or Luscient Diagnostics. Vivera works closely with leading manufacturers of FDA Emergency Use Authorized testing, such as Access Bio.”
According to Vivera, the work done with LuSys was limited to development of a US made antibody test for COVID-19 in mid-2020. The Company has reached out to the Agency to correct the advisory.
- Stop using LuSys Laboratories COVID-19 Tests: FDA Safety Communication. News release. US Food and Drug Administration. March 30, 2004. Accessed April 30, 2020. https://www.fda.gov/medical-devices/safety-communications/stop-using-lusys-laboratories-covid-19-tests-fda-safety-communication.
- Vivera Pharmaceuticals Issues Statement Regarding LuSys Laboratories COVID-19 Tests. News release. January 14, 2022. https://www.prnewswire.com/news-releases/vivera-pharmaceuticals-issues-statement-regarding-lusys-laboratories-covid-19-tests-301461073.html.