FDA WARNS AGAINST USING LuSys LABORATORIES COVID-19 Tests

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lusys laboratories covid-19 antigen test
False results reported at the LuSys Laboratories COVID-19 tests. 

LuSys laboratories covid-19 antigen test – News

The Food and Drug Administration (FDA) has advised healthcare providers to discontinue the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva), and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test as the accuracy of these tests is uncertain.

These tests were not authorized for distribution in the United States and may produce false results. They may also be distributed under the company names Luscient Diagnostics or Vivera Pharmaceuticals or with the trade name EagleDx. The tests were used in laboratories and for at-home testing.

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Healthcare providers are advised to retest patients using a different diagnostic test for SARS-CoV-2 if the antigen test was administered within the past two weeks. Any issues related to SARS-CoV-2 testing should be reported to the FDA’s MedWatch Voluntary Reporting Form.

Vivera Pharmaceuticals, a company named in the FDA communication, has clarified that it works closely with leading FDA Emergency Use Authorized testing manufacturers and that its association with LuSys Laboratories and Luscient Diagnostics was limited to the development of a U.S made antibody test for COVID-19 in mid-2020. The company has reached out to the FDA to correct the advisory.

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REFRENCE SOURCES:

https://www.fda.gov/medical-devices/safety-communications/stop-using-lusys-laboratories-covid-19-tests-fda-safety-communication

https://www.prnewswire.com/news-releases/vivera-pharmaceuticals-issues-statement-regarding-lusys-laboratories-covid-19-tests-301461073.html