the U.S. Food and Drug Administration warns people to stop using two COVID-19 tests produced by LuSys Laboratories, citing a high risk of false results when using the tests.
The LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/M Antibody Test may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or under the trade name EagleDx. The company’s website states that their “COVID-19 Antigen Rapid Test has been submitted to the FDA EUA for review.”
TODAY contacted the company with a comment and did not immediately hear back.
The FDA said in a press release that the tests may have been used in both At home and lab testing. The antigen test uses a nasal swab to determine an active infection, while the antibody test is a blood sample that looks for antibodies produced in response to a COVID-19 infection. Antibody tests may indicate a previous infection with the virus.
The administration said on Jan. 11 that all test users, healthcare providers and health personnel will stop using company-produced tests. Those who have been tested by the brand’s products should consult their healthcare providers if they are concerned about the test results.
The FDA warned that the tests could produce either false positives — a positive result when a person is negative for COVID-19 or antibodies — or false negatives, which would be a negative result when a person is actually positive.
The FDA warned that false negative results on antigen testing may “lead to further spread of the SARS-CoV-2 virus” because “measures may not be taken to limit exposure to an infected person”. False positive results may delay treatment for the correct diagnosis, the administration added.
The FDA said they check regularly marketing “unauthorized, unapproved, or unapproved testing” and asking the public to report any problems with testing.
If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to: report the problem via the MedWatch Voluntary Report Form.