Amid the growing number of COVID-19 cases fueled by the Omicron variant, it has become impossible to secure appointments for testing, which has led people to return to home-based kits.
However, the Food and Drug Administration (FDA) on Tuesday Issued a statement Warning people to avoid using special home-based test kits due to incorrect results.
The FDA has advised Avoid using the LuSys Laboratories COVID-19 Antigen Test (Nasal / Saliva) and the LuSys Laboratories COVID-19 IgG / IgM antibody test to find out if you may be infected with COVID-19.
The FDA believes that there is a high risk that any test will lead to inaccurate results. Tests can also be sold under the company names Vivera Pharmaceuticals, Luscient Diagnostics, or EagleDx.
In addition, the agency disclosed that the tests have not been approved, vacated, or authorized by the FDA for use or distribution in the United States.
The FDA warns that false positives COVID-19 test There may be delays in the correct diagnosis and treatment of a person’s actual disease as well as delays in the spread of the virus if the person chooses to be isolated from others who have tested positive.
Meanwhile, a false negative Covid test The person may need to take precautions to prevent the spread of the virus and delay diagnosis and treatment.
Health workers who used antigen tests on patients less than two weeks ago were advised to re-test patients using a different brand if they suspected that the results were incorrect.
While discouraging consumers from using antigen and antibody tests from LuSys labs, the FDA Shared a list Approved in-house COVID-19 test kits, including iHealth, BinaxNow, and CareStart.