COVID Test False Positive: FDA Warns Against Using This At Home Kit

Amid the rising number of COVID-19 cases fueled by the Omicron variant, securing an appointment to get tested has become impossible, which has resulted in people turning to at-home kits.

However, on Tuesday, the Food and Drug Administration (FDA) issued a release warning people to avoid using a particular at-home testing kit due to inaccurate results.

The FDA advised those looking to check whether they may be infected with COVID-19 to avoid using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test.

The FDA believes there’s a high risk that using either of the tests will lead to false results. The tests may also be sold under company names Vivera Pharmaceuticals, Luscient Diagnostics, or EagleDx.

Furthermore, the agency revealed the tests have not been approved, cleared, or authorized for use or distribution by the FDA in the United States.

The FDA warns that a false positive COVID-19 test can lead to a delay in a correct diagnosis and treatment for the person’s actual illness as well as the spread of the virus if the individual chooses to isolate with others who have tested positive.

Meanwhile, a false negative COVID test could result in a person taking few precautions to stop the spread of the virus and a delayed diagnosis and treatment.

Healthcare workers who used the antigen test on patients less than two weeks ago have been advised to retest patients using a different brand if they suspect the results were inaccurate.

While consumers are discouraged from using the antigen and antibody tests from LuSys Laboratories, the FDA has shared a list of approved at-home COVID-19 testing kits, including iHealth, BinaxNow, and CareStart.