FDA issues warning against use of antigen and antibody tests from a company

FDA has warned that people using antigen and antibody tests rom LuSys Laboratories should consult their healthcare provider


A warning has been issued by the United States Food and Drug Administration over the usage of a company’s antibody and antigen tests. The agency has said that the tests might be giving out false results making its results unreliable. The warning was issued on January 11, 2022 and the company LuSys Laboratories COVID-19 Antigen Test and its COVID-19 IgG/IgM Antibody Test have not been approved or authorized for distribution or use in the United States.

The antigen test kit makes use of a nasal swab or saliva and the antibody test makes use of plasma, serum or blood samples. Reports say that the test kits have been distributed for use in laboratories or for at-home testing. The kits are currently being sold under the name Luscient Diagnostics or Vivera Pharmaceuticals or with the trade name EagleDx. The FDA has warned that both the tests could give out false positive or false negative results but it has not indicated as to which one is more prevalent.

The agency has warned that people who have used the antigen or antibody tests and have concerns regarding the results, then it is recommended to consult a healthcare provider. People who are experiencing problems with the results can report on the MedWatch Voluntary Reporting Form of the FDA. The agency has however recommended not to use the above mentioned tests. It was in the month of November, 2021 when nearly two million COVID-19 tests were recalled by the manufacturer Ellume due to a potential for false positive results.

The FDA has mentioned about the COVID-19 testing kits that have been approved for use in the United States. The number of testing for COVID has increased in recent times due to the omicron variant scare. The omicron variant is said to be highly contagious and people who are infected with it are experiencing mild to moderate symptoms.

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