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

FDA Actions

The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The FDA is providing this information to help educate test users, caregivers, health care personnel, and the public and to reduce the risk of false test results that could lead to serious illness and death.

The FDA will keep the public informed if significant new information becomes available.

LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva):

- False-negative antigen test results mean that the test says the person does not have COVID-19 but the person is actually infected. A false-negative result may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are grouped into cohorts (that is, they are housed together) in health care, long-term care, and other facilities based on these false test results. When false negative test results are received, actions to limit exposure to an infected person might not be taken, such as isolating people, limiting contact with family and friends, or limiting access to places of employment.
- False-positive antigen test results mean that the test says the person has COVID-19 but they are actually not infected. A false-positive result may lead to a delay in both the correct diagnosis and the initiation of an appropriate treatment for the actual cause of a person's illness, which could be another life-threatening disease that is not COVID-19. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together).

LuSys Laboratories COVID-19 IgG/IgM Antibody Test:

- False-negative antibody test results mean that the test says the person does not have antibodies to the SARS-CoV-2 virus when the person actually does have antibodies. False-negative results could lead test users to take fewer precautions to prevent spread of infection if the test is used inappropriately to diagnose active infection or if the test result is interpreted to mean that they did not have a recent infection.
- False-positive antibody test results mean that the test says the person does have antibodies to the SARS-CoV-2 virus, when the person actually does not have antibodies to the SARS-CoV-2 virus. False-positive results could lead test users to take fewer precautions to protect themselves from a future SARS-CoV-2 infection if the test result is interpreted to mean that they have had a previous SARS-CoV-2 infection.

Reporting Problems with Your Test

If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions about this Safety Communication, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.