Original Post
Date Issued: January 11, 2022
The U.S. Food and Drug Administration (FDA) is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States.
The LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx. The FDA believes that these tests were distributed for use in laboratories or for at-home testing.
Recommendations for Test Users, Caregivers, and Health Care Personnel
Stop using LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests.
COVID-19 Antigen Test (Nasal/Saliva)
- Test users and caregivers: Talk to your health care provider if you were tested with the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and you have concerns about your test results.
- Health care personnel: If the antigen test was given less than two weeks ago, consider retesting your patients using a different SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
- Report any problems you experience with the LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) to the FDA, including suspected false results. See Reporting Problems with Your Test.
COVID-19 IgG/IgM Antibody Test
- Test users and caregivers: Talk to your health care provider if you were tested with the LuSys COVID-19 IgG/IgM Antibody Test and you have concerns about your test results.
- Health care personnel: Consider retesting your patients using a different SARS-CoV-2 antibody test if you suspect a recent or prior COVID-19 infection.
- Report any problems you experience with the LuSys COVID-19 IgG/IgM Antibody Test to the FDA, including suspected false results. See Reporting Problems with Your Test.
Test Descriptions
The LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) uses a nasal swab or a saliva (spit) sample intended to detect proteins, called antigens, from the SARS-CoV-2 virus.
The LuSys Laboratories COVID-19 IgG/IgM Antibody Test uses serum, plasma, or blood samples. The antibody test is intended to look for antibodies produced in response to SARS-CoV-2, the virus that causes COVID-19, by a person’s immune system, indicating a recent or previous infection. Antibody tests should not be used to diagnose or exclude an active COVID-19 infection.
The LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under the company names Luscient Diagnostics, Vivera Pharmaceuticals, or with the trade name EagleDx. The FDA believes that these tests were distributed for use in laboratories or for at-home testing.
Potential Risk of False Test Results
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.
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.
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 [email protected] or call 800-638-2041 or 301-796-7100.
