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Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA Safety Communication

Date Issued: May 28, 2021

The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography). The FDA has serious concerns about the performance of the SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) and believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared or approved by FDA for distribution and use in the United States.

Lepu Medical Technology is recalling their SARS-CoV-2 Antigen Rapid Test Kit and their Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography). The FDA is aware that these unauthorized tests were distributed to pharmacies to be sold for at-home testing by consumers as well as offered for sale directly to consumers.

Recommendations for Health Care Providers, Test Users, and Caregivers

  • Stop using the SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography)

SARS-CoV-2 Antigen Rapid Test Kit

  • Health care providers: Consider retesting your patients using a different SARS-CoV-2 diagnostic test if you suspect an inaccurate result was given recently, such as in the last 2 weeks, by the Lepu Medical SARS-Cov-2 Antigen test. 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.
  • Test users and caregivers: Talk to your health care provider if you are concerned that you might have been tested with the Lepu Medical Technology Antigen Rapid Test and you have concerns about your test results.
  • Report any problems you experience with the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test to the FDA, including suspected false results.

Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography)

  • Health care providers: Consider retesting your patients using a different SARS-CoV-2 antibody test if you suspect a recent or prior COVID-19 infection.
  • Test users and caregivers: Talk to your health care provider if you are concerned that you might have been tested with the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) and you have concerns about your test results.
  • Report any problems you experience with the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) test to the FDA, including suspected false results.

Device Description

The SARS-CoV-2 Antigen Rapid Test Kit uses a nasal swab sample to detect proteins, called antigens, from the SARS-CoV-2 virus. The Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) looks for antibodies in a person’s immune system produced in response to SARS-CoV-2, the virus that causes COVID-19, and should not be used diagnose an active COVID-19 infection. The Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) uses serum, plasma, or blood samples.

Potential Risk of False Results

SARS-CoV-2 Antigen Rapid Test Kit

  • The FDA has serious concerns about the performance of the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and believes there is likely a high risk of false results when using this test. In addition, Lepu Medical Technology does not have authorization, clearance, or approval from the FDA to distribute this test.
  • False-negative results 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 healthcare, long-term care, and other facilities based on these false test results. Actions to limit exposure based on false negative results might not be taken, such as isolating peoples, limiting contact with family and friends, and limiting ability to work.
  • False-positive results may lead to delayed diagnosis or 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) based on false test results.

Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography)

  • The FDA has serious concerns about the performance of the Leccurate SARS-CoV-2 Antibody (Colloidal Gold Immunochromatography) Rapid Test and believes there is likely a high risk of false results when using this test. In addition, Lepu Medical Technology does not have authorization, clearance, or approval from the FDA to distribute this test.
  • A 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.
  • A false-positive antibody test results could 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, and is providing this information to help educate health care providers, test users, and caregivers, and reduce the risk of false 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 Device

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.

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.

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