Certain COVID-19 Serology/Antibody Tests Should Not Be Used

https://www.fda.gov/medical-devices/letters-health-care-providers/certain-covid-19-serologyantibody-tests-should-not-be-used-letter-clinical-laboratory-staff-and?utm_campaign=Certain%20COVID-19%20Serology%2FAb%20Test%20Should%20Not%20Be%20Used&utm_medium=email&utm_source=Eloqua

A MedWatch Safety Alert was added to the FDA Medical Device Safety webpage.  TOPIC: Certain COVID-19 Serology/Antibody Tests Should Not Be Used: FDA Letter to Clinical Laboratory Staff and Health Care Providers AUDIENCE: Consumer, Patient, Health Professional, Risk Manager, Laboratory ISSUE: The FDA is issuing this communication to ensure that laboratories and health care providers who may still have within their stock tests on FDA's “removed” test list, or have used such tests, are aware that these tests may have demonstrated poor clinical performance or lack adequate information to support clinical performance. Results for antibody tests that have been evaluated through the Department of Health and Human Services (HHS) National Institutes of Health (NIH), National Cancer Institute (NCI) independent evaluation program may be found on FDA’s Independent Evaluations of COVID-19 Serological Tests webpage. The FDA will continue to keep health care providers and the public informed if new or additional information becomes available. BACKGROUND: On May 21, 2020, the FDA provided a list of antibody tests from commercial manufacturers that had been removed from the antibody test notification list. This “removed” test list includes tests where significant clinical performance problems were identified that cannot be or were not addressed by the commercial manufacturer in a timely manner, tests for which an Emergency Use Authorization (EUA) request was not submitted by a commercial manufacturer of a serology test within a reasonable period of time as outlined in FDA’s guidance, and tests voluntarily withdrawn from the notification list by the respective commercial manufacturer.  FDA will continue to update this “removed” test list. False positive serology test results can lead to an incorrect assessment that the tested person had an immune response to SARS-CoV-2. Although it is unknown whether the presence of antibodies confers immunity, an individual with a false positive result may not take necessary precautions against virus exposure. This may increase the individual’s risk of infection and may lead the person to not seek testing if later infected, which could potentially increase the spread of the disease. False negative test results can lead to an incorrect assessment that the tested person has not had an adaptive immune response to SARS-CoV-2 and has not had recent or prior infection with SARS-CoV-2. An individual with a false negative result may restrict activities deemed acceptable for individuals with evidence of an antibody response to SARS-CoV-2. A false negative serology test result may also lead to additional unnecessary diagnostic evaluations. In the context of the current public health emergency, incorrect serological test results could negatively impact the effectiveness of infection control activities.

RECOMMENDATION: The FDA recommends laboratories and health care providers: Stop using the antibody tests listed on FDA’s “removed” test list. Evaluate, given the patient’s clinical presentation and medical history, whether prior test results generated using these tests may have been incorrect, and whether the patient should be retested using an FDA-authorized test. Remove from your stock any remaining tests that are listed on FDA’s “removed” test list. Report any issues with using COVID-19 tests to the FDA. The sale of fraudulent COVID-19 products is a threat to the public health. Consumers and health care professionals can help by reporting suspected fraud to the FDA’s Health Fraud Program or the Office of Criminal Investigations. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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