FDA advises on continued use and limitations of serological tests for COVID-19
The U.S. Food and Drug Administration (FDA) recommends that healthcare providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. Healthcare providers should also be aware of the limitations of these tests and the risks to patients and the community if the test results are used as the sole basis to diagnose COVID-19.
The FDA is not aware of an antibody test that has been validated for diagnosis of SARS-CoV-2 infection. While the FDA remains open to receiving submissions for these tests for such uses, based on the underlying scientific principles of antibody tests, the FDA does not expect that an antibody test can be shown to definitively diagnose or exclude SARS-CoV-2 infection.
To help ensure that healthcare providers have access to accurate tests, the FDA is working with the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) on a validation project to help identify the most promising serological tests. This validation project is ongoing, and we hope to have additional information to share in the future.
The FDA will continue to keep healthcare providers and the public informed if new or additional information becomes available.
Serological tests detect antibodies present in the blood when the body is responding to a specific infection, like COVID-19. They detect the body’s immune response to the infection caused by the virus rather than detecting the virus itself. Experience with other viruses suggests that individuals whose blood contains antibodies associated with SARS-CoV-2 infection—provided they are recovered and not currently infected with the virus—may be able to resume work and other daily activities in society. They may also be eligible to serve as potential donors of convalescent plasma.
The FDA recommends healthcare providers:
· Continue to use serological (antibody) tests, as appropriate, and be aware of their limitations.
· Do not use serological (antibody) tests as the sole basis to diagnose COVID-19 but instead as information about whether a person may have been exposed.
· Be aware that not all marketed serological tests have been evaluated by the FDA. The FDA’s authorized tests, including serological tests, are listed on the Emergency Use Authorization (EUA) page. Tests being offered under a policy outlined in the FDA’s COVID-19 Diagnostic Policy Guidance are listed on our FAQ page. Such tests have not been reviewed by the FDA, unless an EUA has also been submitted and reviewed by 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.
