Covid Antibody Tests Not Definitive: FDA

FDA says it is not aware of an antibody test that has been validated for diagnosing SARS-CoV-2 infection. Writing in a special MedWatch safety alert, the agency says that while it remains open to receiving the submission of tests for such use, based on the underlying scientific principles of antibody tests, it does not expect that an antibody test can be shown to definitively diagnose or exclude SARS-CoV-2 infection.

That said, however, the notice says FDA recommends that healthcare providers continue to use serological tests 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,” it adds.

The notice includes recommendations for healthcare providers.