FDA has issued a letter to healthcare providers to recommend the continued use of serological (antibody) tests to help identify people who may have been exposed to the SARS-CoV-2 virus or may 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. In the future, serological tests may potentially be used to help determine, together with other clinical data, whether some individuals may be less susceptible to infection.
The agency’s letter includes recommendations for healthcare providers, a summary of actions FDA has taken to address serological testing, and instructions for reporting problems with a test.
Read the full text of the letter from FDA.