domingo, 19 de abril de 2020

Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers

https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providers?utm_campaign=2020-04-17%20Use%20of%20Serological%20%28Antibody%29%20Tests%20for%20COVID-19&utm_medium=email&utm_source=Eloqua

Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers


Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to recommend that health care providers continue to use serological (antibody) tests to help identify people who may have been exposed to SARS-CoV-2 virus or may have recovered from the COVID-19 infection.

Health care 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 Letter to Health Care Providers includes important information about serological tests, including:

  • Recommendations for health care providers.
  • Actions that the FDA has taken to address serological tests.
  • Instructions for reporting problems with a test.

Questions?

If you have questions about serology tests, contact the Division of Industry and Consumer Education (DICE).

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