February 24 Update - FAQs on Testing for SARS-CoV-2

U.S. Food and Drug Administration sent this bulletin at 02/24/2022 02:13 PM EST

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FDA - Center for Devices and Radiological Health

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February 24 Update: Added Information on Antibody Tests for SARS-CoV-2

Thank you for your interest in the development and use of antibody tests for SARS-CoV-2.

The FDA recently:

ADDED the following question and answer:

COVID-19: Test Development and Review

  • I am developing a SARS-CoV-2 antibody test. What are the recommendations for traceability to an international standard material?

UPDATED the following questions and answers:

COVID-19 Test Uses

  • Should SARS-CoV-2 antibody test results be used to assess whether or not a person is protected from COVID-19?

FAQs on Testing

Questions?

Email CDRH-EUA-Templates@fda.hhs.gov