New FDA Guidelines issued for Covid Antibody tests

New FDA Guidelines issued for Covid Antibody tests

Hey, Pluto,
This article only mentions the antibody tests. Have they issued similar guidelines for virus detection?

If so, do we also meet their new criteria? Seems like yes to me if it is similar to the glucose meter performance.

Quote:

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Under the updated guidelines, companies that are selling the tests are now required to send the FDA an application for “emergency-use authorization” (EUA), along with data showing the tests’ accuracy within 10 business days, the agency said in a statement. Tests will need to be found 90 percent “sensitive,” or able to detect CCP virus antibodies, and 95 percent “specific,” or able to avoid false-positive results.

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New FDA Guidelines for Covid Antibody Tests

Thanks in advance for whatever light you can shine on the dark corners of my brain.