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Testing the tests

Every COVID-19 test currently (and legally) available in the United States has been approved by the FDA under the agency’s Emergency Use Authorization (EUA)Trusted Source protocol.

The EUA permits the FDA to “allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life threatening diseases or conditions caused by chemical, biological, radiological and nuclear threat agents when there are no adequate, approved, and available alternatives.”

That has allowed novel coronavirus tests to quickly hit the market without the research and testing normally required for FDA approval.

To date, the FDA has approved 130 different RT-PCR, antigen, and antibody tests for the new coronavirus.

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