FDA approves new rapid antigen test

Aug 27, 2020 - 02:34 PM
FDA product update

The Food and Drug Administration yesterday authorized the first COVID-19 antigen test that allows health care providers to read the results in minutes directly from the testing card, similar to some pregnancy tests.

Under the emergency use authorization, laboratories certified under the Clinical Laboratory Improvement Amendment to perform moderate, high or waived complexity tests and health care providers with a CLIA certificate of waiver, compliance or accreditation may use the test, made by Abbott Diagnostics Scarborough Inc. The company plans to make up to 50 million tests available monthly in the U.S. beginning in early October. 

Antigen tests are less sensitive than molecular tests, meaning negative results may need to be confirmed with a molecular test, FDA said.

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