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First Rapid COVID-19 Antigen Test Gets Green Light

In a potential game-changer in the ongoing fight to expand COVID-19 testing, the FDA has authorized a new kind of test that can be used by certain health care providers on-site to diagnose patients with the SARS-CoV-2 virus within minutes instead of days.

Sofia2 combo photo
Quidel’s Sofia 2 SARS Antigen FIA test is the first rapid point-of-care test to be authorized in the US. • Source: Quidel Corp.

The US Food and Drug Administration has given emergency use authorization (EUA) to the first rapid antigen test meant to diagnose whether a patient has the COVID-19 virus. While not as accurate as other tests that look for the virus’ genetic material, the new test could help health care workers find infections much faster.

On 8 May, the FDA announced it had authorized the Quidel Corp. Sofia 2 SARS Antigen FIA test. The test can be analyzed by high- and moderate-complexity laboratories authorized...

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