FDA Grants Emergency Use Authorization For 1st Coronavirus Antigen Test

Antigen tests are a common screening tool that doctors use for other infections, such as influenza or strep throat, but this is the first antigen test specific to the coronavirus.

The Food and Drug Administration has announced that it has granted its first emergency authorization to a new type of test that can detect the coronavirus, called an antigen test.

The test looks for protein fragments associated with the virus. The sample is collected with a nasal swab. It can produce a result in minutes, the FDA said in a statement. The agency notes that compared to already approved genetic testing, the antigen test is cheaper and easier to use and could “potentially scale to test millions of Americans per day” once multiple manufacturers enter the market.

The new type of coronavirus screening, an antigen test manufactured by Quidel Corp., was granted emergency authorization by the U.S. Food and Drug Administration on Friday night.

Antigen tests are a common screening tool that doctors use for other infections, such as influenza or strep throat, but this is the first antigen test specific to the coronavirus.

It is conducted by a nasal swab and immediately tested in the doctor’s office or other point-of-care location, producing diagnostic results within minutes by quickly detecting proteins found on or within the virus. In a statement announcing the emergency authorization of Quidel Corp.’s kit, the FDA said that antigen tests are cheaper to produce, simpler to conduct and easier to implement at scale than the current testing apparatus, which has relied on polymerase chain reaction (PCR) tests that detect genetic material from the virus.

“It’s a really important tool,” said Amesh Adalja, an infectious disease physician and senior scholar at Johns Hopkins University Center for Health Security. “This is now the next step in simplifying testing.”

Quidel Corp. said that its test, called the Sofia 2 SARS Antigen FIA, can produce results within 15 minutes. The test cartridges can be placed in its Sofia 2 machine or manually developed on a countertop. Quidel is already shipping the test kits to customers, the company said in a statement.

Two other types of tests for the coronavirus have received the emergency authorization. One, called a polymerase chain reaction, or PCR test, is a molecular diagnostic tool that identifies the virus’s genetic material. The other is an antibody test.

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