School, college and other closings for Monday

MPR News helps you turn down the noise and build shared understanding. Turn up your support for this public resource and keep trusted journalism accessible to all. 

Turn Up Your Support

The U.S. Food and Drug Administration announced Saturday 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 and 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.

So far, only San Diego-based Quidel Corporation has received authorization for the tests. That authorization was granted late Friday.

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.

Antigen testing is not without its shortcomings. The FDA notes that this test is less reliable at ruling out infection in patients and that negative results "may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative."

"Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests," the agency said. "This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection."

The FDA says that it expects more antigen tests to be authorized and that they "will play a critical role in the fight against COVID-19." 

Health

COVID-19

Jason Slotkin

Author

The agency announced approval for the diagnostic method on Saturday. Cheaper and easier to administer than genetic tests for the virus, it could potentially expand daily testing to millions — though it’s not without its shortcomings.

FDA grants emergency use authorization for first coronavirus antigen test

Go Deeper.

Like this?

News you can use in your inbox