FDA issues emergency authorization for first coronavirus antigen test

The Food and Drug Administration has given diagnostic health care manufacturer Quidel Corp. emergency-use authorization for its COVID-19 antigen test, the first of its kind.

“The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic,” the agency said in a statement Saturday.

“These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs,” it added.

Health experts and lawmakers have said widespread testing is key to safely reopening the country but warn that current testing falls short.

The administration has touted its efforts to quickly expand testing in the country, while experts have recommended the U.S. do at least 4 million tests per week, The Wall Street Journal noted.

Antigen testing could play an important part in increasing testing capacity, the FDA said.

Currently, there are two types of tests in wide use for COVID-19: polymerase chain reaction (PCR) tests and antibody tests.

PCR tests are used to diagnose active cases of the disease and are highly accurate but can take longer to show results. Antibody tests, meanwhile, work to see if someone’s body has created antibodies to combat the virus, though health experts warn that antibodies don’t necessarily mean that someone is immune to COVID-19.

Antigen tests don’t work in the same way PCR tests do but can similarly detect if a person is currently sick with COVID-19.

“One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes,” the FDA said. “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.”

In addition to being faster than PCR tests, antigen tests are also cheaper and easier to mass-produce because of their simplistic design, the agency said.

“Antigen tests are also important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests and once multiple manufacturers enter the market, can potentially scale to test millions of Americans per day due to their simpler design, helping our country better identify infection rates closer to real time,” the FDA explained.

The Journal reported that Quidel has put roughly 36,000 test-analyzer instruments in hospital labs, emergency rooms and doctors’ offices across the country.

“We are ramping up manufacturing to go from 200,000 tests next week [week of May 11] to more than a million a week within several weeks,” Douglas Bryant, Quidel’s CEO, told the newspaper.