FDA Approves 1st COVID-19 Antigen Test for Emergency Use

The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Md., on Nov. 4, 2009. Jason Reed/Reuters

Federal authorities announced on May 9 that emergency-use authorization has been granted for the first antigen test for COVID-19.

The Food and Drug Administration (FDA) said the authorization was issued on May 8 to Quidel Corporation for an antigen test, a new type of diagnostic test designed for rapid detection of the CCP virus.

Antigen tests detect the presence of the disease, while antibody tests indicate past infection.

FDA chief scientist Denise Hinton said in a letter (pdf) to Quidel about its test, called the Sofia 2 SARS Antigen FIA, that, based on the scientific evidence, “it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks.”

Hinton added that the emergency-use approval for the new antigen test doesn’t mean it’s been cleared or approved by the FDA for widespread use, but only for use by authorized laboratories.

The headquarters of the U.S. Food and Drug Administration (FDA) in Silver Spring, Md., on Nov. 4, 2009. Jason Reed/Reuters

“In the fight against COVID-19, our employees are truly making a difference, and I am tremendously proud of our organization’s ability to quickly develop and mobilize an accurate rapid antigen test,” said Douglas Bryant, president of Quidel Corporation, in a release.

Bryant told The Wall Street Journal that Quidel has already placed around 36,000 test-analyzer instruments in medical facilities around the country, and that production would go from 200,000 tests the week of May 11 “to more than a million a week within several weeks.”

The FDA has, in the past, issued emergency-use authorization for another type of active infection test, the polymerase chain reaction (PCR) test, which is a diagnostic technique that detects genetic material from a virus.

“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 said in the release.

A doctor looks at protein samples at Novavax labs in Rockville, Md., on March 20, 2020, one of the labs developing a vaccine for the virus that causes COVID-19. Andrew Caballero-Reynolds/AFP/Getty Images

Former FDA Commissioner Scott Gottlieb, explaining in a CNBC op-ed how antigen tests work, wrote, “One approach is based on the use of antibodies that adhere to parts of the virus that contribute to its symptoms called antigens.

“If virus is present, the antibodies bind to these viral antigens and produce a chemical reaction that signals the presence of an infection.”

Based in San Diego, Quidel specializes in tests for flu, strep, and infectious diseases.

“The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient,” the company’s CEO stated.