FDA Approves First COVID-19 Antigen Test for Emergency Use
Federal authorities announced Saturday that emergency-use authorization has been granted for the first antigen test for COVID-19, the disease caused by the CCP virus.
The Food and Drugministration (FDA), in a May 9 release, said the authorization was issued late Friday to Quidel Corporation for an antigen test, a new type of diagnostic test designed for rapid detection of the virus that causes COVID-19.
Antigen tests detect the presence of the disease, while antibody tests indicate past infection.
FDA chief scientist Denise Hinton said in a letter (pdf) that Quidel’s 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.”
Hintonded that the emergency-use approval for the new antigen test does not mean it has been cleared or approved by the FDA for widespread use, but only for use by authorized laboratories.
“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, and chief executive officer 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 in the week of May 11, “to more than a million a week within several weeks.”
Another type of active infection test the FDA has, in the past, issued emergency-use authorization for is the polymerase chain reaction (PCR) test, which is a diagnostic technique that detects the genetic material from the 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.
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 thathere 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,” heded.
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.