FDA issues emergency approval of new antigen test that is cheaper, faster and simpler

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.

Antigen tests are “important in the overall response against covid-19” and can “potentially scale to test millions of Americans per day” once other manufacturers enter the market, the FDA statement said. The FDA said it anticipates authorizing more antigen tests in the near future.