The US Food and Drug Administration said Wednesday it had authorized a new antigen test to diagnose coronavirus infection -- the third test of its kind to receive emergency use authorization from the agency.
The British-made LumiraDx test can analyze a sample within 12 minutes, the FDA said.
What are antigen tests: Unlike time-consuming PCR tests, antigen tests look for specific parts of a virus rather than multiplying any viral genetic material present.
How it works: The test requires a nasal swab and can give results right away, instead of having to be sent off for analysis. Health officials hope such tests can help the US ramp up coronavirus testing.
“LumiraDx Platform is a novel, flexible, highly scalable and low cost rapid point-of-care test that will significantly contribute to our scaling up and expanding testing platforms for SARS-CoV-2. This technology has built-in digital connectivity, almost everything we hope for in new testing platforms coming to market,” Adm. Dr. Brett Giroir, the testing “czar” on the White House coronavirus task force, said in a statement.
Reliability: The FDA published data from company submission showing the test has 97.6% sensitivity, meaning it catches 97.6% of cases correctly, and 96.6% specificity, meaning it correctly rules out infection 96.6% of the time.