FDA Authorizes First Diagnostic Test Where Results Can Be Read From a Card

The U.S. FDA issued an emergency use authorization on August 26, 2020, for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests. A healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. After waiting 15 minutes, the healthcare provider reads the results directly from the testing card. One line indicates a negative result; 2 lines indicate a positive result.

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card. This means people will know if they have the virus in almost real-time,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.