WASHINGTON D.C. (CelebrityAccess) — On Thursday, the Food & Drug Administration issued an emergency use authorization for the first rapid coronavirus test.
The test, which detects the virus’s antigens, proteins found on the surface of the coronavirus, rather than the virus itself, produces results that can be read directly from a card, similar in design to a pregnancy test instead of requiring processing by a lab.
For the test, a healthcare provider swabs a patient’s nose and then places the sample on a test card. The card is subjected to chemical reagents with results available in about 15 minutes directly from the testing card.
Antigen tests are less reliable than molecular tests and negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions, the FDA said.
The test has been approved for use at point-of-care settings, like a doctor’s office, emergency room or some schools. However, given the simple nature of the test, it may be made broadly available, the FDA said.
The test, designed by Abbott Laboratories, will sell for approximately $5 dollars and is the first test that does not require a machine for results.
According to Abbott, the company plans to make up to 50 million tests available monthly in the U.S. at the beginning of October 2020.
“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. Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.