August 28, 2020
Abbott Laboratories announced on Wednesday, August 26, that its new rapid COVID-19 antigen test—which will cost $5 and provide results in 15 minutes—has been granted emergency use authorization by the U.S. Food and Drug Administration.
The Illinois-based company said it plans to ship tens of millions of the test kit, called the BinaxNOW COVID-19 Ag Card, next month, and expects to increase to 50 million tests a month in early October. Results can be read directly from the testing card—which is about the size of a credit card. This simple design is fast and efficient for healthcare providers and patients and does not require the use of an analyzer.
“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,” Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a public statement from the agency.
How it works: 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; two lines indicate a positive result.
Where it can be used: This test could be used at point-of-care settings, like a doctor’s office, emergency room, or some schools. It has been authorized for use in patients suspected of COVID-19 by their healthcare provider within seven days of symptom onset.
Test details: In general, antigen tests are very specific, but are not as sensitive as molecular tests. Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions. Negative results from an antigen test should be considered in the context of clinical observations, patient history, and epidemiological information.
Research contact: @FDA