FDA authorizes first diagnostic test with read-result test card

Aug. 27, 2020

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Abbott Diagnostics Scarborough for its BinaxNOW COVID-19 Ag Card, according to a press release on the FDA’s web page. The test is the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests. This simple design is fast and efficient for healthcare providers and patients and does not need 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,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

The easy-to-use test begins with a healthcare provider swabbing the patient’s nose and twirling 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.

This test offers applications in point-of-care settings and has been authorized for use in patients suspected of COVID-19 by their healthcare provider within seven days of symptom onset. Given the simple nature of this test, it is likely that these tests could be made broadly available. Abbott plans to make up to 50 million tests available monthly in the U.S. beginning in October 2020.

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