FDA gives special authorization to speedy COVID-19 test

The U.S. has received a boost in its efforts to conduct more COVID-19 tests after the Food and Drug Administration (FDA) granted emergency use authorization for a kit made by Abbott Laboratories.

The test, called BinaxNOW, takes just 15 minutes to produce a result, and is priced at only $5. It involves a nasal swab procedure conducted by health professionals, and a small reactive card that displays the result.

Abbott said it plans to ship tens of millions of test kits in September, ramping up to 50 million units a month at the beginning of October.

Abbott Laboratories

BinaxNOW is an antigen test, allowing faster results than the more heavily used PCR tests that require lab equipment and can take days or even weeks before a patient receives a result.

The speed advantage that comes with antigen tests can mean less reliable results, but in a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW test correctly diagnosed those with the disease 97.1% of the time, while correctly ruling out those without it 98.5% of the time.

The Illinois-based company will launch its test with a mobile app called Navica that can function as a “temporary digital health pass” for those who test negative.

“This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result,” Abbott said in a release. “Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning, and mask-wearing.”

Robert B. Ford, president and CEO of Abbott, said, “BinaxNOW and the Navica app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives.”

Abbott’s news comes just days after the FDA issued emergency use authorization for the use of convalescent blood plasma in the treatment of COVID-19 patients.

The U.S. is currently the worst-hit country in terms of the number of deaths linked to COVID-19, with the count standing at just over 183,000 as of August 26, 2020.

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