FDA Issues Emergency Use Authorization to New 15-Minute COVID-19 Antigen Test

Officials with the FDA have issued Emergency Use Authorization (EUA) for Abbott’s BinaxNOW COVID-19 Ag Card rapid test for the detection of coronavirus disease 2019 (COVID-19), according to a press release.

BinaxNOW delivers results in 15 minutes and will be sold for $5, Abbott said. The test, which is approximately the size of the credit card, is highly portable and easy to use, with no equipment required.

In addition, Abbott announced it will also launch NAVICA, a complementary mobile app for iPhone and Android devices, which will allow individuals who test negatively to display a temporary digital health pass that is renewed each time a person is tested through their health care provider together with the date of the test result.

Related: COVID-19 Testing Is Not an Automatic Choice for Pharmacists

“While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know,” Robert B. Ford, president and chief executive officer of Abbot, said in a press release. “We’re taking our know-how from our digitally connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible.”

For testing with BinaxNOW, a simple nasal swab is used to collect specimens from individuals suspected of having an active infection. No equipment is required to process samples or read test results. Minimal chemical reagents are required, which lessens exposure to biohazardous materials and improves safety for those administering tests.

Abbott reported that results from a clinical study evaluating BinaxNOW COVID-19 Ag Card showed sensitivity of 97.1% and specificity of 98.5% in patients suspected of COVID-19 by their health care provider within the first 7 days of symptom onset.

Under the EUA, the test will be available for use by health care professionals and can be used in point-of-care setting that are qualified to have the test performed and are operating under a Clinical Laboratory Improvement Amendments Certificate of Wavier, Certificate of Compliance, or Certificate of Accreditation.

“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” Joseph Petrosino, PhD, professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, said in the press release. “With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus.”

The Advanced Medical Technology Association estimates that test manufacturers are shipping approximately 1 million tests per day. According to Abbott, tens of millions of tests in will be shipped in September, ramping up to 50 million tests a month at the beginning of October.

Reference

Abbot’s Fast, $5, 15-Minute, Easy-to-Use COVID-19 Antigen Test Receives FDA Emergency Use Authorization; Mobile App Displays Test Results to Help Our Return to Daily Life; Ramping Production to 50 Million Tests a Month. News Release. Abbott; August 26, 2020. Accessed August 27, 2020. https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month