15-Minute COVID-19 Test Given FDA Emergency Use Authorization, 150 Million Tests to be Purchased in Deal With US

The FDA has issued an emergency use authorization (EUA) for Abbott’s BinaxNOW coronavirus disease 2019 (COVID-19) Ag Card rapid test, which will be sold for $5 and provides results in 15 minutes. It is intended for the detection of nucleocapsid protein antigen from COVID-19 in nasal swabs.

CNBC reported that President Donald Trump will announce a deal with Abbott Laboratories on Thursday to purchase 150 million of the new tests for $750 million.

"This is a major development that will help our country to remain open, get Americans back to work, and kids back to school," White House communications director Alyssa Farah told CNBC.

According to a press release, the test uses lateral flow technology to ensure reliability, and is in a portable form to allow for frequent mass testing through health care providers. The test is about the size of a credit card and requires no equipment. It will be launched alongside a complementary mobile app named NAVICA.

The free app will allow patients who test negative to display a temporary digital health pass that is renewed each time they get tested and will also display the date of the test result. Organizations will be able to view and verify the information to facilitate safe entry into facilities, according to the press release.

In a clinical study, the test demonstrated 97.1% sensitivity and a specificity of 98.5% in patients suspected of COVID-19 within the first 7 days of symptom onset.

“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” said Joseph Petrosino, PhD, professor and chairman of molecular virology and microbiology at the Baylor College of Medicine, in a 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.”

Under the EUA, the test is for use by health care professionals and can be used in point-of-care settings that are operating under a Clinical Laboratory Improvement Amendments waiver, certificate of compliance, or certificate of accreditation. The test can be performed by physicians, nurses, medical assistants and technicians, pharmacists, and others with minimal training needed and a patient prescription.

“Our nation’s frontline health care workers and clinical laboratory personnel have been under siege since the onset of this pandemic,” said Charles Chiu, MD, PhD, professor of laboratory medicine at the University of California, San Francisco, in a press release. “The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times, and greatly expand access to people who need it.”

The company plans to ship tens of millions of tests in September and will increase to 50 million tests per month at the beginning of October, according to the press release.

REFERENCE

• Abbott’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. 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. Accessed August 27, 2020.
• Feuer W. Trump to announce $750 million deal with Abbott for at least 150 million rapid coronavirus tests. CNBC; August 27, 2020. https://www.cnbc.com/amp/2020/08/27/trump-to-announce-750-million-deal-with-abbott-for-at-least-150-million-rapid-coronavirus-tests.html. Accessed August 27, 2020.