FDA Authorizes Faster COVID-19 Antigen Test from Abbott
The COVID-19 antigen test does not need the use of an analyzer and is authorized for use at point-of-care settings, such as doctor’s offices, emergency rooms, and some schools.
FDA recently issued an emergency use authorization to Abbott for the first COVID-19 antigen test where results can be read directly from the testing card.
The BinaxNOW Ag Card is fast and efficient for healthcare providers and patients, taking just 15 minutes to provide results, the federal department explained.
The test does not need the use of an analyzer and is authorized for use at point-of-care settings, including doctor’s offices, emergency rooms, and some schools.
“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,” Jeff Shuren, MD, director of FDA’s Center for Devices and Radiological Health, said in the announcement.
“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.”
The BinaxNOW Ag Card is intended for the qualitative detection of the nucleocapsid protein SARS-CoV-2 antigen. The test determines the presence of the antigen using nasal swabs from individuals suspected of having COVID-19, an Abbott press release explained.
A healthcare provider will provide the test within the first seven days of the onset of COVID-19 symptoms.
Abbott stated that it plans to make up to 50 million tests available monthly in the US at the beginning of October 2020.
So far, the company has invested hundreds of millions of dollars since April in two new US facilities to manufacture BinaxNOW at a larger scale.
The availability of near real-time COVID-19 test results could make significant progress with combatting the highly contagious virus, says Charles Chiu, MD, PhD, professor of laboratory medicine at the University of California in San Francisco.
"Our nation's frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic," said Chiu.
"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."
In previous data submitted to FDA, BinaxNOW COVID-19 Ag Card showed sensitivity of 97.1 (positive percent agreement) and specificity of 98.5 percent (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptoms, Abbott said.
"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, molecular virology and microbiology, Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County.
"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."
Additionally, Abbott stated that it will launch a mobile app, NAVICA, for iPhone and Android devices so that individuals can display their results when entering facilities that require proof of testing.
If test results are negative, the app will display a digital health pass, But if test results are positive, people will receive a message to quarantine and talk to their doctor, Abbott said.
Healthcare providers in all settings will be required to report positive results to the CDC and other public health authorities, even if they do not use the app.
"We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives. This allows people to share that information with those who need to know,” said Robert B. Ford, president and chief executive officer atAbbott.
“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."
