The US Food and Drug Administration issued an emergency use authorization Wednesday to BinaxNOW Covid-19 Ag Card – a rapid antigen test made by Abbott that can detect Covid-19 infection in 15 minutes.
It uses the same type of technology as a flu test.
“BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others,” the company wrote in a statement.
The test accurately identifies positive cases 97% of the time, with a false negative rate of less than 3% when tested in symptomatic patients within the first seven days of symptom onset. It has a false negative rate of under 3%.
"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, a professor of virology at Baylor College of Medicine, said in a statement released by Abbott.
"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," he said.
Some context: Petrosino’s labs have been leading efforts to provide Covid-19 testing for the college and Harris County, which includes Houston.
The company said the test, which is the size of a credit card, will cost $5 and will come with free companion mobile app so that people who test negative can display a temporary health pass that is renewed and date-stamped each time a new test is taken. Abbott says they anticipate producing 50 million tests a month by October.
The BinaxNOW Covid-19 Ag Card is the fourth antigen test to receive an EUA from the FDA.
Antigen tests, which look for pieces of the virus, are not as reliable as traditional PCR tests, which look for the virus’ genetic material, but they are a quicker, less expensive and less invasive. PCR tests have been beset by supply chain problems as well as back-ups at labs which have delayed results and frustrated patients, doctors and public health experts alike.