A COVID-19 test that takes 15 minutes and can be run without lab equipment was just granted emergency use authorization by the Food and Drug Administration. It will cost $5, and runs on a simple card that uses the same technology as a pregnancy test.
The test, called BinaxNOW, is produced by the health care company Abbott. The company is also launching an app that syncs up with the tests, and gives people who test negative for the virus a “digital health pass” that they can display on their phone. CEO Robert Ford said in a statement that the combination of the test and the app offer a “comprehensive testing solution.”
The company said in a press release that it plans to produce 50 million tests per month by October.
“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,” said Jeff Shuren, director of the FDA Center for Devices and Radiological Health, in a statement.
Abbott gets EUA for their lateral flow Covid test. This significant entry could help democratize testing, making more tests more available to people in more austere settings that don’t have all the trappings found in a medical office; including schools. https://t.co/QGOrBmY1pV
— Scott Gottlieb, MD (@ScottGottliebMD) August 26, 2020
The test can be used in doctors’ offices, emergency rooms, and even schools, according to the FDA statement. It runs off a nasal swab. Then, the patient nasal sample gets inserted directly into the BinaxNOW card, and a colored line appears if the test is positive for coronavirus.
BinaxNOW works by detecting the small proteins on the surface of the coronavirus, rather than the genetic sequences of the virus itself. Tests that look for proteins, called antigen tests, instead of the virus tend to be less accurate. Some researchers, though, argue that frequent, cheap testing with a less-accurate test is the best way to control the COVID-19 pandemic.
Abbott says that the test correctly diagnoses a coronavirus infection 97.1 percent of the time, and correctly returns a negative result 98.5 percent of the time.
Most COVID-19 tests available today have to be sent off to a lab for analysis. This summer, people around the United States have reported waiting up to a week for 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,” said Joseph Petrosino, a professor of molecular virology and microbiology at Baylor College of Medicine, in a statement from Abbott.