The US Food and Drug Administration (FDA) has approved BinaxNOW, a 15-minute COVID-19 test from Abbott. This is a $5 test card that works similarly to a pregnancy test. The test can be done at home without visiting a specialized laboratory, whereas most of the COVID-19 tests available today must be sent to a laboratory for analysis.
FDA issued an emergency use authorization (EUA) for the first antigen #COVID19 test where results can be read directly from the testing card, a similar design to some pregnancy tests. https://t.co/e6DZtvxst7 pic.twitter.com/FZ0IEyPWpE
— U.S. FDA (@US_FDA) August 27, 2020
It is the second rapid test for COVID-19. Previously, the company released the ID NOW portable mini-lab, which can analyze COVID-19 in five minutes. This laboratory test was intended for clinics and other institutions, but BinaxNOW is a more of a mass product. According to the FDA, the test can be used in doctors' offices, emergency rooms, and even schools.
Frank Stich
Abbott has also developed a mobile application that provides access to and synchronization with the patient database. People who test negative for COVID-19 will receive a digital health pass through the application.
BinaxNOW refers to the type of tests that determine the patient's health status by the presence/absence of IgG antibodies to SARS-CoV-2 in their body.
BinaxNOW does a nasal swab test. The taken sample is inserted directly into the BinaxNOW card. If the result is positive, a colored strip appears on it.
In terms of accuracy, Abbott assures that the test correctly diagnoses the coronavirus infection in 97.1% of cases, while in the case of a negative result, its accuracy is even higher – 98.5%.
Tests that look for proteins, called antigen tests, tend to be less accurate than virus tests. However, some researchers argue that frequent, cheap testing with a less accurate test is the best way to control the COVID-19 pandemic.
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
By October, Abbott plans to release 50 million tests a month.
President Donald Trump plans to purchase 150 million rapid COVID-19 tests as part of a $750 million agreement with Abbott Laboratories.
