Abbott Laboratories announced Friday that the U.S. Food and Drug Administration (FDA) approved the emergency use of its new Abbott ID NOW COVID-19 test that delivers positive results in five minutes and negative results in 13 minutes.
The medical device, which is about the size of a toaster and weighs nearly 3 kg, is portable and can be set up anywhere, from a physician’s office to an urgent care clinic, according to the company’s press release.
The Abbott ID NOW COVID-19 molecular test detects the presence of nucleic acid from SARS-CoV-2 by "identifying a small section of the virus' genome, then amplifying that portion until there's enough for detection."
Chris Scoggins, Senior Vice President of Rapid Diagnostics at Abbott said the company expects to deliver 50,000 COVID-19 tests per day to the U.S. healthcare professionals, adding that "portable molecular testing expands the country's capacity to get people answers faster."
The company said the tests will be available beginning on April 1.
The FDA also approved Abbott's m2000 RealTime system for coronavirus detection this month. Combined with ID NOW, Abbott expects to produce about 5 million tests in April.
ID NOW also has uses outside of COVID-19 testing as it can be used to test for Influenza A&B, Strep A and respiratory syncytial virus (RSV), according to Abbott.
However, Abbott noted that ID NOW COVID-19 Emergency Use Authorization (EUA) is not FDA cleared or approved, meaning it can only be used by authorized laboratories and patient care settings.
According to the World Health Organization, the U.S has over 100,000 confirmed cases of coronavirus infection with more than 1,600 fatalities related with the virus.
The US Centers for Disease Control and Prevention (CDC) says that while not everyone needs to be tested and it has specific guidelines to determine who should be tested, results can still mean more than knowing whether or not one has been infected. “Testing results may be helpful to inform decision-making about who you come in contact with.”