The U.S. Food and Drug Administration (FDA) has granted Abbott Laboratories its Emergency Use Authorization (EUA) for Abbott's new portable “rapid” coronavirus test kits.
The North Chicago-based medical device maker made the announcement on Friday, March 27.
Abbott Laboratories claims that its new technology is the fastest molecular point-of-care test kit.
The lab says the test kit can detect the nucleic acid from the SARS-CoV-2 pathogen, the cause of coronavirus disease 2019 (COVID-2019), in as little as 5 minutes.
The company also says that negative results can be delivered within 13 minutes.
The tests are done through a cartridge inserted in the company’s ID NOW system, a portable box that weighs 6.6 lbs. and uses molecular technology to identify and amplify select sequences of the coronavirus genome.
ID NOW is also widely used to detect Influenza A&B, Strep A, and respiratory syncytial virus (RSV).
In its statement, Abbott says its rapid test kit “can be used in more non-traditional places where people can have their results in a matter of minutes, bringing an alternate testing technology to combat the novel coronavirus.”
Abbott’s ID NOW COVID-19 tests will be available starting next week.
The company is now ramping up production to meet unprecedented demand.
Chris Scoggins, senior vice president for Rapid Diagnostics, says: "Through the incredible work of teams across Abbott, we expect to deliver 50,000 COVID-19 tests per day to healthcare professionals on the front lines, where testing capabilities are needed most. Portable molecular testing expands the country's capacity to get people answers faster."
Abbott Laboratories notes that its new rapid test for COVID-19 has not been cleared or approved by the U.S. FDA.
Therefore, at this time the test kit is only authorized for emergency use by approved labs and healthcare providers.
With more than 100,000 confirmed cases of COVID-19, the United States is now the epicenter of the global pandemic.
At press time, the Philippines currently has 803 confirmed afflicted, of whom 54 have died and 31 have recovered.