Abbott is launching a rapid coronavirus test able to deliver positive results in as little as five minutes from a tabletop box the size of a small toaster oven.
Weighing less than seven pounds, the company’s ID NOW diagnostic can be run just about anywhere, inside or outside of a hospital. The portable point-of-care platform has been widely used to process quick strep throat and flu tests in physicians’ offices, emergency rooms and urgent care clinics.
The FDA granted the molecular system an emergency authorization for use against COVID-19, and Abbott said it is currently ramping up production with plans to deliver 50,000 tests per day starting next week.
Abbott previously received an agency green light for a high-throughput COVID-19 test on its m2000 RealTime hardware. Between the two systems, the company said it’s aiming to produce about 5 million tests in April.
Former FDA Commissioner Scott Gottlieb described the test as a game changer on Twitter, adding that additional diagnostics for doctors' offices and point of care are “very likely” to follow.
This is GAME CHANGER. Abbott to market, starting next week, a fast point-of-care #coronavirus test, delivering positive results in 5min and negative results in 13min. Will deliver 50K tests/day to start. Kudos to Abbott and FDA’s Jeff Shuren and team at CDRH who are in the fight.— Scott Gottlieb, MD (@ScottGottliebMD) March 28, 2020
The FDA said the system can be used to test swabs directly—taken from the patient’s nose or throat straight to the machine—as well as nasal, nasopharyngeal or throat swabs stabilized in viral transport media.
At the same time, the agency granted an authorization to Luminex’s NxTAG CoV Extended panel assay, capable of processing 96 samples in four hours and detecting the novel coronavirus as well as 20 other common respiratory pathogens.