Abbott Labs’ 5-minute portable coronavirus test gets US FDA approval

American healthcare firm Abbott Laboratories has won the US Food and Drug Administration approval for a portable COVID-19 testing kit which can deliver a result in as little as five minutes. 

The Abbott ID NOW COVID-19 test has the largest molecular point-of-care installed base in the US and is available in a wide range of healthcare settings such as physicians’ offices, urgent care clinics and hospital emergency departments, the company said. 

Abbott announced that the FDA has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes.

With a weight of 6.6 pounds and the size of a small toaster, the ID NOW platform is small, lightweight and portable and uses molecular technology.

“The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus,” said Robert B Ford, president and chief operating officer, Abbott. 

“With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots,” he said. 

The company said it will be making ID NOW COVID-19 tests available next week to healthcare providers in urgent care settings in the US. The company is working with the Administration to deploy tests to areas where they can have the greatest impact, it said.  

This is the company’s second test to receive Emergency Use Authorization by the FDA for COVID-19 detection. 

This comes a week after the company launched its Abbott m2000™ RealTime SARS-CoV-2 EUA test, which runs on the m2000™ RealTime System located in hospital and reference labs around the world. 

Abbott will be making ID NOW COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day. Between the two platforms, Abbott expects to produce about 5 million tests per month.

Abbott’s ID NOW, introduced in 2014, is the leading molecular point-of-care platform for Influenza A & B, Strep A and RSV testing in the US, the company said. 

This comes as the number of coronavirus cases in the US keep rising and has crossed one 100,000-mark. As per the John Hopkins University’s coronavirus database, the number of confirmed COVID-19 cases in India stand at 104,829 while 1,711 have died. 

Back to top button