FDA approves test that would detect coronavirus in 5 minutes, report

Marco Green
March 30, 2020

President Donald Trump announced the development of a new test kit for COVID-19 that can produce results in five minutes.

The device, which Abbott claims is the "fastest available molecular point-of-care test" for the detection of COVID-19, is its second test to receive emergency use authorization by the FDA.

Abbott Laboratories said the device is small and portable - about the size of a toaster - and can be set up outside hospitals, for instance.

The company, in a statement, said that it will be making ID NOW, a portable instrument that can be deployed where testing is needed most, COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day. The company noted the platform is already "the most widely available molecular point-of-care testing platform" used in the USA today. If there is even a small amount of covid-19 in the sample provided, the company explains, the ID NOW system replicates the section of the virus' genetic material until there's enough for detection.

The new test drastically cuts down waiting times for results, which can now range from hours to days.

This comes as the number of coronavirus cases in the U.S. keep rising and has crossed one 100,000-mark. After a variety of missteps, which included problems with a test designed by the Centres for Disease Control and Prevention (CDC), U.S. regulators have rushed to approve commercial tests.

Last week, the FDA approved a test made by Cepheid that can be used at the point of care. The molecular test takes as little as five minutes, while a more thorough search to definitively rule out an infection can take up to 13 minutes, he said. The typical time from securing a patient swab to obtaining positive or negative results using now available tests is one to four days.

The ID NOW COVID-19 test 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.

FDA Commissioner Steve Hahn said he's pleased that Abbott's point-of-care test had been authorized.

With three units of this device, Nigeria can run more tests in one day than it had run in four weeks.

Abbott will be able to provide 50,000 tests by April 1 and will be able to provide 1 million per month of this test, Moore said.

Other reports by Click Lancashire

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