Abbott receives FDA emergency use authorisation for new Covid-19 test

30 March 2020 (Last Updated March 30th, 2020 11:01)

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Abbott’s new molecular point-of-care test to detect coronavirus (Covid-19).

Abbott receives FDA emergency use authorisation for new Covid-19 test
Testing is performed on Abbott’s ID NOW platform. Credit: Abbott.

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The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Abbott’s new molecular point-of-care test to detect coronavirus (Covid-19).

The latest test runs on the company’s ID NOW platform and delivers positive results in five minutes and negative results within 13 minutes.

The ID NOW platform is a rapid, instrument-based, isothermal system used for the qualitative detection of infectious diseases.

Its isothermal nucleic acid amplification technology enables molecular results in minutes. Furthermore, it is small, lightweight and portable.

Abbott president and chief CEO Robert Ford said: “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.

“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.”

The company said it expects to scale up manufacturing to deliver 50,000 tests per day to meet the current demand for coronavirus tests. The ID NOW Covid-19 test will be launched next week.

It is the second EUA secured by Abbott for Covid-19 detection. The company received its first EUA for RealTime SARS-CoV-2 test from the US FDA this month.

RealTime SARS-CoV-2 is another molecular test for Covid-19 that runs on its m2000 RealTime System.

Combining both its Covid-19 tests, Abbott plans to deliver approximately five million tests per month to keep up with the diagnosis requirements.

Meanwhile, 143,025 confirmed coronavirus cases have been reported in the US. The death toll has reached over 2,509 in the country.