Abbott announced it has received the United States Food and Drug Administration’s Emergency Use Authorisation (EUA) for its rapid, portable, point-of-care molecular test for the detection of novel coronavirus (COVID-19).
The test, called ID NOW COVID-19, delivers positive results in as little as five minutes and negative results in 13 minutes, Abbott said.
Abbott said it makes the tests available next week to healthcare providers in urgent care settings in the US, where the majority of ID NOW instruments are in use today.
At the moment Abbott’s testing will be confined to the US, but given the urgency of the situation, it could be a matter of weeks before it is available in other countries including India.
Abbott’s testing kit will be a major game-changer, as currently even in advanced countries such as the US and Europe, it is taking 24-48 hours to get a laboratory test done. The process testing is an expensive and time-consuming process that involves a phlebotomist going for the collection of a swab sample, then processing the sample in the lab through RT-PCR testing.
The Abbott test, on the contrary, will run on the company’s ID NOW platform, providing rapid results in a wide range of healthcare settings such as physicians’ offices, urgent care clinics, and hospital emergency departments.
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 the hospital and reference labs around the world.
Between the two platforms, Abbott expects to produce about 5 million tests per month.
The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is valued by clinicians and the scientific community for its high degree of accuracy.
“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 Abbott’s point of care healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots.
The company said it working with the US government to deploy tests to areas where they can have the greatest impact.
First introduced in 2014, ID NOW is the leading molecular point-of-care platform for Influenza A & B, Strep A and RSV testing in the US. The rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. Its unique isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing clinicians to make evidence-based clinical decisions during a patient visit.