At the end of March, the American medical devices and healthcare company Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the fastest available molecular point-of-care COVID-19 test, finalising results in only a few minutes.
The molecular point-of-care COVID-19 test could be a gamechanger
The Abbott ID NOW™ COVID-19 test provides an opportunity for rapid frontline monitoring. Should these tests be quickly deployed and prove a high level of clinical accuracy, this could fundamentally change how the ongoing pandemic ultimately plays out.
COVID-19 test results ready in 5 minutes
ID NOW coronavirus test is a speedy, instrument-based, isothermal device designed to detect infectious diseases qualitatively. Its innovative isothermal nucleic acid amplification technology delivers molecular results in as little as five minutes and negative outcomes in 13 minutes, allowing physicians to make clinical choices based on evidence during a patient visit.
A mobile instrument that can be used in a variety of healthcare settings
What makes this test so different is that it can be used outside of a traditional hospital to perform rapid tests in a wide variety of healthcare environments, such as health care facilities, physicians offices, urgent medical centres, and emergency departments.
Abbott’s molecular point-of-care COVID-19 test will run on the company’s proprietary ID NOW™ platform. The ID NOW device is compact, lightweight (6.6 pounds) and mobile (the size of a medium toaster), and uses molecular science, respected for its high degree of precision by physicians and the medical community. Currently, ID NOW is the most widely available molecular point-of-care testing tool for COVID-19 in the United States.
Robert B. Ford, president and chief operating officer, Abbott 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.”
Abbott to manufacture 50,000 ID NOW molecular point-of-care COVID-19 tests per day
The U.S based company is accelerating production to deliver 50,000 ID NOW COVID-19 tests per day, beginning next week.
Abbott plans to make ID NOW COVID-19 tests available to healthcare providers in intensive care facilities in the U.S., where most ID NOW devices are currently in use. The company is partnering with the U.S. Administration to launch tests in places where they will have the greatest benefit.
This is the second test for the company to receive Emergency Use Authorization from the FDA for COVID-19 monitoring. The release of Abbott’s ID NOW COVID-19 test comes a week after the medical device company launched the Abbott m2000™ RealTime SARS-CoV-2 EUA test working on the RealTime m2000™platform installed in hospitals and research laboratories around the world. Abbott plans to manufacture about 5 million tests a month between the two projects.
Currently, the U.S. has the highest number of confirmed COVID-19 cases in the world—surpassing 300,000. The worldwide confirmed case count is now more than 1 million.
More about the ID NOW™ Molecular Platform
As the world pioneer in point-of-care diagnostics, Abbott is applying its experience and scope to help combat the worldwide COVID-19 pandemic. ID NOW was first launched in 2014 and is the leading molecular point-of-care tool for Influenza A & B, Strep A, and RSV research in the United States.
The regulatory status of Abbott’s COVID-19 test
It is noteworthy, that the ID NOW COVID-19 was neither cleared nor approved by the FDA. It has been authorised by the FDA for use by certified laboratories and patient care facilities under an emergency use authorisation.
The testing method has been approved specifically for the detection of SARS-CoV-2 nucleic acid, not for any other viruses or pathogens, and is only approved for the length of the declaration where there are circumstances supporting the authorisation for the emergency use of in vitro diagnostic tests for the identification and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bb-3(b)(1), except as provided for in Article 564(b)(1).
Other rapid COVID-19 tests in development
In the UK, two companies, in particular, stand out for their rapid COVID-19 testing devices. SureScreen Diagnostics and Mologic have developed rapid COVID-19 test kits and both are currently in the process of trialling their tests. Similarly to Abbott, the companies devices can show results within minutes and can be used in a variety of environments, but unlike Abbott’s molecular test device, the two British companies have based their rapid testing technology on detecting antibodies.