FDA has issued an emergency use authorization (EUA) to diagnostics manufacturer Abbott, Abbott Park, Ill, for the company’s ID Now SARS-CoV-2 molecular diagnostic.
The new test is the fastest available molecular point-of-care test for the diagnosis of novel coronavirus disease (covid-19), delivering positive results in as little as 5 minutes and negative results in 13 minutes. The test 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 platform is a rapid, instrument-based system for the qualitative detection of infectious diseases. The platform is small, lightweight (6.6 pounds), and portable (the size of a small toaster). Its unique isothermal nucleic acid amplification technology provides molecular results in just minutes. The analyzer’s molecular technology enables clinicians to make evidence-based clinical decisions during a patient visit, and is valued by clinicians and the scientific community for its high degree of accuracy. ID Now is currently the most widely available molecular point-of-care testing platform in the United States.
“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,” says Robert B. Ford, president and chief operating officer at 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.”
Abbott has begun making ID Now covid-19 tests available to healthcare providers in urgent care settings in the United States, where the majority of ID Now instruments are in use today. The company is working with the federal government to deploy tests to areas where they can have the greatest impact.
Arrival of the Abbott 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. Between the two platforms, Abbott expects to produce about 5 million tests per month.
For further information, visit Abbott.
Featured image: Testing being performed on Abbott’s ID Now platform. Photo courtesy Abbott.