ID NOW is one of the most widely-available molecular point-of-care testing technologies in use in the U.S. Since its introduction in 2014, it has been used in physicians' offices and urgent care centers to rapidly detect influenzas A & B, strep A, and respiratory syncytial virus (RSV). When faced with the threat of novel coronavirus, our scientists mobilized to quickly bring a new COVID-19 detection test to the fight against this deadly virus.
Because of its ease of use, portability and rapid results, ID NOW is providing frontline healthcare workers with a tool that they hoped for when the COVID-19 pandemic first took hold across the world. Rapid tests are part of the equation along with high-volume lab-based tests to identify patients with active infections. ID NOW is an FDA approved CLIA-waived instrument, which means that the technology can be used in settings outside the traditional hospital setting. Healthcare professionals using ID NOW should be trained on how to use the instrument.
ID NOW uses isothermal technology, proprietary enzymes and constant temperature control to achieve the fastest available RNA amplification. This proven molecular system greatly reduces the time for results, allowing healthcare providers to make patient care decisions sooner.
To conduct a test, a swab of the nose is taken. Then the swab is placed into an acidic liquid solution heated to 132.8⁰ F that cracks open the envelope of the SARS-CoV-2 virus, exposing its viral RNA.
Then the small device, about the size of a toaster and weighing only 6.6 pounds, amplifies the RNA hundreds of millions of times to make the virus detectable — returning test results in 13 minutes or less.
"ID NOW is at the forefront of molecular testing technology because of the isothermal process by which the virus is quickly extracted and magnified at a constant temperature," said John Hackett Jr., Ph.D., divisional vice president of applied research and technology for Abbott's Diagnostics business. "This technology is so important when testing in hotspots and in 'de-centralized' healthcare settings, where sometimes the lab isn’t an option."
ID NOW has quickly become an important tool in the fight against COVID-19 outside of traditional hospital settings.
- Some hospitals use it to test patients before surgery.
- People who need chemotherapy and are behind in their treatments are now able to be tested quickly so they can get back to the hospital to continue on their journey to recovery.
- Urgent care centers and pharmacy clinics are using the test in point-of-care sites throughout the country.
The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.