COVID-19 RAPID TESTING: EVERY MINUTE COUNTS

Point-of-care tests — given where patients show up — are critical to help fight the novel coronavirus pandemic.

COVID-19 Rapid Testing: Every Minute Counts

May 4 2020

As the world continues to combat COVID-19, one thing has become very clear: testing is critical. And to meet the global demand, different kinds of tests are needed for different purposes in different environments.

We need high-volume laboratory capabilities and lower-volume rapid tests at the point of care when a patient arrives.

Point-of-care tests — which are tests administered outside the central laboratory or at the location where the patient shows up for care — are a critical part of the diagnostic landscape to help fight the novel coronavirus pandemic.

In the case of COVID-19, point-of-care tests have become critical because of their portability, speed and reliability. Our ID NOW COVID-19 rapid point-of-care test can provide test results in 13 minutes or less. Early detection can accelerate care, reduce viral spread and help people get on the road to recovery sooner.

In use since 2014, our ID NOW molecular point-of-care platform uses an isothermal nucleic acid amplification technology to provide rapid, instrument-based, qualitative detection of infectious diseases, including influenzas A & B, strep A and respiratory syncytial virus (RSV). About the size of a toaster, it has long been hailed for its quick and accurate influenza detection. On March 27, the company received FDA emergency use authorization (EUA) to run its COVID-19 test on the ID NOW instrument.

ID NOW systems are ideally suited to be used on the front lines of the COVID-19 outbreak. Their small size (just 6.6 pounds) enables them to be easily deployed outside the four walls of a traditional hospital such as in the physicians’ office, urgent care clinics or other point-of-care locations.

"When we saw the seriousness of COVID-19, we knew we needed to develop all types of testing that could help curb the spread and support care for patients," said Chris Scoggins, senior vice president, Rapid Diagnostics, Abbott. "ID NOW instruments were already placed throughout the U.S. and being used to test for the flu and strep. We quickly pivoted to focus on developing a COVID-19 test, one that could be deployed to the front lines of this crisis."

Because of its portability and speed, ID NOW has been critical in helping to test first responders, including healthcare workers, police and fire departments.

In Detroit, officers, firefighters, paramedics and bus drivers have been given our ID NOW COVID-19 tests before starting their shifts. According to the Associated Press, before the test was available, first responders would have been sent home for days until results from slower laboratory tests showed whether they had the virus.

As we work to bring additional tests across different types of platforms to help combat this virus, point-of-care testing will continue to play a critical role in providing test results when and where patients need them most.

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.

 

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