Abbott Labs’ 5-Minute COVID-19 Test Gets FDA Approval

The test is carried out on a device that weighs less than seven pounds and can deliver a positive COVID-19 result in as little as five minutes.

Written by Ellen Glover
Published on Mar. 30, 2020
Chicago-based Abbott Labs got its quick coronavirus test approved by the FDA
Photo: Abbott Labs

The Food and Drug Administration has approved emergency use of a molecular test that can diagnose the novel coronavirus in a matter of minutes. The device was developed by Illinois-based pharmaceutical company Abbott Labs and runs on the company’s ID NOW platform.

Right now, patients can wait days or even weeks to get COVID-19 test results. But Abbott says its instrument can display positive results in five minutes and negative results in 13 minutes. Plus, weighing less than seven pounds, the device can be used outside of a hospital.

“ID NOW is mobile and can be brought to places of greatest need – the instrument could be used in a remote, portable environment — including non-traditional sites like drive-thru testing facilities or airports, making ID NOW an important new tool in the broader comprehensive testing effort,” Dr. Norman Moore, Abbott’s director of infectious diseases and scientific affairs, told Built In. “It’s meant to provide an option beyond the hospital or reference laboratories that are able to test very high volumes.”

Here’s how it works: A sample swab is taken from a person’s nose or the back of their throat and is mixed into a chemical solution, which breaks open the virus and releases its genetic material. When ID NOW analyzes the sample in the solution, it is able to recognize a unique section of the coronavirus genome, which is then safely replicated inside the instrument to make the virus detectable. Results are then displayed right on the device’s screen.

Before now, the ID NOW was primarily used to diagnose things like influenza and strep throat, so Abbott says many doctor’s offices, urgent care clinics and hospitals around the country already have it. The company says it will be able to deliver another 50,000 tests a day beginning April 1.

While Moore did not specify where the company would be distributing these devices specifically, Illinois Governor J.B. Pritzker said during a coronavirus news conference on Sunday that Abbott officials have “expressed their real dedication to taking care of their home state” when production ramps up.

Illinois has more than 5,000 confirmed COVID-19 cases and Chicago has been named as a national hotspot for the virus, so this quick test could prove crucial going forward.

“Molecular point-of-care testing on the ID NOW instrument allows immediate access to where patient testing is needed most, taking the fight to the front lines and freeing up valuable time and resources for public-health officials and healthcare providers,” Moore said.

The company’s testing achievement received another signal boost on Sunday, when President Donald Trump mentioned Abbott Labs during the White House’s daily coronavirus briefing. Trump praised the company's “incredible work.”

Abbott Labs cautioned in its press release that, while ID NOW has received emergency-use authorization from the FDA, that does not mean it has gotten total FDA approval for its testing.

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