FDA Issues Emergency Authorization on Game-Changing 5-Minute COVID-19 Test
The U.S. Food and Drug Administration has granted emergency-use authorization to the fastest available test for the detection of the coronavirus.
The test, created by Abbott Laboratories, can detect if someone has COVID-19 in five minutes, according to a media release from the company.
The Abbott ID NOW COVID-19 test runs on Abbott’s ID Now platform in a small, lightweight box, making it easy to carry to different locations for testing and to generate results in just a few minutes.
The test is conducted by taking a swab from the nose or back of the throat and then mixing it with a chemical solution to break open the virus to release its RNA, according to Bloomberg.
The sample is then placed into the ID Now system and it looks for pieces of the COVID-19 genome. The test produces negative results in 13 minutes and positive results in 5 minutes.
Abbott released this short video to explain the process of molecular testing:
“This is really going to provide a tremendous opportunity for front-line caregivers, those having to diagnose a lot of infections, to close the gap with our testing,” Abbott’s vice president of research and development John Frels said.
“A clinic will be able to turn that result around quickly, while the patient is waiting.”
The technology has been granted emergency-use authorization by the FDA “for use by authorized laboratories and patient care settings,” according to the media release.
Although the tests can be set up anywhere, the company is working with the Trump administration to make sure the first tests are sent where they are needed the most.
“Through the incredible work of teams across Abbott, we expect to deliver 50,000 COVID-19 tests per day to healthcare professionals on the front lines, where testing capabilities are needed most,” rapid diagnostics senior vice president Chris Scoggins said. “Portable molecular testing expands the country’s capacity to get people answers faster.”
The company says it will begin supplying 50,000 ID NOW COVID-19 tests daily on April 1.
This is GAME CHANGER. Abbott to market, starting next week, a fast point-of-care #coronavirus test, delivering positive results in 5min and negative results in 13min. Will deliver 50K tests/day to start. Kudos to Abbott and FDA’s Jeff Shuren and team at CDRH who are in the fight.
— Scott Gottlieb, MD (@ScottGottliebMD) March 28, 2020
Abbott also received emergency-use authorization last week on its Abbott RealTime SARS-CoV-2 assay test for use in clinical laboratories.
The company expects to produce about 5 million of both tests a month, according to another news release.
“Testing remains a crucial step in controlling the novel COVID-19 pandemic,” the company said. “Continuing to supply healthcare providers with new technologies to help curb the spread of infection is a top priority for public health officials and healthcare providers.”
As of Saturday morning, there were over 621,000 confirmed cases of coronavirus around the world, over 100,000 of those in the United States, according to information from Johns Hopkins.
The total number of worldwide deaths from the disease was approaching 30,000, while nearly five times that many were considered to have recovered.
The Trump administration issued guidelines on March 16 intended to slow the spread of coronavirus, but the 15-day time frame of those guidelines expires at the end of the month. Additional guidelines are expected from the Trump administration soon, which will be based on the level of risk in each American county.
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