One week after the FDA granted emergency approval to a point-of-care test purporting to produce results in under 45 minutes, the agency has granted "emergency use authorization" to Abbott Labs so the company can bring to market a rapid-response test for COVID-19 that can tell if somebody is infected in under five minutes, and is portable enough to be used in practically any health-care setting.
The medical-device maker plans to supply 50,000 tests a day beginning April 1, said John Frels, vice president of research and development at Abbott Diagnostics. The molecular test scans samples for fragments of the coronavirus genome, which can quickly be detected when present at high levels. An even more thorough search to definitively rule out an infection can take up to 13 minutes, BBG reports.
However, the FDA has only authorized the test for use in "authorized laboratories and patient care settings", mostly hospitals and approved public and private labs that are already running tests.
The company described the test as a "gamechanger."
"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," Frels said. "A clinic will be able to turn that result around quickly, while the patient is waiting."
Here's how the test works, according to Bloomberg:
The technology builds on Illinois-based Abbott’s ID Now platform, the most common point-of-care test currently available in the U.S., with more than 18,000 units spread across the country. It is widely used to detect influenza, strep throat and respiratory syncytial virus, a common bug that causes cold-like symptoms.
The test starts with taking a swab from the nose or the back of the throat, then mixing it with a chemical solution that breaks open the virus and releases its RNA. The mixture is inserted into an ID Now system, a small box weighing just under 7 pounds that has the technology to identify and amplify select sequences of the coronavirus genome and ignore contamination from other viruses.
The equipment can be set up almost anywhere, but the company is working with its customers and the Trump administration to ensure the first cartridges used to perform the tests are sent to where they are most needed. They are targeting hospital emergency rooms, urgent-care clinics and doctors’ offices.
Last week, Abbott’s m2000 RealTime system got U.S. Food and Drug Administration approval for use in hospitals and molecular laboratories to diagnose the infection. That system can churn through more tests on a daily basis, up to 1 million a week, but it takes longer to get the results. Abbott plans to provide at least 5 million tests a month between the two systems.
Other companies are also rolling out faster testing systems as "point-of-care" becomes the critical buzzwords - tests that can be marshaled to test patients at bedsides in ad-hoc treatment environments like the Javits Center.
The seemingly miles of beds being set up at Javits. It is absolutely unreal to see what the National Guard & first responders have put together here in just days. pic.twitter.com/dD0AQg4PO4— Sarah Boxer (@Sarah_Boxer) March 27, 2020
Henry Schein Inc. on Thursday said its point-of-care antibody test, which looks for evidence that a person’s immune system has already fought off the infection, was available. The blood test can be given at the point of care and delivers results in about 15 minutes, though it can’t be used to definitively diagnose a current infection.
The breakthrough comes as the left bashes President Trump for falsely claiming that the US has conducted more tests for COVIDd-19 than any other nation, when South Korea, Italy and China have all run far more tests per capita.