Medical device maker Abbott has received emergency authorization from the U.S. Food and Drug Administration (FDA) for its new molecular point-of-care covid-19 test, which will allow healthcare providers in a variety of different settings to obtain results almost immediately. The new test can deliver positive results in as little as five minutes and negative results in 13 minutes.
In an announcement published on Friday, Abbott said the test could be used in physicians’ offices, urgent care clinics and hospital emergency departments. It will run on the company’s ID NOW platform, a portable device the size of a small toaster that is already used to detect influenza A&B, strep A and respiratory syncytial virus. Abbott said it was ramping up production and that it is hoping to deliver 50,000 tests per day to the U.S. healthcare system beginning next week.
Per Bloomberg, Abbott’s ID NOW platform is the most commonly used point-of-care platform in the U.S., with more than 18,000 units located across the country.
To obtain results, Abbott’s molecular test uses a chemical solution to “crack open the virus,” which releases its genetic material for the ID NOW system to read. If there is even a small amount of covid-19 in the sample provided, the company explains, the ID NOW system replicates the section of the virus’ genetic material until there’s enough for detection.
The new test drastically cuts down waiting times for results, which can currently range from hours to days.
Slow testing has been one of the biggest problems in the U.S. response to the coronavirus pandemic. After a variety of missteps, which included problems with a test designed by the Centers for Disease Control and Prevention (CDC), U.S. regulators have rushed to approve commercial tests.
This isn’t the first rapid coronavirus test approved by the FDA this month. Recently, it also approved a test by molecular diagnostics company Cepheid, which can provide results in approximately 45 minutes. However, Cepheid officials say that their test is meant to be used in hospitals or emergency rooms.
In addition to its new five-minute test, recently Abbott also received FDA emergency approval for another covid-19 test that uses its m2000 RealTime system. Unlike the point-of-care test, this test is run in hospitals and laboratories. The system can process more tests daily, or up to 1 million a week according to Bloomberg, but it takes longer to get the results.
Between both systems, Abbott expects to produce about five million covid-19 tests per month.