Medical equipment manufacturer Abbott has been granted an emergency permit for its new molecule from the U.S. Food and Drug Administration (FDA) point-of-care covid-19 test, enabling practitioners in various settings to achieve results almost immediately. The new test can produce positive results within five minutes and negative results within 13 minutes.
In an announcement published on Friday, Abbott said the test can be used in doctor’s offices, emergency clinics, and hospital emergency departments. It runs on the company’s ID NOW platform, a portable appliance the size of a small toaster already used to detect influenza A&B, strep A and respiratory syncytial virus. Abbott said it boosted production and that it hopes to deliver 50,000 tests a day to the U.S. healthcare system starting next week.
Per Bloomberg, Abbott’s ID NOW platform is the most widely used point-of-care platform in the United States, with more than 18,000 units located across the country.
To obtain results, Abbott’s molecular test uses a chemical solution to ‘break open the virus’, releasing the 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 portion of the genetic material of the virus until there is enough for detection.
The new test drastically reduces waiting times for results, which is possible currently vary from hours to days.
Slow testing is one of the major problems in the US response to the coronavirus pandemic. After several missteps, including problems with a test designed by the Centers for Disease Control and Prevention (CDC), U.S. regulators have hastened to approve commercial tests.
This isn’t the first rapid coronavirus test approved by the FDA this month. Recently it also approved a test from molecular diagnostics company Cepheid, which can produce results in about 45 minutes. Cepheid officials, however, say their test is intended to be used in hospitals or emergency rooms.
In addition to the new five-minute test, recently Abbott also received FDA emergency approval for another covid-19 test using his m2000 RealTime system. Unlike the point-of-care test, this test is performed in hospitals and laboratories. The system can handle more tests daily, or up to 1 million a week according to Bloombergbut it takes longer to get the results.
Between the two systems, Abbott expects to produce about five million covid-19 tests per month.