Abbott Laboratories unveils a coronavirus test that can detect if someone is infected in as little as five minutes. It is so small and portable that it can be used in almost any health care setting.
The medical device maker plans to provide 50,000 tests a day starting April 1, said John Frels, vice president of research and development at Abbott Diagnostics. Molecular testing looks for fragments of the coronavirus genome, which can be quickly detected when present at high levels. Thorough research to definitively rule out an infection can take up to 13 minutes, he said.
Abbott has received emergency use authorization from the United States Food and Drug Administration “for use by licensed laboratories and patient care facilities,” the company said on Friday.
The U.S. has struggled to provide enough tests to detect the virus, although the epidemic threatens to overwhelm hospitals in New York, California, Washington, and other regions. After initially restricting testing to high-risk people and encountering problems with a test designed by the Centers for Disease Control and Prevention, U.S. regulators have rushed diagnostics by the world’s largest commercial testing companies.
“This will really provide a tremendous opportunity for frontline caregivers, those who have to diagnose many infections, to bridge the gap with our tests,” said Frels. “A clinic can quickly reverse this result while the patient waits.”
The technology builds on Abbott’s Illinois-based ID Now platform, the most common point-of-care test currently available in the United States, with more than 18,000 units distributed across the country. It is widely used to detect influenza, strep throat and respiratory syncytial virus, a common insect that causes cold symptoms.
The test starts with taking a swab from the nose or back of the throat, then mixing it with a chemical solution that breaks the virus and releases its RNA. The mixture is inserted into an ID Now system, a small box weighing just under 7 pounds which has the technology to identify and amplify certain sequences of the coronavirus genome and ignore contamination by other viruses. The equipment can be installed almost anywhere, but the company is working with its customers and the Trump administration to ensure that the first cartridges are sent where they are most needed. They target hospital emergency rooms, emergency care clinics and doctor’s offices.
Abbott’s m2000 RealTime system last week received approval from the U.S. Food and Drug Administration for use in hospitals and molecular laboratories to diagnose infection. This system can produce more tests daily, up to 1 million per week, but it takes more time to get the results.