Coronavirus pandemic: FDA approves diagnostic test that can detect virus in 15 minutes
The FDA has only approved the test for emergency use by approved labs and healthcare providers and has not been cleared or approved for regular use
The US Food and Drug Administration (FDA) has greenlighted a 15-minute coronavirus test that can be deployed in physicians' offices, urgent care clinics and hospitals across the country.
Developed by Abbott Laboratories, the tests takes about five minutes for positive results and 13 minutes for negative ones. Additionally, it is expected to strengthen the company's testing capacity. "This is a significant leap forward,” John Frels, vice president of research and development at Abbott, said in an interview with Reuters. The test detects the virus's genetic material, similar to the CDC's test.
The FDA has only approved the test for emergency use by approved labs and healthcare providers and has not been cleared or approved for regular use, the company said.
With this, it becomes the second such test to be approved by the FDA. Only last week, the federal agency had approved a 45-minute coronavirus test developed by Cepheid, a molecular diagnostic company based in California.
Starting next week, Abbott is expected to deliver 50,000 tests per day. The test will run on the company's platform, which compares to the size of a small toaster. Weighing only 6.6 pounds, it is portable. Earlier, it had used the same platform to detect Influenza A & B testing in the US.
"The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus,” said Robert Ford, president, and chief operating officer at Abbott, in a statement.
These tests could offer some respite. The US is leading the world in the number of confirmed cases. With more than 100,000 people sickened, the country's resources are under tremendous strain. On March 27, Vice President Mike Pence said more than 685,000 tests for the virus had been performed.
But the US is experiencing a shortage of personal protective equipment such as masks and swabs, which are used by health workers to safely collect patient samples.
To help with this, the Centers for Disease Control and Prevention (CDC) has put forth new guidelines that allow patients to collect their own nasal swabs in health care facilities.