The FDA has just issued an emergency use authorization for the Cepheid Xpert Xpress SARS-CoV-2 test, a new point of care diagnostic to detect the coronavirus that causes COVID-19.
The FDA said the test can reportedly produce results within hours, not days, however the manufacturer Cepheid said the test will take approximately 45 minutes.
“The test can provide rapid detection of the current pandemic coronavirus SARS-CoV-2 in approximately 45 minutes with less than a minute of hands on time to prepare the sample,” according to the company’s website.
The company plans to roll-out availability of the point-of-care test beginning next week according to the company, or by March 30, according to the FDA. The FDA called it “an incredibly rapid timeline for such an effort.”
“This new test is honestly a potential game changer for us,” Dr Megan Rainey, an emergency physician at Lifespan/Brown University, told CNN’s Wolf Blitzer. “My emergency department, like hospitals across the country, are increasingly filled with patients with symptoms that seem like coronavirus — but we can’t test.”
Dr. Rainey explained currently they are making decisions to either hospitalize or send home patients without the benefit of testing.
“It would be so transformative to be able to actually test patients the same way we do for flu or other illnesses. To be able to tell people they should actually quarantine and to be able to make decisions to save equipment for the patients that we do have to hospitalize,” she said.
The new test was approved the same day that some health officials in New York and Los Angeles have advised hospitals to not test all potential patients but to save tests for healthcare workers and hospitalized patients. According to the Philadelphia Inquirer, LA County health officials are advising a shift from containment strategy to a strategy to slow transmission and reduce morbidity/mortality.
“Not every single person in the United States needs to get tested,” NIAID director Anthony Fauci said at Saturday’s daily briefing of the White House Coronavirus Task Force. One of the unintended consequences of a flood of individuals getting tested is, he said, consuming PPE equipment. “When you go in and get tested you are consuming personal protective equipment, masks and gowns, those are high priority for the healthcare workers who are taking care of people who have coronavirus disease.”