A new diagnostic test for the novel coronavirus will return results in just 45 minutes, four times faster than existing machines.
But the test, emergency use of which was cleared by the Food and Drug Administration Wednesday, will likely be used in only the most urgent situations: triaging patients who are already in the hospital or the emergency room, and testing health care workers who might be infected to see if they can return to work.
“We don’t believe this technology should be used, at least initially, in a doctor’s office,” said David Persing, chief medical officer of Cepheid, the company that developed the test. “This is not a test for the worried well.”
Cepheid, of Silicon Valley, is a unit of Danaher, the Washington, D.C.-based medical conglomerate. The test will begin shipping by the end of the week.
The announcement comes amid a dire shortage of test kits across the United States, which has hampered federal and local government officials’ ability to track the spread of the coronavirus and the respiratory disease it causes, known as Covid-19. Regulators in recent weeks have approved a rash of new testing tools developed by hospitals and commercial laboratories. The federal government also announced Thursday it had orchestrated an airlift of 500,000 swabs and sample kits needed for the tests from an Italy-based diagnostics company.
Cepheid’s test will only make a small dent in the number of diagnostic tests available for the coronavirus, known as SARS-CoV-2, or the disease it causes, Covid-19. Persing said that Cepheid will produce millions of tests over the next few months. For comparison, Thermo Fisher, another test manufacturer, has said it will be able to produce 5 million tests a week by April. LabCorp can currently conduct 20,000 tests a day, and is increasing capacity further.
But the Cepheid test plays a very different role. Other tests must be brought to a centralized lab, sometimes in a hospital but often in a geographically distant location or at a testing facility such as those owned by Quest Diagnostics and LabCorp. These other tests are run in batches, meaning that all the tests are run at once over a period of hours. That means getting a test result back can take a day — or several days.
Cepheid’s machines can run one test at a time, and can be based near an emergency room or operating room. That means doctors can get a needed result in just 45 minutes.
Nearly 5,000 Cepheid devices are already in use by hospitals and other health care providers across the country, the company said, and over 23,000 exist around the world. These devices range in capacity, Persing said, from small systems that can run two to four tests at a time to large ones that can run 80 tests using a robot arm. Most systems, he said, are somewhere in the middle, having four or 16 test modules.
Another advantage of the test is that it doesn’t require cotton swabs, which are running in short supply in some places. Doctors can use saline to aspirate fluid from the nose with a catheter instead. Still, Persing emphasized, this is not a system suited to drive-through testing efforts.
“It needs to be used very sparingly for patients who really need it and for health care workers who really need it,” Persing said.
In recent days, officials in New York, California, and other hard-hit states have urged health workers to conserve tests and the protective equipment required to administer them because they’re in short supply. In Los Angeles, city officials told doctors to test patients only if the result would dramatically alter the course of their care. The strategy is a dramatic departure from that employed by other developed nations that have been far more successful curbing the virus’ spread, like South Korea and Singapore.
“The testing is going very well,” Trump said during a White House briefing on Saturday, adding that the FDA had “moved mountains” to foster the development of new coronavirus test kits and drugs.