The Food and Drug Administration late Friday approved the first coronavirus test that can be conducted entirely at the point of care for a patient — and deliver results in 45 minutes.
The FDA authorization is for use in “patient care settings,” including doctors’ offices, but the test initially will be used primarily by hospitals and emergency departments, the company said.
As covid-19 cases proliferate, fears are growing that hospitals will become overwhelmed by patients seeking tests or care. David Persing, Cepheid’s chief medical and technology officer, said in an interview that the test will “help alleviate the pressure” on health-care facilities by helping doctors find out quickly whether a patient has the disease and select the appropriate treatment.
“This is not a test for the worried well,” he said, but rather a tool for doctors to quickly assess patients suspected of having covid-19.
The specimen can be collected either by a nasal swab or by a saline wash using a small catheter. Neither is particularly comfortable, but the advantage of the wash is that it doesn’t require swabs, which are in short supply, Persing said.
“We need alternative collection methods,” he added.
To further ease pressure on hospitals, the administration has said it is exploring at-home test kits. But so far, the FDA stressed Friday, it has not approved any testing at home. It warned consumers to avoid “unauthorized, fraudulent” test kits.
William Jaquis, president of the American College of Emergency Physicians, said the newly authorized test could be “extremely helpful” by reducing delays in getting results.
But he said the key to how much benefit a test like this provides depends on “how accurate it is on both positive and the negative” results.
The test, like Cepheid’s existing strep and flu tests, does not require confirmatory tests, Persing said.
The coronavirus test is designed to operate on the company’s automated GeneXpert Systems. There are about 23,000 of those systems throughout the world, of which 5,000 are in the United States, according to the company.
The firm plans to begin selling the test at the end of the month. Persing declined to say how many tests initially will be produced but said the goal is to make millions in the next few months.
