The Food and Drug Administration (FDA) has approved a rapid coronavirus COVID-19 test created by Cepheid, a molecular diagnostics company based in Sunnyvale, California.
“During this time of increased demand for hospital services, clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said Dr. David Persing, MD, Ph.D., chief medical and technology officer at Cepheid.
This development comes amid a dire shortage of COVID-19 test kits across the U.S. And most existing tests must be sent to a lab for processing, which can take days.
Not for everyone
For now, Cepheid’s test will be used primarily by hospitals and emergency departments. While the approval is encouraging, this news doesn’t mean anyone who wants a test can get one. “This is not a test for the worried well,” Dr. Persing said in the Washington Post. It’s a way for doctors to quickly assess patients who are already in the hospital, or to test other medical personnel suspected of being infected.
“An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources,” Dr. Persing added.
The test will begin shipping next week.
At-home coronavirus test?
While we may soon see an FDA-approved at-home test kit for COVID-19, any product currently advertised as such is a fake.
“We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19,” the FDA said on Friday. “The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”