FDA Approves First Rapid COVID-19 Test

By Vanessa Romo

Published March 21, 2020 at 5:38 PM CDT

The Food and Drug Administration has approved the first rapid point-of-care COVID-19 test, that can deliver results in less than an hour.

Cepheid, a Silicon Valley diagnostics company, made the announcement on Saturday, saying it has received emergency authorization from the government to use the test.

While the agency has approved about a dozen other COVID-19 tests in response to the public health emergency caused by the coronavirus pandemic, this is the first one that can be used at the point of care.

Cepheid said the test kits will be available by the end of the month.

Until now, to get test result, a health care worker would take a swab from the back of a person's nose, and send it off to a public health, commercial or hospital lab, or to a lab at the Centers for Disease Control and Prevention in Atlanta. The process can take days.

The newly approved test kit still involves taking a nasal swab, but the test can be done in a doctor's office or clinic with a detection time of approximately 45 minutes, according to Cepheid.

"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, chief medical and technology officer at Cepheid.

He added: "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."

State and local government leaders have been putting pressure on the Trump administration and the coronavirus task force led by Vice President Mike Pence to address widespread testing shortages. In response, the administration has turned to the private sector to help develop tests, vaccines and therapeutic medicines to help stem the pandemic.

On Saturday, Pence confirmed more than 195,000 people have been tested for the respiratory virus, not including those who were tested in county hospitals or health care labs around the nation. Of those, roughly 19,350 have tested positive for the coronavirus.