US FDA greenlights first rapid coronavirus testing kit with 45min detection time

22nd March 2020

The test’s developer is California-based molecular diagnostics company Cepheid

America’s Food and Drug Administration (FDA) has approved the first rapid Coronavirus testing kit, reportedly with a detection time of 45 minutes.

Several American media outlets have pointed towards a huge demand in Coronavirus tests and very limited supply.

The test’s develop is a California-based molecular diagnostics company called Cepheid. On Saturday, it said it received an emergency use authorization from the FDA for the test, to be used primarily in hospitals and emergency rooms.

Cepheid added that it expects to ship to hospitals next week.

In a separate statement, the FDA confirmed it approved the test.

Reuters reports that under the current system, samples must be sent to a centralised lab, where results can take days.

“With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” U.S. Secretary of Health and Human Services Alex Azar is reported as having said on Saturday.

The diagnostic test for the virus that causes COVID-19 has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems globally, the company said.

The systems do not require users to have special training to perform testing, and can run around the clock, Cepheid President Warren Kocmond said in the statement.