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Emergency Use Authorization for Coronavirus Test

The US Food and Drug Administration issued an emergency use authorization for a diagnostic test from the Centers for Disease Control and Prevention for the 2019-nCoV coronavirus, as 360Dx has reported.

Prior to this, testing for 2019-nCoV had to be done at the CDC's lab in Atlanta, the Verge notes. It adds that while the test only takes between four and six hours, getting samples from state health departments to Georgia took time. With this EUA, state health departments can run the test themselves, according to the Verge.

"This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health," FDA Commissioner Stephen Hahn says in a statement. "Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test."

A positive result on the real-time RT-PCR test indicates likely infection with the coronavirus, though a negative result does not fully rule out possible infection, as 360Dx notes. It adds that, under the EUA, only patients who meet certain criteria are eligible for testing and testing may only be done by labs that are certified to perform high-complexity testing.