The US Food and Drug Administration said Tuesday it has issued an emergency use authorization to allow qualified labs to use the Wuhan coronavirus test developed by the US Centers for Disease Control and Prevention. Previously, the CDC was the only lab in the United States able to test for the novel coronavirus.
The diagnostic is authorized to be used for patients who meet CDC criteria for testing, and by qualified labs designated by the CDC or certified to perform high-complexity tests.
The test can detect Wuhan coronavirus from nasal or oral swabs.
As of Monday, the CDC had 260 patients under investigation for the virus — 11 had tested positive, 167 negative and 82 were still pending.
There are 11 confirmed cases of the novel coronavirus in the United States. Six cases have been confirmed in California, one in Massachusetts, one in Washington state, one in Arizona and two in Illinois.
Negative results do not preclude infection with the virus, the FDA noted in a press release, adding that negative results must be combined with clinical observations, patient history and epidemiological information.
“Since this outbreak first emerged, we’ve been working closely with our partners across the US government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible. 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 Dr. Stephen Hahn said in a statement.
The US Department of Health and Human Services on Friday declared the novel coronavirus to be a public health emergency in the United States.