U.S. FDA expands use of CDC coronavirus diagnostic test
The U.S. Food and Drug Administration on Tuesday extended the use of a coronavirus detection tool to Centers for Disease Control and Prevention (CDC)-qualified laboratories across the country. The authorization was until recently limited to CDC laboratories.
Under the emergency use authorization, the 2019-nCoV Real-Time RT-PCR diagnostic panel can be used in patients who meet the CDC criteria for coronavirus testing. "Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions," the FDA said.
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