FDA issues emergency authorization for CDC novel coronavirus test kits

The Food and Drug Administration late yesterday issued an emergency use authorization allowing qualified public health labs to use the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel, previously only available at CDC laboratories. Two hundred kits are being shipped to CDC-qualified state and local U.S. public health labs and another 200 to select international labs, with each kit able to test 700-800 patient samples. 

The Department of Health and Human Services and CDC today said four flights carrying passengers from Wuhan, China, will land today and tomorrow in California, Texas and Nebraska, and all passengers will undergo the mandatory 14-day quarantine. U.S. confirmed cases remained at 11, while the World Health Organization reported 24,554 global cases and nearly 500 deaths. 

“We’re aggressively intervening to contain introduction [of the virus] in the United States,” said Nancy Messonnier, M.D., director of CDC’s Center for the National Center for Immunization and Respiratory Diseases. 

WHO today requested $675 million for a strategic preparedness response plan and is sending masks, gloves, respirators and gowns to at least 24 countries to aid in their response. 

Messonnier asked that personal protective equipment be used appropriately but not excessively to ensure enough supplies if the virus spreads, especially for health care workers. 

CDC will host a series of calls with state and local partners starting Monday, Feb. 10, at 2 p.m. ET. To participate, call 1-800-857-6697, passcode 1324420. CDC today also issued updated public health response and interim clinical guidance. For the latest information and resources, visit AHA’s coronavirus webpage.