Yesterday the Food and Drug Administration (FDA) issued an Emergency Use Authorization for the Centers for Disease Control and Prevention's (CDC's) diagnostic test kit for the novel coronavirus (2019-nCoV) that originated in Wuhan, China, paving the way for the CDC to distribute the tests, as officials confirmed Wisconsin's first case.
"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," said FDA Commissioner Stephen M. Hahn, MD, in an FDA press release. "Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test."
Today during a media briefing, Nancy Messonnier, MD, the director of the CDC's National Center for Immunization and Respiratory Diseases said the CDC's diagnostic test kits are currently en route to 100 public health labs across the country, and another 100 kits will be sent to selected international labs. Each kit contains 700 to 800 individual tests, Messonnier said.
"The availability for this test is the starting point of greater commercial testing," she said. According to the FDA, the diagnostic is a reverse transcriptase polymerase chain reaction (PCR) test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. The FDA has sent a blueprint of the test to 35 diagnostic manufacturers, Messonnier said.
Wisconsin case may involve person-to-person spread
Today Wisconsin health officials confirmed the state's first 2019-nCoV case, in Madison. The Wisconsin Department of Health Services (DHS) reported the patient was initially evaluated at the University of Wisconsin (UW) Hospitals and Clinics.
The patient is an adult isolated at home and had traveled to China before falling ill, but state health officials would not say where the patient is located, the patient's age, or any other details. The CDC confirmed the virus.
"DHS is operating with an abundance of caution and is working very closely with the local health department and UW Hospital and Clinics to ensure that this patient and any close contacts are closely monitored," said State Health Officer Jeanne Ayers, MPH, BSN, in a Wisconsin DHS news release. "The risk of getting sick from 2019 novel coronavirus in Wisconsin is very low. We are responding aggressively to the situation and monitoring all developments."
"UW Health has taken precautions, including ongoing staff training and recently expanding our travel history questions," she added.
Ryan Westergaard, MD, PhD, MPH, chief medical officer with the Wisconsin DHS Bureau of Communicable Diseases and state epidemiologist, told the Associated Press (AP) that the person who tested positive came in contact with a confirmed case while traveling to mainland China within the past 2 weeks.
The United States now has 12 cases, including 3 that are person-to-person, or secondary transmission. Nine cases have reported travel history to Wuhan.
A total of 206 suspected cases have tested negative, and Messonnier said the CDC is awaiting test results on 76 suspected cases.
"Our data indicate all 11 patients are doing well," Messonnier said before the Wisconsin information was released.
Four more planes to arrive from Wuhan
Messonier also said the CDC, in conjunction with the Department of Defense, will oversee the evacuation of four more planes from Wuhan to the United States carrying American passengers.
The planes will land in the US today and tomorrow, at four military bases in Sacramento, San Diego, San Antonia, and Omaha, Messonier said. All passengers will be placed under federal quarantine for 14 days, and regularly tested and monitored for signs of the coronavirus.
More than 800 CDC employees are working on the outbreak, including 200 who have been moved to airports and bases housing quarantined passengers.
"All of the planning we have done for a pandemic influenza is the preparation," Messonnier said. "This is the beginning of what could be a long response."
Feb 4 FDA press release
Feb 5 Wisconsin DHS news release
Feb 5 AP story