The Food and Drug Administration (FDA) issued an Emergency Use Authorization on February 4, 2020, 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.
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.
In related news, 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.
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 two weeks.
The United States now has 12 cases, including three 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.
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 U.S. at four military bases in Sacramento, San Diego, San Antonio 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."