March 2020—The FDA issued an emergency use authorization for the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. This test had been limited to use at CDC laboratories; the authorization allows the use of the test at any CDC-qualified lab in the United States.
Under this EUA, the 2019-nCoV Real-Time RT-PCR Diagnostic Panel is authorized for use with patients who meet the CDC criteria for 2019-nCoV testing. Testing is limited to qualified laboratories designated by the CDC and, in the U.S., those certified to perform high-complexity tests. The test provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs.