On February 6, 2020, the CDC released a Laboratory Update.
- In response to the novel coronavirus (2019-nCoV) outbreak, the Secretary of Health and Human Services declared a public health emergency on January 31, 2020.
- The CDC has developed a new laboratory test kit called the CDC’s 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, for use in testing patient respiratory specimens for 2019-nCoV.
- On February 4, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to enable emergency use of the test kit in the United States.
- The FDA EUA and distribution of the tests will allow 2019-nCoV testing to take place at laboratories designated by CDC. This includes U.S. state and local public health laboratories and Department of Defense (DoD) laboratories.
- Clinical laboratories should NOT attempt viral isolation from specimens collected from 2019-nCoV persons under investigation (PUIs). For interim guidelines for collecting, handling, and testing clinical specimens from PUIs for 2019-nCoV, please see the CDC 2019 Novel Coronavirus website.