02/08/2020: Lab Update: Updated Information about the Emergency Use Authorization for the CDC 2019-nCoV RT-PCR Diagnostic Panel
Audience: Clinical Laboratory Professionals
Level: Laboratory Update
Updated Information about Emergency Use Authorization for CDC 2019-nCoV RT-PCR Diagnostic Panel
Please note that, even though the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, public health laboratories will not be immediately ready to test for nCoV until they complete their test performance verification processes.
For more information, see the joint communication issued by the Association of Public Health Laboratories (APHL) and the Council of State and Territorial Epidemiologists (CSTE).
Formerly, U.S. diagnostic testing for 2019-nCoV was only conducted at CDC. However, with the EUA determination and the pursuant distribution of the tests, 2019-nCoV diagnostic testing can take place at laboratories designated by CDC. These U.S. labs are qualified and certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity tests. These labs include 115 U.S. state and local public health laboratories and Department of Defense (DoD) laboratories. CDC 2019-nCoV RT-PCR Diagnostic Panel will not be available in U.S. hospitals or primary care settings.
The CDC 2019 novel coronavirus diagnostic test is intended for use with upper and lower respiratory specimens collected from people who meet CDC criteria for 2019-nCoV testing.
Clinical laboratories should NOT attempt viral isolation from specimens collected from 2019-nCoV patients 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.
Additional Resources
- CDC Information for Laboratories: 2019-nCoV
- International Reagent Resource (IRR) website
- CDC 2019 Novel Coronavirus website
- Register for CDC Health Alert Network (HAN) notifications, including updates about the 2019 Novel Coronavirus. Enter your email address, search for HAN, and sign-up.
If you have any questions, please contact us at LOCS@cdc.gov.
Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)