On February 4th, the FDA announced an Emergency Use Authorization for the CDC’s 2019 Novel Coronavirus real-time RT-PCR Diagnostic Panel. Here’s the press release:
Audience: Clinical Laboratory Professionals
Subject: Laboratory Update: Information about Emergency Use Authorization for 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel
Level: Laboratory Update
This message is to ensure that clinical laboratories are aware that 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. All EUA documents are available on the FDA website.
The test kit will be available for ordering today from the International Reagent Resource (IRR). Formerly, U.S. diagnostic testing for 2019-nCoV was only being conducted at CDC; however, 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.
The FDA website lists current EUA assays, and also includes a link to terminated EUA assays. Each pathogen-specific EUA includes the device-specific Letter of Authorization, fact sheets, and manufacturer instructions/package inserts. These documents are updated when amendments are made (e.g., additional specimen types, extraction methods, procedural clarifications), so check the website routinely to ensure your laboratory staff members have the most up-to-date information.
- 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 LOCS@cdc.gov.