The CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel detects the SARS-CoV-2 virus in upper and lower respiratory specimens.
It is designed to be used with an existing RT-PCR testing instrument commonly used to test for seasonal influenza. The U.S. Food and Drug Administration (FDA) gave Emergency Use Authorization (EUA) for this test on February 4, 2020.
The panel’s FDA-authorized Instructions for Useexternal icon contain information about the test, its intended use, test procedure, and performance characteristics.
The EUA websiteexternal icon has published the FDA Letter of Authorizationexternal icon for the diagnostic panel. The letter defines the authorized use and the conditions of