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Up-to-date Information
Up-to-Date Info: To find the latest CDC information on this topic go to: https://www.cdc.gov/coronavirus/2019-nCoV/index.html
CDC’s diagnostic test for COVID-19 only and supplies
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Aug. 17, 2021
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Description:Updated Aug. 17, 2021
The CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time 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 virus.
The U.S. Food and Drug Administration (FDA) gave Emergency Use Authorization (EUA) for this test on February 4, 2020. The 2019-nCoV Real-Time RT-PCR Diagnostic Panel Instructions for Useexternal icon contain information about the test, its intended use, the 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 authorization that apply to CDC and to testing laboratories that use this test. Manufacturers and test developers interested in the right of reference to the 2019-nCoV Real-Time RT-PCR Diagnostic Panel performance data are encouraged to read these FAQs.
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Content Notes:How to order the 2019-CoV Real-Time RT-PCR Diagnostic Panel -- Materials included in the Diagnostic Panel -- Other materials labs will need to perform the Diagnostic Panel.
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