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How to get CDC’s COVID-19 diagnostic test and supplies

Filetype[PDF-120.84 KB]


  • English
    • Details Supporting Files Related Documents You May Also Like

    Details:

    • Corporate Authors:
      National Center for Immunization and Respiratory Diseases (U.S.). Division of Viral Diseases.
    • Description:
      Updated June 13, 2020

      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 Authorization 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.

      On June 12, 2020, FDA granted an amendment to the EUA for the CDC diagnostic test to address global shortages of materials needed to perform the test. This amendment provides alternatives for processing the test:

      • Four additional extraction reagents that can be used in the existing extraction methods

      • An additional extraction instrument and associated reagents

      • A new process that can be used in place of the extraction method when materials for the current method are limited

    • Content Notes:
      How to order the Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel -- Materials included in the diagnostic panel -- Other materials labs will need to perform the diagnostic panel.
    • Subjects:
    • Series:
      Coronavirus Disease 2020 (COVID-19)
    • Document Type:
      Webpage
    • Collection(s):
    • Main Document Checksum:
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