Guidance for using rapid diagnostic tests for Ebola in the United States
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Guidance for using rapid diagnostic tests for Ebola in the United States
  • Published Date:

    December 16, 2019

  • Series:
    HAN ; 423
  • Language:
Filetype[PDF-108.13 KB]

  • Description:
    Distributed via the CDC Health Alert Network December 16, 2019, 1400 EST (2:00 PM EST) CDCHAN-00423 In October 2019, the U.S. Food and Drug Administration (FDA) allowed marketing of the OraQuick® Ebola Rapid Antigen Test, a rapid diagnostic test (RDT) for detecting Ebola virus in both symptomatic patients and recently deceased people. This is the first Ebola RDT that FDA has allowed for marketing in the United States. The RDT should be used only in cases where more sensitive molecular testing is not available. All OraQuick® Ebola Rapid Antigen Test results are presumptive; all test results (positive and negative) must be verified through real-time reverse transcriptase polymerase chain reaction (rRT-PCR) testing at a Laboratory Response Network (LRN) laboratory located in 49 states and at the Centers for Disease Control and Prevention (CDC). Interpretation of RDT results should be done with caution and in consultation with relevant public health authorities to ensure appropriate testing and interpretation of results. RDT results should not be used to rule out Ebola infection or to determine the use or type of infection prevention and control precautions when managing a patient with Ebola compatible symptoms and epidemiologic risk factors. Healthcare providers with a patient with possible Ebola virus infection should first contact their local or state public health authorities before any testing is performed. CDC is available to provide consultation, technical assistance, and confirmatory testing as necessary.
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