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Fact sheet for healthcare providers : Interpreting Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) results
  • Published Date:
    September 21, 2016
  • Language:
    English
Filetype[PDF - 61.12 KB]


Details:
  • Corporate Authors:
    Centers for Disease Control and Prevention (U.S.)
  • Description:
    The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use of the Centers for Disease Control and Prevention (CDC) Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) for the in vitro qualitative detection of Zika virus with specified instruments. This assay tests for Zika virus, dengue virus and chikungunya virus RNA in serum, as well as whole blood and cerebrospinal fluid (CSF) (each collected alongside a patient-matched serum specimen). The assay also tests for Zika virus in urine, and amniotic fluid specimens (each collected alongside a patient-matched serum specimen). Testing should be conducted on specimens from people who meet CDC Zika clinical and/or epidemiologic criteria for testing and be performed in laboratories designated by the CDC; see www.cdc.gov/zika/hc-providers/index.html. This test is should be performed according to CDC’s algorithm for Zika testing (see http://www.cdc.gov/zika/laboratories/lab-guidance.html).

    The information in this Fact Sheet is to inform you of the significant known and potential risks and benefits of the emergency use of the Trioplex rRT-PCR (see www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm).

    fact-sheet-for-hcp-eua-trioplex-rt-pcr-zika.pdf

  • Supporting Files:
    No Additional Files