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Description:Dear Health Care Provider:
The U.S Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to authorize the use of the Centers for Disease Control and Prevention’s (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 and cerebrospinal fluid (CSF). The assay also tests for Zika virus in urine and amniotic fluid specimens. Testing should only be conducted on specimens from individuals meeting CDC Zika clinical and epidemiological criteria for testing in laboratories designated by the CDC: http://www.cdc.gov/zika/hc-providers/index.html.
FDA issued this EUA based on data submitted by CDC to FDA, and on the U.S. Secretary of Health and Human Services’ (HHS) declaration that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Zika virus and/or diagnosis of Zika virus infection. This EUA will terminate when the HHS Secretary’s declaration terminates, unless FDA revokes it sooner.
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. For more information on this EUA, please see FDA’s website at (http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm).
fact-sheet-for-hcp-eua-trioplex-rt-pcr-zika.pdf
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