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Fact sheet for health care providers : Interpreting CDC Ebola virus NP Real-Time RT-PCR (EBOV NP rRT-PCR) Assay results
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March 2, 2015
[PDF-717.88 KB]
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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 (CDC) EBOV NP rRT-PCR Assay with specified instruments for the presumptive presence of Ebola virus (species Zaire ebolavirus) detected in whole blood, serum, plasma, and urine specimens.
This assay should be performed on specimens from individuals with signs and symptoms of Ebola in conjunction with epidemiological risk factors.
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 Ebola virus. This EUA will terminate when the HHS Secretary’s declaration terminates, unless FDA revokes it sooner.
Per CDC guidance, this test should be performed only on individuals with signs and symptoms of Ebola.
This Fact Sheet contains the minimum information necessary to inform you of the significant known and potential risks and benefits of the emergency use of the CDC EBOV NP rRT-PCR. For more information on this EUA, please see FDA’s website (http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm).
ebov-np-fact-hcp.pdf
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