Advanced Search
Select up to three search categories and corresponding keywords using the fields to the right. Refer to the Help section for more detailed instructions.

Search our Collections & Repository

All these words:

For very narrow results

This exact word or phrase:

When looking for a specific result

Any of these words:

Best used for discovery & interchangable words

None of these words:

Recommended to be used in conjunction with other fields

Language:

Dates

Publication Date Range:

to

Document Data

Title:

Document Type:

Library

Collection:

Series:

People

Author:

Help
Clear All

Query Builder

Query box

Help
Clear All

For additional assistance using the Custom Query please check out our Help Page

i

Fact sheet for health care providers : Interpreting CDC Ebola virus NP Real-Time RT-PCR (EBOV NP rRT-PCR) Assay results

Filetype[PDF-717.88 KB]


  • English
    • Details You May Also Like

    Details:

    • Corporate Authors:
      Centers for Disease Control and Prevention (U.S.)
    • 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

    • Subjects:
    • Document Type:
      Pamphlet (or booklet)
    • Genre:
      Fact Sheet
    • Collection(s):
    • Main Document Checksum:
    • Download URL:
    • File Type:

    Supporting Files

    • No Additional Files

    More +

    You May Also Like

    Checkout today's featured content at stacks.cdc.gov