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

i

Up-to-date Information

Up-to-Date Info: To find the latest CDC information on this topic go to: http://www.cdc.gov/zika/index.html

Fact sheet for health care providers : interpreting Zika MAC-ELISA results

Filetype[PDF-203.96 KB]


  • English
    • Details You May Also Like

    Details:

    • Corporate Authors:
      Centers for Disease Control and Prevention (U.S.)
    • Description:
      Centers for Disease Control and Prevention Zika MAC-ELISA Emergency Use Authorization

      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) Zika IgM antibody capture ELISA (Zika MAC-ELISA) for the in vitro qualitative detection of human IgM antibodies to Zika virus. It is intended for use in sera or cerebrospinal fluid (CSF) when submitted with a patient-matched serum sample from individuals meeting CDC Zika clinical and epidemiological criteria for testing in qualified laboratories designated by the CDC. The test is intended for use as part of CDC’s algorithm for Zika testing.

      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 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 Zika MAC-ELISA. For more information on this EUA, please see FDA’s website at http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm.

      zika-mac-elisa-fact-sheet-for-hcp.pdf

    • Subjects:
    • Document Type:
      Pamphlet (or booklet)
    • 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