Guidance for clinical laboratories using FDA authorized diagnostic assays for Ebola virus detection
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Guidance for clinical laboratories using FDA authorized diagnostic assays for Ebola virus detection

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English
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    On October 25, 2014 the BioFire Defense “FilmArray Biothreat-E test” received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for the presumptive detection of Ebola Zaire virus in whole blood or undiluted urine specimens. Prior to this, the only diagnostic tests available in the U.S. were the Department of Defense (DoD) EZ1 Real-time RT-PCR Assay (FDA EUA August 5, 2014) performed in select State and Local Public Health Laboratory Response Network (LRN) Reference Laboratories, and CDC developed assays and confirmatory methods. Two CDC developed assays, CDC Ebola Virus NP and VP40 Real-time RT-PCR Assays, received EUA on October 10, 2014. Several other companies are in different stages of completing their applications for EUA of a number of additional commercially available Ebola Virus Disease (EVD) assays.

    Clinical laboratories considering implementation of commercially available EVD assays must remember the importance of connecting with Public Health authorities whenever EVD is suspected, the regulatory requirements for verification of assay performance before utilization for patient testing and to consider the risk/benefit of using this assay in their laboratory. This document is intended to provide laboratories with information to guide decisions on whether to implement any of the EVD in-vitro diagnostic assays available to clinical laboratories under EUA and includes a recommended algorithm for testing to support clinical and public health management of persons suspected to be infected with ebola virus. Clinical laboratories must consult with state or local Public Health partners both prior to testing and after testing to report results (both negative and positive) and determine next steps.

    This publication was supported by Cooperative Agreement # U60HM000803 funded by the Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC or the Department of Health and Human Services. National Center for Immunization and Respiratory Diseases (IP)Office of Surveillance, Epidemiology and Laboratory Services (OSELS)National Center for HIV, Viral Hepatitis, STDs and TB Prevention (PS)National Center for Zoonotic, Vector-borne, and Enteric Diseases (CK)National Center for Environmental Health (NCEH) Coordination Office for Terrorism Preparedness and Emergency Response (CTPER).

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