Additional Testing Options for Consideration

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The page below is a sample from the LabCE course Ebola Virus Disease (EVD) and Clinical Laboratory Safety in the United States. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about Ebola Virus Disease (EVD) and Clinical Laboratory Safety in the United States (online CE course)
Additional Testing Options for Consideration

The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on October 25, 2014, for the FilmArray® Bio Threat-E10 (BioFire Diagnostics) - used for the presumptive identification of Ebola virus (Zaire). This provides laboratories, certified under CLIA to perform moderate to high complexity testing, with a rapid option (approximately one hour) to conduct a presumptive, in-house Ebola test for use with patients showing signs and symptoms of EVD.
On October 10, 2019, FDA allowed marketing in the US of the OraQuick Ebola Rapid Antigen Test11 (a rapid diagnostic test) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola.
Other rapid tests have become available and include the DPP Ebola Antigen System12 and Cepheid Xpert® Ebola Assay13, both EUA test methods.
All EVD suspect specimens must still be sent to the CDC or other Laboratory Response Network (LRN) facility. However, the implementation of in-house, rapid, presumptive Ebola testing can have a big impact on the facility's ability to provide additional diagnostic testing needed for the care of the patient. Each laboratory, working in a coordinated effort with its facility administrators and clinicians, should carefully consider and evaluate options that provide the best testing approach for its patients.

10. Biofire Defense. Information Sheet: Ebola Panels. August 2018. Accessed October 14, 2022. https://www.biofiredefense.com/wp-content/uploads/2018/08/Info-Sheet-Ebola-Panels-FLM1-PRT-0150.pdf
11. OraSure Technologies. Rapid Antigen Test: Ebola. Accessed October 14, 2022. https://www.orasure.com/products-infectious/OraQuick-Ebola.html
12. FDA. FDA authorizes emergency use of first Ebola fingerstick test with portable reader. November 2018. Accessed October 15, 2022. https://www.fda.gov/news-events/press-announcements/fda-authorizes-emergency-use-first-ebola-fingerstick-test-portable-reader
13. Cepheid. Package Insert 301-4732, Rev. D: Xpert Ebola Assay. April 2020. Accessed October 15, 2022. https://www.cepheid.com