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.
13. Cepheid. Package Insert 301-4732, Rev. D: Xpert Ebola Assay. April 2020. Accessed October 15, 2022. https://www.cepheid.com
