The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on October 25, 2014 for the FilmArray™ Biothreat-E (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.
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 their facility administrators and clinicians, should carefully consider and evaluate options that provide the best testing approach for their patients.