title: United States FDA's emergency use authorization of Ebola virus diagnostics: current impact and lessons for the future.
abstract: The Ebola outbreak that took hold in West Africa in 2014 outran the epidemic response capacity of many organizations. Five months after the epidemic was first declared, there were still only two laboratories in West Africa with the capacity to confirm Ebola virus infection. In the summer of 2014, before the first case of imported Ebola occurred in the USA, the US FDA announced it would issue Emergency Use Authorizations for Ebola virus in vitro diagnostics to speed their availability. Between October 2014 and March 2015, the FDA issued Emergency Use Authorizations for nine diagnostic products. The actions of the FDA not only allowed nationwide deployment of Ebola virus testing capacity in the USA but also established an attractive regulatory goalpost for companies developing assays for use in West Africa. Here, we comment on the diagnostic assays for which the FDA has issued emergency authorizations and their fitness for purpose.
authors.affiliation: a 1 Molecular and Translational Sciences Division, US Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Fort Detrick, MD, USA.
authors.forename: Chris A
authors.initials: CA
authors.lastname: Whitehouse
authors.affiliation: a 1 Molecular and Translational Sciences Division, US Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Fort Detrick, MD, USA.
authors.forename: Sina
authors.initials: S
authors.lastname: Bavari
authors.affiliation: b 2 Foundation for Innovative New Diagnostics, 9 Chemin des Mines, Geneva, Switzerland.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Perkins
mesh_terms: D000354:Africa, Western / Q000453:epidemiology; D057069:Diagnostic Test Approval; D004196:Disease Outbreaks; D019142:Hemorrhagic Fever, Ebola / Q000175:diagnosis* / Q000453:epidemiology; D006801:Humans; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
keywords: Ebola; assays; diagnostics; filoviruses; regulation; viral outbreaks