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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.
Disclaimer
Opinions, interpretations, conclusions, and recommendations are those of the authors and are not necessarily endorsed by the US Army.
Financial & competing interests disclosure
M Perkins is an employee of the nonprofit Foundation for Innovative New Diagnostics. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.