AI Article Synopsis
- The 2014 Ebola outbreak in West Africa exceeded the epidemic response capabilities of many organizations, with only two labs able to confirm infections five months in.
- The US FDA reacted by issuing Emergency Use Authorizations for Ebola diagnostic tests to facilitate rapid deployment of testing in the U.S.
- Between October 2014 and March 2015, the FDA approved nine diagnostic products, enhancing testing capacity in the U.S. and providing a regulatory benchmark for companies creating tests for West Africa.
Article 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.
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| http://dx.doi.org/10.1586/14737159.2015.1077117 | DOI Listing |
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