title: Evaluating Novel Diagnostics in an Outbreak Setting: Lessons Learned from Ebola.
abstract: Inadequate access to rapid testing for Ebola virus disease during the 2014-to-2016 outbreak led to an explosion in the development of diagnostics that could be performed at or near the point of care and by less-experienced operators, leading in turn to an acute need for novel test evaluation. Here, we present the challenges to development and evaluation of novel diagnostics in an emergency setting and suggestions for potential new "global emergency standards" to address them.
authors.affiliation: Department of Laboratory Medicine, Boston Children's Hospital. Harvard Medical School, Boston, Massachusetts, USA nira.pollock@childrens.harvard.edu.
authors.forename: Nira R
authors.initials: NR
authors.lastname: Pollock
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Betsy
authors.initials: B
authors.lastname: Wonderly
mesh_terms: D000354:Africa, Western / Q000453:epidemiology; D004196:Disease Outbreaks; D019142:Hemorrhagic Fever, Ebola / Q000175:diagnosis* / Q000453:epidemiology* / Q000821:virology; D006801:Humans; D019095:Point-of-Care Systems
keywords: Ebola; Ebola virus; diagnostic; diagnostics; outbreak; point of care