Product Landscape of Rapid Diagnostic Tests for Viral Hemorrhagic Fever Pathogens

The recent Ebola - Zaire outbreak highlighted the need to understand the current and potential availability of diagnostic assays for a number of viral hemorrhagic fevers. The potential product landscape for rapid diagnostics of viral hemorrhagic fevers is extensive. The vast majority of these assays were developed in academic or government laboratories and have not progressed further toward commercialization or broad public health use. Subsequently, their approval under an Emergency Use Authorization may be delayed due to the lack of validation and standardization required for deployment as a reliable diagnostic tool. Lastly, the validation methods by which each assay was tested varied greatly, resulting in difficultly drawing direct comparisons amongst assays.