Target product profile on in vitro diagnostic assays for the detection of yellow fever in the context of surveillance
Overview
Yellow fever (YF) is an arboviral disease transmitted predominantly by mosquitoes of the Aedes and Haemagogus genera. From 2016 to 2018, the largest YF outbreaks in decades were reported in Africa and South America. Since December 2015, thousands of YF cases and several hundreds of related deaths were reported in Angola, Democratic Republic of Congo, Uganda, Nigeria, Brazil, Bolivia, Ecuador, Columbia, French Guiana, Peru and Suriname. Some imported cases of YF have also been reported in China and Europe.
Gaps and challenges in the rapid identification of YF outbreaks must be addressed to support effective vaccine campaigns and reduce the spread of the disease. Data and geographical distribution are representative of YF activity and are indispensable for adequate and efficient planning for vaccination campaigns.
Researchers, developers, and manufacturers use published Target Product Profiles (TPPs) to ensure that R&D activities are focused on relevant products and designed for the contexts and needs of end-users. The inclusion of newly approved YF assays is needed to ensure the availability of testing methods.
The Target Product Profile (TPP) document highlights the minimal and optimal characteristics required to guide forthcoming efforts in YF assay development and address end user needs.
This TPP comprises four types of tests to identify Yellow Fever infections in the context of surveillance:
- a standardized molecular assay test kit
- a standardised IgM immunoassay test kit
- a rapid IgM immunoassay test
- a rapid antigen test
