Target product profile on IVD assays for the detection of Yellow Fever in the context of surveillance

Call for public consultation

3 February 2025
Call for submissions

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. The inclusion of newly approved YF assays is needed to ensure the availability of testing methods. 

The proposed Target Product Profile (TPP) 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 standardized IgM immunoassay test kit
  • Rapid IgM immunoassay test
  • Rapid antigen test

The World Health Organization is now seeking feedback on this draft Target Product Profile from industry, product developers, the scientific community, implementers, clinicians, and anyone involved in the management and control of Yellow Fever.                                                            

Comments may be submitted by individuals or organizations, on any of the above four tests, or for all four.

Please submit your comments by the 4th March 2025 by completing and returning the following Excel Feedback Form to gyflan@who.int

Proposed revisions arising from this public consultation will be considered by the TPP Development Group before the TPP is finalized.