The Biomarkers for Fever Diagnostics (BFF-Dx) study will assess the performance of promising diagnostic tests that rely on biomarkers, and will compare these results with a target product profile (TPP) for tests that can differentiate bacterial and non-bacterial causes of fever in low-resource settings.
Why are we working on it?
The underlying diseases responsible for fever – which in low- and middle-income countries (LMICs) may include malaria, typhoid, pneumonia, and many benign and severe viral illnesses – can be major causes of morbidity and mortality, especially in children. Without a simple diagnostic to differentiate between bacterial and non-bacterial infections, healthcare professionals are left to rely on little more than clinical clues in the face of a negative malaria test. This leads to “just in case” antibiotic prescribing that exacerbates the global threat of antimicrobial resistance (AMR), even though recent data from Southeast Asia and a number of African countries have shown that viruses like dengue or chikungunya, rather than bacterial infections, are often the causative agents.
Biomarker-based diagnostics could help to address this challenge. In 2016, a consortium of global health and diagnostics experts including FIND developed a TPP for an assay that can distinguish bacterial from non-bacterial infections in low-resource settings, to provide actionable, evidence-based treatment guidance.
What does it involve?
The BFF-Dx study has been designed to evaluate potential candidate biomarkers against this TPP. Nearly 2,000 patients have been enrolled and the same protocol and analysis methodology are being employed at three sites in Malawi, Brazil and Gabon, to enable comparison between the different countries and settings.
What do we expect to achieve?
Biomarker assay performance data will inform critical diagnostic test development that is urgently needed to improve management of patients with non-malarial fever as well as help in the fight against AMR.
What is the timescale?
The BFF-Dx study is expected to complete in 2020.
Partners and funding
The project is being carried out together with our partners Malawi Epidemiology and Intervention Research Unit (MEIRU), Instituto Nacional de Infectologia Evandro Chagas (INI) and the Center of Medical Research Lambaréné (CERMEL).
For more information please contact us.
- Laboratory investigation of fever (factsheet)
- Electronic classification of fever (factsheet)
- Bacterial versus non-bacterial classification process (factsheet)
- Bacterial versus non-bacterial infections: a methodology to support use-case-driven product development of diagnostics (Escafadal et al.)
- BFF-Dx data from Malawi presented at ASTMH 2019 (Dittrich et al.)
- Biomarker research – an untapped avenue for tackling AMR? (BMJ Glob Health blog)