Defining use cases for biomarkers and tests across tuberculosis infection, disease and treatment: An international consensus and prioritisation exercise
- 1Imperial College London / North Bristol NHS Trust / University of Heidelberg
Abstract
BackgroundTranslation of tuberculosis (TB) biomarker and diagnostic research into tools that improve patient and public health outcomes has been slow, partly because no internationally agreed framework exists defining the use cases that new biomarkers and tests should address. We aimed to identify, validate, and prioritise use cases for TB biomarkers and tests across Mycobacterium tuberculosis (Mtb) infection, TB disease, TB treatment, and post-TB care, through an international consensus process.
Methods and FindingsWe conducted a scoping review of the literature, guidelines, and target product profiles (24 documents; 69 candidate use cases consolidated to 13), followed by a hybrid RAND/UCLA modified Delphi consensus process involving 185 identified interest-holders, including clinicians, researchers, diagnostic developers, industry, funders, civil society, national TB programmes, and policymakers (including WHO representatives). Interest-holders completed an online survey rating agreement with each use case, and attended a consensus meeting to discuss use cases with less than 80% agreement, followed by a further validation meeting. Eleven use cases were retained across four TB care pathway stages: three for Mtb infection, four for disease detection, three for treatment optimisation, and one for post-TB care. Highest-priority use cases were detection of drug-resistant TB, prediction of progression from infection to disease, identification of current Mtb infection, and improved diagnosis of active TB disease.
ConclusionsThis consensus exercise provides the first comprehensive, prioritised framework of use cases for TB biomarkers and tests, spanning the full care pathway. These eleven priority use cases can guide investment, focus biomarker discovery, and inform future target product profiles, funding calls, and policy development. Applying the framework to the current biomarker pipeline is a key next step to address gaps between innovation and priority needs.
Related
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- Prognostic utility of immune biomarkers for identifying individuals at risk of unfavourable treatment outcomes in pulmonary tuberculosis
- Latent tuberculosis infection in focus: Evaluating public concerns, treatment perceptions, and awareness in King Sabatha Dalindyebo Local Municipality, Eastern Cape, South Africa
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BibTeX
@misc{wright2026defining,
title = {{Defining use cases for biomarkers and tests across tuberculosis infection, disease and treatment: An international consensus and prioritisation exercise}},
author = {S. Wright and F. Fama and A. de Wilton and E. Steward and F. Saluzzo and C. Sepulcri and J. Greenan-Barrett and K. Mar Aung and T. M. Nguyen and N. Engel and S. Yerlikaya and H. Esmail and S. Charalambous and C. Miller and R. Nathavitharana and L. N. Q. Vo and M. Kohli and D. Goletti and D. Cirillo and M. Noursadeghi and C. M. Denkinger and E. L.-H. MacLean and R. K. Gupta and A. Gupta-Wright},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.01.26361598},
url = {https://www.medrxiv.org/content/10.64898/2026.09.01.26361598v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - Defining use cases for biomarkers and tests across tuberculosis infection, disease and treatment: An international consensus and prioritisation exercise
AU - S. Wright
AU - F. Fama
AU - A. de Wilton
AU - E. Steward
AU - F. Saluzzo
AU - C. Sepulcri
AU - J. Greenan-Barrett
AU - K. Mar Aung
AU - T. M. Nguyen
AU - N. Engel
AU - S. Yerlikaya
AU - H. Esmail
AU - S. Charalambous
AU - C. Miller
AU - R. Nathavitharana
AU - L. N. Q. Vo
AU - M. Kohli
AU - D. Goletti
AU - D. Cirillo
AU - M. Noursadeghi
AU - C. M. Denkinger
AU - E. L.-H. MacLean
AU - R. K. Gupta
AU - A. Gupta-Wright
PY - 2026
DA - 2026/09/01
PB - medRxiv
DO - 10.64898/2026.09.01.26361598
UR - https://www.medrxiv.org/content/10.64898/2026.09.01.26361598v1
AB - BackgroundTranslation of tuberculosis (TB) biomarker and diagnostic research into tools that improve patient and public health outcomes has been slow, partly because no internationally agreed framework exists defining the use cases that new biomarkers and tests should address. We aimed to identify, validate, and prioritise use cases for TB biomarkers and tests across Mycobacterium tuberculosis (Mtb) infection, TB disease, TB treatment, and post-TB care, through an international consensus process. Methods and FindingsWe conducted a scoping review of the literature, guidelines, and target product profiles (24 documents; 69 candidate use cases consolidated to 13), followed by a hybrid RAND/UCLA modified Delphi consensus process involving 185 identified interest-holders, including clinicians, researchers, diagnostic developers, industry, funders, civil society, national TB programmes, and policymakers (including WHO representatives). Interest-holders completed an online survey rating agreement with each use case, and attended a consensus meeting to discuss use cases with less than 80% agreement, followed by a further validation meeting. Eleven use cases were retained across four TB care pathway stages: three for Mtb infection, four for disease detection, three for treatment optimisation, and one for post-TB care. Highest-priority use cases were detection of drug-resistant TB, prediction of progression from infection to disease, identification of current Mtb infection, and improved diagnosis of active TB disease. ConclusionsThis consensus exercise provides the first comprehensive, prioritised framework of use cases for TB biomarkers and tests, spanning the full care pathway. These eleven priority use cases can guide investment, focus biomarker discovery, and inform future target product profiles, funding calls, and policy development. Applying the framework to the current biomarker pipeline is a key next step to address gaps between innovation and priority needs.
ER -