Journal
JOURNAL OF INFECTIOUS DISEASES
Volume 211, Issue -, Pages S29-S38Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jiu821
Keywords
tuberculosis; diagnosis; target product profiles; prioritization; point-of-care
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Funding
- Bill and Melinda Gates Foundation [OPP1061487, OPP1018924]
- Burroughs -Wellcome Fund from the American Society of Tropical Medicine and Hygiene
- federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services [HHSN272200800014C]
- Bill and Melinda Gates Foundation [OPP1018924] Funding Source: Bill and Melinda Gates Foundation
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To accelerate the fight against tuberculosis, major diagnostic challenges need to be addressed urgently. Post-2015 targets are unlikely to be met without the use of novel diagnostics that are more accurate and can be used closer to where patients first seek care in affordable diagnostic algorithms. This article describes the efforts by the stakeholder community that led to the identification of the high-priority diagnostic needs in tuberculosis. Subsequently target product profiles for the high-priority diagnostic needs were developed and reviewed in a World Health Organization (WHO)-led consensus meeting. The high-priority diagnostic needs included (1) a sputum-based replacement test for smear-microscopy; (2) a non-sputum-based biomarker test for all forms of tuberculosis, ideally suitable for use at levels below microscopy centers; (3) a simple, low cost triage test for use by first-contact care providers as a rule-out test, ideally suitable for use by community health workers; and (4) a rapid drug susceptibility test for use at the microscopy center level. The developed target product profiles, along with complimentary work presented in this supplement, will help to facilitate the interaction between the tuberculosis community and the diagnostics industry with the goal to lead the way toward the post-2015 global tuberculosis targets.
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