Abstract
BackgroundAn effective tuberculosis (TB) control programme requires early diagnosis and immediate initiation of treatment. Any delays in diagnosing TB not only impair a patient's prognosis, but also increase the risks of transmitting the disease within the community. Unfortunately, the most recent TB diagnostic tools still depend on high-infrastructure laboratories, making them poorly adapted for use in resource-limited settings. Additionally, existing tests show poor performance in diagnosing TB in children, people living with HIV/AIDS, and extrapulmonary forms of the disease. As a consequence, TB patients are still to date left with either fair access to poor diagnostics or poor access to fair diagnostics.DiscussionThis article discusses recent efforts to identify the minimal test specifications for a new TB point-of-care diagnostic test through an approach based on medical and patient needs. As a first step, survey interviews with field practitioners were designed in order to identify the top-priority medical needs in resource-limited settings concerning new TB diagnostics. Subsequently, an expert meeting convening field practitioners, laboratory experts, diagnostic test developers and researchers was held with the objective of defining the minimal test specifications for a new TB point-of-care test that would meet the identified medical needs. Finally, gaps in, as well as potential solutions for, enabling the development of adequate, patient needs-driven, low-cost new TB diagnostic tests specifically designed for vulnerable populations are discussed.SummaryAny new TB point-of-care diagnostic test should be designed to meet minimal specifications satisfying the most urgent medical needs in resource-poor settings. The major gaps for developing a new TB point-of-care test include identification of new biomarkers, simplification of technological platforms, development of adequate and accessible specimen banks, and identification and definition of reference standards for diagnosis of childhood TB. Innovative research and development funding ensuring de-linkage of research and development costs from the price of the new product, such as a prize fund mechanism, could help focus these efforts towards the delivery of a much-needed point-of-care diagnostic test for TB.
Highlights
An effective tuberculosis (TB) control programme requires early diagnosis and immediate initiation of treatment
The ideal characteristics for the design of a diagnostic test for resource-limited settings have been suggested as Affordable, Sensitive, Specific, User-friendly, Rapid, Equipment-free, and Delivered to those in need [3], all existing methods and those under development do not fulfil many of these criteria
The meeting group was composed of 34 participants with recognized expertise in a wide range of relevant areas, including clinicians and laboratory experts with significant field experience in resource-limited settings, representatives from patient community groups, test developers, and research scientists working in the area of TB diagnostics
Summary
Expert survey: keeping an ear to the ground With the objective of identifying, discussing and answering key medical questions about the development of a new test for TB, Médecins Sans Frontières, the Treatment. The meeting group was composed of 34 participants with recognized expertise in a wide range of relevant areas, including clinicians and laboratory experts with significant field experience in resource-limited settings (additional to the survey respondents), representatives from patient community groups, test developers, and research scientists working in the area of TB diagnostics Such a multidisciplinary group was brought together with the aim of enabling a fruitful, cross-disciplinary dialogue between end users and test developers and to ensure the translation of medical needs into test specifications that would be feasible on the basis of the technological and scientific advances. Summary While the survey opinions of practitioners in resourcelimited settings reflected patient medical needs, experts from a multidisciplinary group agreed that any new TB POC test should minimally achieve specifications that meet those medical needs To reach this ultimate objective, efforts should be made to address the four major gaps identified, namely, the identification of new biomarkers, development of new POC technological platforms, establishment of adequate specimen banks, and increased funding dedicated to TB diagnostics R&D.
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