A collection of useful resources and guides for TB diagnostics. If you would like your resource listed here, please let us know!
Stage 0 - Identify Need
FIND engages and convenes stakeholders, including researchers, developers, disease specialists and end users, to prioritize unmet diagnostic needs and to identify, discuss and agree on the desired characteristics of priority tests, towards building consensus-based Target Product Profiles (TPPs) for diagnostic tools for TB and global health.
Annual Global TB Report
Updated annually, the main aim of this WHO report is to provide a comprehensive and up-to-date assessment of the TB epidemic, and of progress in prevention, diagnosis and treatment of the disease at global, regional and country levels.
Bm2Dx - Biomarkers to Diagnostics Database
FIND, in collaboration with McGill & New Diagnostics Working Group, has developed Bm2Dx, a web platform mapping the status of biomarker research. Bm2Dx allows stakeholders to visualize the R&D landscape and access comprehensive information on biomarker candidates. Thanks to advanced search and analysis tools, IVD developers and donors can focus resources on candidates with potential to meet the target product profiles.
Diagnostics Pipeline Tracker
FIND has developed an interactive diagnostics pipeline, mapping the status and estimated release dates of diverse diagnostic solutions. This allows stakeholders to visualize the diagnostic landscape and track a product's potential availability for implementation. The status view maps each technology along the stages of development for diagnostic products. The timeline illustrates only the approximate date of commercial availability in low- and middle-income countries for each product, based on data that is publicly available. In the future, all of the diseases in FIND’s portfolio will be included in the interface.
High-priority target product profiles for tuberculosis diagnostics
TB diagnostics landscape 2017
Tuberculosis diagnostics technology landscape, May 2017, published by Unitaid
Stage 1 - Concept & feasibility
FIND Virtual Strain Bank
FIND hosts the Virtual Strain Bank (VSB), an online database that allows researchers and test developers to have an overview of globally accessible TB strains.
Based on input from more than 25 companies and test developers, this site presents the top 10 FAQs on TB diagnostics by test developers. Useful resources for each question have been posted.
Stage 2 - Development
BCCM/ITM Mycobacteria Collection
BCCM/ITM is hosted by and sharing its research interests with the Mycobacteriology Unit at the Institute of Tropcial Medicine in Antwerp, dedicated in research to combat tuberculosis, Buruli ulcer and other mycobacterial diseases.
FIND Specimen Bank
FIND manages several collections, including its own and two for WHO, of well-characterized TB specimens for use by researchers, developers and manufacturers of TB diagnostics. Providing access to these specimens serves to support the development and evaluation of new and existing tools to improve TB diagnosis. Sample types range from sputum to urine, plasma and serum.
Support for Success (S4S)
FIND's Support for Success (S4S) helps build sustainable know-how within a partnering company and offers comprehensive assistance and resources in a modular platform that covers areas such as R&D, product validation, regulatory and clinical affairs, quality systems and processes, customer support and distribution.
Stage 3 - Lab and clinical validation
FIND Clinical trial support platform
FIND maintains a well-established clinical trial platform to enable the collection of essential evidence for researchers, developers and implementers of new diagnostics. FIND’s team designs and conducts feasibility, development, evaluation and demonstration studies, in line with the demands of different stages on the clinical pathway to WHO review. FIND also leverages the platform to gather evidence for scale-up and policy refinement after products have received WHO approval and been adopted into global policy.
The Global Laboratory Initiative (GLI) is a network of international partners dedicated to accelerating and expanding access to quality assured laboratory services in response to the diagnostic challenges of TB, notably HIV-associated and drug-resistant TB. The GLI provides a focus for TB within the framework of a multi-faceted yet integrated approach to laboratory capacity strengthening.
Stage 4 - Regulatory approvals
FDA device advice
Device Advice is the US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) web page for regulatory education. It explains many aspects of medical device laws, regulations, guidances, and policies, covering both premarket and postmarket topics.
Stage 5 - WHO evaluation
Supporting WHO guidance
FIND conducts operational research to contribute to strengthened WHO guidance in laboratory quality management systems, clinical trial standards diagnostic connectivity standards, and multiple projects to enhance the landscape of TB testing.
TBevidence presents a comprehensive resource for evidence syntheses, policies, guidelines and research agendas on TB diagnostics.
WHO Policy - TB Diagnostics
WHO follows a systematic process for development of policy recommendations, involving synthesis of the available data through systematic reviews, assessment of the evidence by a Guideline Development Group using the GRADE approach, and development of policy guidance for dissemination to Member States and other stake holders.
Stage 6 - Country transition to scale
Implementing TB diagnostics: a policy framework
A WHO resource aimed at providing a generic framework or template for implementing TB diagnostics, encompassing the managerial, technical and operational processes required for developing and implementing a national strategy for TB laboratories to ensure the early diagnosis of TB and universal access to DST, as well as to ensure there is systematic screening of contacts of people with TB and high-risk groups.
Supranational Reference Lab Network
TB REACH is a multi-lateral funding mechanism primarily supported by Global Affairs Canada, with additional funding from the Bill and Melinda Gates Foundation. The Indonesia Health Fund has also made a pledge to support TB REACH’s Indonesian effort. TB REACH provides grants to partners for testing innovative approaches and technologies aimed at increasing the number of people diagnosed and treated for TB, decreasing the time to appropriate treatment and improving treatment success rates.
Stage 7 - Country adoption
The Global Drug Facility (GDF), an arm of the Stop TB Partnership, ensures access to high-quality TB dianostics and anti-TB drugs for countries in need, as a comprehensive procurement and logistics solution.
GHD Online - Global Health Diagnostics
An online community of over 1700 professionals, including diagnostic developers, clinicians, nurses, policy-makers, researchers, implementers, advocates and health educators, share questions, challenges, successes, and lessons learned to advance the field of global health diagnostics.