Evaluation of New Diagnostics for Incident, Active and Recurrent TB
ENDxTB is an international research project funded by The National Institutes of Health (NIH). Our goal is to pave the way for cost-effective, novel, and improved diagnostic strategies for tuberculosis (TB).
ENDxTB is running between June 2020 and January 2026.
The ENDxTB consortium will conduct a clinical project across the globe to compare side-by-side the most promising new biomarker tests for a range of health care settings. We have included experienced clinical sites in Africa (South Africa, The Gambia) and Southeast Asia (Vietnam), and advanced laboratories in the USA and Europe, to test the performance of novel assays. Our cohorts include adults, children, and people living with HIV infection. The project is open to the inclusion of new assays from external collaborators. If you would like to include your innovative TB assay in the ENDxTB project, please contact us.
Core activities overview
Clinical Studies
Lead: Gerhard Walzl (SUN)
ENDxTB will conduct a multi-site, longitudinal, clinical project to compare head-to-head the most promising new tests for tuberculosis for different levels of health care settings. Experienced clinical sites in Africa (South Africa: SUN, UCT; The Gambia: MRCG) and South East Asia (Vietnam: OUCRU) will test children, adolescents, and adults who present to primary health care settings with symptoms suggestive of TB and will analyse novel tests alongside standard microbiological evaluation to ensure an unbiased evaluation. Additionally, confirmed TB cases will be followed up and their close contacts assessed to determine the utility of the same tests for treatment monitoring and prognosis for incident TB respectively. The SUN team will provide oversight and internal monitoring of ENDxTB clinical activities at each of the field sites. Protocols, case definitions and all clinical procedures will be harmonized across all study sites to allow pooling of data and to ensure statistical power to address the research questions. Study cohorts will include children and adults as susceptibility, clinical presentation and diagnostic features differ between age groups. We will also include people living with HIV infection, due to its major impact on the TB epidemic.
Test Evaluation
Lead: Jayne Sutherland (MCRG)
A pipeline of novel tests that are suitable for different levels of health care and that target several key phases of host-pathogen interaction will be assessed and evaluated. These novel assays include point of care triage and diagnostic tests as well as predictive biomarker tests and will be compared to a selected panel of gold standard tests which together represent the composite diagnostics currently in use.
Data Management & Analysis
Leads: Gian van der Spuy and Gerard Tromp (SUN)
Activities will include coordination of database aspects, statistical aspects and informatics. Specifically, a project-specific online database will be set up ib the initial phase of the project to take up data generated in the clinical studies. An online dashboard will allow to monitor essential metrics such as enrollment rates, prevalence of TB cases, data completeness (demographic, clinical and test results), follow-up visit compliance etc., presenting the current status on overall project level as well as per site. Data will be analyzed to assess test performance, with the aim to identify tests that meet or exceed TPPs, and to perform head-to-head comparisons of the tests to identify which test in any given category is superior to others.
Project Management & Dissemination
Lead: Britta Theobald (LINQ)
Project management activities will ensure a smooth and timely implementation of project and include the coordination of internal communication, contract management, organisation and documentation of meetings, as well as project reporting. We will also enable the inclusion of new sites and new tests and support the interaction of ENDxTB with local TB control programs and ministries of health.
To boost visibility of ENDxTB and enhance outreach LINQ will guide external communication and support dissemination activities throughout the project lifetime.
Team
ENDxTB brings together expertise and existing infrastructure to allow for the clinical testing of field-ready diagnostic tests and platforms for TB, and to provide a mechanism by which emerging tests and platforms can be evaluated as they become field-ready. To accomplish this goal the consortium combines the expertise of bacteriologists, immunologists, platform and test developers, and clinicians from four different continents.
The three project PIs Gerhard Walzl (SUN), Jayne Sutherland (MRCG) and John Belisle (CSU) will jointly direct the initiative, fostering synergy and integration of all project activities.
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