New diagnostics for TB in children
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According to the World Health Organization (WHO), tuberculosis is one of the ten most common causes of death in children under the age of five. One of the main reasons for this is that the disease is often not diagnosed correctly and in good time. This particularly affects regions with few resources. Available tests are too expensive, complex or technically complicated. There is an urgent need for new, child-friendly test procedures that can be carried out using simple samples (e.g. saliva). To change this, the "New TB Diagnostics" research group, led by Dr. med. Laura Olbrich, DPhil (LMU Clinical Scientist of the Year 2024), is evaluating new diagnostics. To this end, studies on new TB diagnostics are prepared, conducted and evaluated.
One focus is RaPaed-AIDA-TB (Rapid and Accurate Diagnosis of Paediatric TB - An AIDA (Assessment of Innovative Diagnostic and Algorithms for Early and Sensitive Detection of Acute TB)), one of the largest TB diagnostic studies in children. Results of the project were published in October 2023 in the journal The Lancet Infectious Diseases (see LMU news release, 31.10.2023).
The research group has also been contributing to the development of TB diagnostic recommendations by the World Health Organization (WHO).Further research on new tuberculosis diagnostics
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ManagementDr. med. Laura Olbrich, DPhilUnit Head New TB Diagnostics, Sponsor Medical ExpertTeamDr. Akshita Gupta, MD, PhDPostdoctoral Fellow DECIDE-TBFoczlbg-X;föbgvim/ful_vfiuyziu-SmiAlia Razid, MScPhD CandidateFälgeBgßnlmdvYimtful_vfiuyziusmiDoctoral/PhD candidatesDenise Banze, MDPhD Studentcand. med. Lisa Kübler
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Ongoing projects
Decide TB
The Decide-TB project is an implementation research project aiming to improve the diagnosis and management of tuberculosis in children by using treatment decision algorithms (TDAs).
These algorithms will help clinicians to make rapid and consistent decisions for the treatment of tuberculosis in children.
About the Decide TB project
Rapid and accurate diagnosis of paediatric tuberculosis (RaPaed TB)
RaPaed is one of the largest cohort and diagnostic studies ever conducted in the field of pediatric tuberculosis. It is funded by the European-African Cooperation European & Developing Countries Clinical Trials Partnership (EDCTP) and the German Center for Infection Research (DZIF).
At the heart of the project is a diagnostic validation study, which is being carried out together with local partners in five countries. Four sites are located in Africa (South Africa, Tanzania, Mozambique, Malawi) and one in India. The study will examine a total of 10 diagnostic approaches and evaluate eight new diagnostic tests. The performance of the tests will be compared with the reference standard for diagnostic validation studies for children.
The RaPaed-AIDA-TB project brings together experienced academic health centers and a center for clinical studies at LMU with academic test developers and large industrial partners. The tests are established through platforms that enable point-of-care testing or testing in local hospitals with shortened referral times. With the aim of strengthening healthcare structures and research worldwide, RaPaed-AIDA-TB also contributes to the local development of expertise in the diagnosis of childhood tuberculosis and the training of African researchers.
The study was completed in 2023.
News about the project
The RaPaed project consortium
Coordinator: LMU Klinikum München
Clinical study centers
- National Institute for Medical Research (NIMR - MMRC), Mbeya, Tanzania
- Instituto Nacional de Saúde (INS), Mozambique
- University of Malawi College of Medicine (CoM), Blantyre, Malawi
- University of Cape Town Lung Institute (UCTLI), Cape Town, South Africa
- Christian Medical College (CMC), Vellore, India
Consortium and project partners- LMU, Munich
- Foundation for Innovative New Diagnostics (FIND), Switzerland
- University of Melbourne, Australia
- Stellenbosch University, South Africa
- Karolinska Institute, Sweden
- Research Center Borstel, Germany
- NTP Tanzania, NTP, Mozambique
- MoH, Malawi
- OVG, Oxford University, UK
Industry partner
- Beckman Coulter, Inc.
- Cepheid
Financing
RaPaed-AIDA-TB is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP; RIA2016MC -1623) and the German Center for Infection Research (DZIF)
ADOPT RaPaed-TB
ADOPT RaPaed-TB: Three priorities for better diagnoses
The ADOPT RaPaed-TB project builds on the large RaPaed-TB study, completed in 2023, which investigated better ways to diagnose TB in children. The international study was coordinated in Munich and conducted in South Africa, Mozambique, Tanzania, Malawi, and India. A total of 975 children were included in the study. The study tested a blood test with a three-gene signature, urine and stool tests, and a novel immune cell marker.
The ADOPT RaPaed-TB now aims to use these valuable samples and data to develop improved diagnostics.
There are three focus areas:
New blood markers: The study is looking for patterns of gene activity and proteins that can indicate tuberculosis (transcriptomic and proteomic signatures).
Sputum-free tests: They are developing urine, stool, and blood tests that can directly detect TB bacteria.
Data combination: Combining all available data—clinical, laboratory, and biomarker results. Then, evaluate these data using modern methods, such as artificial intelligence, machine learning, and Bayesian models, to identify highly accurate diagnostic signatures.
By building on proven methods and using cutting-edge analysis, the goal is to create child-friendly TB tests that are fast, reliable, and suitable for use in different healthcare settings—helping more children receive the diagnosis and treatment they need.
Completed projects
Evaluation of improved screening algorithms in refugees using new diagnostics (Refuscreen TB) -
Decide-TB Consortium
- University of Bordeaux
- University of Zambia
- National TB Program Zambia
- Instituto nacional de Saúde (INS)
- National TB Program Mozambique
- Stellenbosch University
- LMU München (LMU)
- The University of Sheffield
- Institut de Recherche et Développement (IRD)
- Eduardo Mondlane University
- Imperial College of London
ADOPT RaPaed-TB Project Partners
- LMU Klinikum München
- Forschungszentrum Borstel, Leibniz Lungenzentrum
- Universitätsklinikum Heidelberg
- Fraunhofer-Institut für Translationale Medizin und Pharmakologie
The RaPaed project consortium
Overview RaPaed consortium partners and organization chart
Coordinator: LMU Klinikum MünchenClinical study centers
- National Institute for Medical Research (NIMR - MMRC), Mbeya, Tanzania
- Instituto Nacional de Saúde (INS), Mozambique
- University of Malawi College of Medicine (CoM), Blantyre, Malawi
- University of Cape Town Lung Institute (UCTLI), Cape Town, South Africa
- Christian Medical College (CMC), Vellore, India
Consortium and project partners- LMU, Munich
- Foundation for Innovative New Diagnostics (FIND), Switzerland
- University of Melbourne, Australia
- Stellenbosch University, South Africa
- Karolinska Institute, Sweden
- Research Center Borstel, Germany
- NTP Tanzania, NTP, Mozambique
- MoH, Malawi
- OVG, Oxford University, UK
Industry partner
- Beckman Coulter, Inc.
- Cepheid
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RaPaed-AIDA-TB
RaPaed-AIDA-TB is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP; RIA2016MC -1623) and the German Center for Infection Research (DZIF).
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Olbrich L, Verghese VP, Franckling-Smith Z, Sabi I, Ntinginya NE, Mfinanga A, Banze D, Viegas S, Khosa C, Semphere R, Nliwasa M, McHugh TD, Larsson L, Razid A, Song R, Corbett EL, Nabeta P, Trollip A, Graham SM, Hoelscher M, Geldmacher C, Zar HJ, Michael JS, Heinrich N; RaPaed-TB consortium.
Diagnostic accuracy of a three-gene Mycobacterium tuberculosis host response cartridge using fingerstick blood for childhood tuberculosis: a multicentre prospective study in low-income and middle-income countries.
Lancet Infect Dis. 2024 Feb;24(2):140-149.Olbrich L, Franckling-Smith Z, Larsson L, Sabi I, Ntinginya NE, Khosa C, Banze D, Nliwasa M, Corbett EL, Semphere R, Verghese VP, Michael JS, Ninan MM, Saathoff E, McHugh TD, Razid A, Graham SM, Song R, Nabeta P, Trollip A, Nicol MP, Hoelscher M, Geldmacher C, Heinrich N, Zar HJ; RaPaed-AIDA-TB consortium.
Sequential and parallel testing for microbiological confirmation of tuberculosis disease in children in five low-income and middle-income countries: a secondary analysis of the RaPaed-TB study.
Lancet Infect Dis. 2025 Feb;25(2):188-197.Olbrich L, Yang B, Poore H, Razid A, Sweetser B, Damkjær MW, Kay AW, Åhsberg J, Nathavitharana RR, Schiller I, Dendukuri N, Lundh A, Shah M, Bjerrum S, Jaganath D.
Parallel use of low‐complexity automated nucleic acid amplification tests on respiratory and stool samples with or without lateral flow lipoarabinomannan assays to detect pulmonary tuberculosis disease in children.
Cochrane Database Syst Rev 2025, Issue 6. Art. No.: CD016071. DOI: 10.1002/14651858.Bjerrum S, Yang B, Åhsberg J, Olbrich L, Damkjær MW, Nathavitharana RR, Broger T, Olaru ID, Sweetser B, Poore H, Razid A, Kay AW, Denkinger CM, Schiller I, Dendukuri N, Jaganath D, Lundh A, Shah M.
Parallel use of low‐complexity automated nucleic acid amplification tests and lateral flow urine lipoarabinomannan assays to detect tuberculosis disease in adults and adolescents living with HIV.
Cochrane Database Syst Rev 2025, Issue 6. Art. No.: CD016070. DOI: 10.1002/14651858