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Prospective evaluation and refinement of novel biomarker-based point-of-care tests for the diagnosis of tuberculous meningitis in children

Objective

Childhood Tuberculous meningitis (TBM) is the most severe form of tuberculosis (TB), mostly affecting children. Diagnosis of TBM in children is challenging, necessitating up to six visits to hospitals. Furthermore, 50% of people who are diagnosed with TBM die or suffer life-long neurological problems. We previously identified, patented, and validated a 3-protein cerebrospinal fluid (CSF) biomarker signature, including IFN-γ, for the diagnosis of childhood TBM. We have developed a prototype point-of-care (PoC) lateral flow test based on this biosignature, in collaboration with LifeSADX, an industrial partner based in South Africa. We also developed a variant of the CSF-based test, based on the biosensor technology and have identified blood-based (BB) biomarkers which require refinement and subsequent development into a TBM PoC test. The potential alterations of IFN-γ detection or function due to autoantibodies or genetic mutations in these patients is currently unknown.
In this project, we aim to:
1) Gather evidence on the performances of the two newly developed CSF-based PoC tests at hospitals situated in South Africa, Zambia, and Zimbabwe
2) Refine our previously identified BB-biosignature in stored multi-country specimens, and incorporate the refined biomarkers into a new TBM prototype test, using biosensor technology
3) Prospectively evaluate the blood-based prototype test alongside the CSF-based tests
4) Test both immunologically and genetically, defects in IFN-γ immunity, a key biomarker on our CSF-based tests, in CSF and serum samples, and ascertain the relevance of such defects to possible disease development, and their influence on PoC test results
The project will bring together a multi-disciplinary team with different but complementary expertise including immunologists, human geneticists, neurologists, social scientists, and an industrial partner based in South Africa, and has potential to significantly influence the management of childhood TBM worldwide.

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HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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(opens in new window) HORIZON-JU-GH-EDCTP3-2025-04-two-stage

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Coordinator

STELLENBOSCH UNIVERSITY
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 429 020,00
Address
VICTORIA STREET ADMINISTRATION B BUILDING
7600 STELLENBOSCH
South Africa

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Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 429 020,00

Participants (5)

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