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Evaluating a new stool based qPCR for diagnosis of tuberculosis in children and people living with HIV

Project description

Tuberculosis detection in HIV-affected settings of Africa

Despite a rising global tuberculosis (TB) burden, the number of people newly diagnosed with TB decreased by 18 % in 2020 during the COVID 19 pandemic. Thus, improving TB case detection, especially among children and people living with HIV (PLHIV), is necessary. In this context, the EU-funded STOOL4TB project aims to validate a new quantitative PCR assay for sensitive and specific detection of Mycobacterium tuberculosis, implemented in high TB and HIV burden settings of Eswatini, Mozambique, and Uganda, to improve TB lab-confirmation rates in children and PLHIV. The qPCR platform is more sensitive than Sputum Culture and Xpert Ultra. Additional funding is needed to achieve the target sample size and ensure the complete execution of all project objectives.

Objective

The COVID-19 pandemic had a devastating impact on tuberculosis (TB) control. In 2020, the number of people newly diagnosed with TB decreased by 18% despite a rising global TB burden. Intensified efforts to improve TB case detection are critically needed, especially in populations in whom bacteriological confirmation is suboptimal, such as children and people living with HIV (PLHIV) who have also been disproportionately affected by the pandemic. The need for highly sensitive sputum-free diagnostic tools for TB has never been greater.

STool4TB, an EDCTP-2 funded diagnostic trial, began its activities in 2020 shortly after the onset of the COVID-19 pandemic. The study aims to validate a novel quantitative PCR assay utilizing a stool homogenization and DNA isolation method that yields a highly sensitive and specific detection of Mycobacterium tuberculosis. STool4TB is implemented in high TB & HIV burden settings of Mozambique, Eswatini, and Uganda under the hypothesis that it will contribute to narrow the large TB case detection gap by improving TB lab-confirmation rates in children and PLHIV, while proving feasible and acceptable. New evidence suggests that this platform has a higher sensitivity when compared to sputum culture and Xpert Ultra and could have an additive lab-confirmation yield of up to 20%. STool4TB is also evaluating the qPCR platform as a treatment monitoring tool. This assay has the potential to be adapted to a POC diagnostic test which could be easily implemented in decentralized levels of care.

Given the impact of the COVID-19 pandemic on TB notifications at the three participating sites and on several STool4TB core activities, we request additional funding to finalize recruitment of participants and achieve the target sample size, ensuring full execution of all projects objectives. The observed upward trend in global TB burden makes the development of promising diagnostic tools, such as this novel stool-based qPCR, more important than ever.

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

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Call for proposal

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(opens in new window) HORIZON-JU-GH-EDCTP3-2023-01

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Coordinator

FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL BARCELONA
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.

€ 140 782,50
Address
C ROSSELLO 132 PLANTA 05
08036 Barcelona
Spain

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Region
Este Cataluña Barcelona
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Research Organisations
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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.

€ 140 782,50

Participants (5)

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