M. tuberculosis antigen detection by ICT in urine

Current sputum-based methods have limited TB diagnostic sensitivity. In addition, the incubation time, infrastructure, biosafety level, cost, and operational requirements of gold standard methods prevent their integration and use in primary care, where the patient first seeks care. Recently, assays based on urine LAM detection have provided an alternative for TB diagnosis in people with HIV.

With this project, we aim to evaluate the diagnostic performance of the new generation of urine LAM-based assays for TB diagnosis and to evaluate the ability to incorporate a processing step to improve the sensitivity of LAM-based assays.

Non-sputum-based LAM assays would allow diagnosing patients with difficulties in obtaining quality sputum samples (patients with extrapulmonary forms, HIV, or children). In addition, urine LAM assays' diagnostic and operational characteristics would facilitate same-day detection and initiation of TB treatment in primary care settings.

In this regard, we have evaluated the diagnostic capability of the Fujifilm SILVAMP TB-LAM prototype (FujiLAM, Fujifilm, Tokyo, Japan) in a Nigerian cohort of presumptive TB patients with and without HIV and in a Haitian cohort of children with presumptive TB. In addition, we are currently conducting a study in a European pediatric cohort to evaluate FujiLAM and the use of Ceres Nanotrap (Ceres Nanosciences, VA, EE. UU) particles to capture and concentrate LAM antigens in urine samples.

Leading partners: IGTP

Collaborating partners: PMU, SC, and SD Center 

External collaborating partners: University Hospital Mútua Terrassa (Spain); Saint-Damien Pediatric Hospital (Haiti); Zankli Research Centre and Department of Community Medicine (Nigeria); Liverpool School of Tropical Medicine (UK); Stop TB Partnership, TB REACH (Switzerland) 

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