Feasibility of stool-based GeneXpert for the diagnosis of pulmonary TB in children

BACKGROUND: The inability of children to readily provide a sputum sample for diagnosis of TB makes diagnosis challenging. Stool-based testing has been recommended by WHO since 2021, and this pilot assessed the feasibility of stool-based testing to diagnose childhood pulmonary TB in Malawi. METHODS: A mixed qualitative and quantitative cross-sectional prospective, clinic-based pilot in 8 hospitals. Key informant interviews and data capture forms in the open data kit software were used to collect qualitative and quantitative data. The Simple One Step (SOS) method was used for stool testing on GeneXpert Ultra platforms. RESULTS: A total of 536 children with presumptive TB were included in the final analysis. TB was detected in 31/ 536 (5.78%) stool samples. Healthcare workers found it easy to collect a stool sample and process it using the SOS method as a sample for Xpert and reported that guardians agreed to provide a stool sample for TB diagnosis for their child. CONCLUSION: Stool based testing is feasible and acceptable among health workers and can be integrated into routine services in Malawi. The SOS method is a viable option for stool processing for the diagnostic testing of TB in children using GeneXpert.