article · The International Journal of Tuberculosis and Lung Disease
Diagnosing tuberculosis in young children and critically ill adults is often difficult because they struggle to produce sputum. A routine implementation programme in Zambia validated and introduced stool-based testing using the Xpert MTB/RIF Ultra assay as an alternative approach. Method validation demonstrated 98.0 percent agreement between stool samples and standard sputum or gastric aspirate specimens. Following validation, the procedure was deployed in routine practice. Over an eighteen-month period, healthcare teams tested 16,210 stool samples. This testing identified 157 tuberculosis cases in children, including five cases with rifampicin resistance, as well as 45 cases in critically ill adults. Stool testing was used far more frequently than gastric aspiration in children aged under five. Following this implementation, childhood tuberculosis notifications rose by 30 percent and bacteriological confirmation rates rose by 53 percent between 2020 and 2021, providing timely diagnosis for patients unable to produce respiratory specimens.
Young children and very sick adults often cannot produce sputum for standard tuberculosis tests, while alternative methods like gastric aspiration are invasive and difficult to perform. Using stool samples offers a non-invasive, accessible diagnostic route that substantially improves detection and confirmation rates in vulnerable groups, ensuring quicker access to vital treatment.
This work represents an applied and clinically tested diagnostic implementation within routine healthcare delivery. The primary users are public health programmes, diagnostic laboratories, and hospital clinical staff managing tuberculosis in vulnerable populations. The operational validation of stool samples on existing Xpert MTB/RIF Ultra platforms demonstrates immediate real-world readiness, enabling health systems and diagnostics providers to expand testing service protocols without requiring new instrumentation.
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BACKGROUND We describe our approach and experience with the routine implementation of stool-based Xpert MTB/RIF Ultra (Xpert) testing for the diagnosis of childhood TB in Zambia. METHODS We conducted a method validation and subsequently introduced stool as an alternative sample for routine Xpert testing for children and critically ill adults. We reviewed the impact of stool-based Xpert testing during the first 18 months of routine implementation. RESULTS The method validation showed 98.0% (95% CI 92.9-99.4) agreement between Xpert results on sputum/gastric aspirate (GA) and stool specimens. During 18 months of routine implementation, 16,210 stool samples were tested, yielding 157 TB cases in children, including five rifampicin (RIF) resistant cases, and 45 cases in critically ill adults. In children aged 0-4 years, 10,288 stool samples were tested compared to 2,459 GA samples in the same period. Childhood TB notifications and the bacteriological confirmation rate increased by 30% and 53%, respectively, in 2021 compared to 2020. CONCLUSION The routine implementation of stool testing provided access to Xpert testing for children who could not produce sputum or have GA collected, contributing to increased bacteriological confirmation of TB in children. For critically ill adults with difficulty expectorating sputum, it facilitated a rapid test result. .
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DOI: 10.5588/ijtld.24.0349
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