Diagnosis of paediatric TB using Xpert® MTB/RIF Ultra on fresh respiratory samples
METHODS: Between July 2017 and December 2019, children with presumed TB were prospectively enrolled at clinical sites in three African countries. Children were assessed using history, physical examination and chest X-ray. Sputum or gastric aspirate samples were analysed using Ultra and culture. The diagnostic accuracy of Ultra was calculated against culture as the reference standard.
RESULTS: In total, 547children were included. The median age was 4.7 years, 77 (14.1%) were HIV infected and 77 (14.1%) had bacteriologically confirmed TB. Ultra detected an additional 20 cases in the group of children with negative culture results. The sensitivity of Ultra was 66.3% (95% CI 47–82), and the specificity was 95.4% (95% CI 89–99) when assessed against culture as the reference standard.
CONCLUSION: Despite the improved performance of Ultra as compared to Xpert as was previously reported, its sensitivity remains sub-optimal for the detection of TB in children. Ultra detected additional 20 cases which otherwise could not have been detected by culture alone, suggesting that the latter is an imperfect reference standard.
Keywords: RIF Ultra; Xpert MTB; childhood tuberculosis; diagnostics evaluation; pulmonary tuberculosis
Document Type: Research Article
Affiliations: 1: National Institute for Medical Research, Mbeya Medical Research Center, Mbeya, Tanzania, Center for International Health, University Hospital, Ludwig Maximilian University (LMU) Munich, Germany 2: National Institute for Medical Research, Mbeya Medical Research Center, Mbeya, Tanzania 3: Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia 4: Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia, Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK 5: Paediatrics Department, University Teaching Hospital Gabriel Toure, Bamako, Mali 6: University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali 7: Department of Paediatrics, Jos University Teaching Hospital, Jos, Nigeria 8: Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK 9: Center for International Health, University Hospital, Ludwig Maximilian University (LMU) Munich, Germany, German Centre for Infection Research (DZIF), Partner Site Munich, Munich, Germany, Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Germany
Publication date: September 1, 2022
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