Observational studyThe Lancet. Microbe2025
Performance of stool Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis among adults living with HIV: a multicentre, prospective diagnostic study.
Observational study in The Lancet. Microbe, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05047315 (Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV), which is not on this map. Cited by 10 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV
Who cites it
10 citing papers in PubMed.
- Expanding Xpert MTB/RIF Ultra and lateral flow urine lipoarabinomannan testing for diagnosis of tuberculosis among adults living with HIV admitted to hospitals in Tanzania and Mozambique (EXULTANT): a randomised controlled trial.The Lancet. Infectious diseases · 2026Trial
- Diagnostic performance of a centrifugation-free stool processing kit in conjunction with XpertBMC infectious diseases · 2026Trial
- Integrative profiling of oral fungal communities acrossAnnals of medicine · 2026Article
- Blood kynurenine pathway metabolites show limited diagnostic utility for tuberculosis among adults living with human immunodeficiency virus and children in Uganda.IJID regions · 2026Article
- Closing gaps through innovation in the tuberculosis pathology value chain.Journal of clinical tuberculosis and other mycobacterial diseases · 2026Review
- Towards tuberculosis elimination in people with HIV on antiretroviral therapy: evidence from a two-decade nationwide cohort in Spain.Infectious diseases of poverty · 2026Article
- A Year in Review on Tuberculosis and Non-tuberculous Mycobacteria Disease: A 2026 Update for Clinicians and Scientists.Pathogens & immunity · 2026Review
- Evaluation of the Performance of Stool Samples to Diagnose Pediatric Pulmonary Tuberculosis in Routine Care: A Cohort Study From Pakistan.Open forum infectious diseases · 2025Article
- Utility of alternative specimens in the diagnosis of pulmonary tuberculosis in people living with human immunodeficiency virus in Guinea.BMC infectious diseases · 2025Article
- Global burden of tuberculosis attributable to diet low in whole grains from 1990 to 2021, with projection to 2045.Frontiers in nutrition · 2025Article
Corrections and comments
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Authors and funding
21 authors.
Funding
Abstract
backgroundWhen people living with HIV develop pulmonary tuberculosis, it often manifests without detectable acid-fast bacilli on sputum microscopy. We aimed to assess the diagnostic accuracy of stool Xpert MTB/RIF Ultra (hereafter, Ultra) for Mycobacterium tuberculosis detection among adults with HIV.
methodsThis multicentre, prospective diagnostic accuracy study was done in outpatient and inpatient health centres in Eswatini, Mozambique, and Uganda. We enrolled adults aged 15 years and older with HIV with presumptive tuberculosis. We evaluated the diagnostic accuracy of stool Ultra using the simple one-step processing method against a composite microbiological reference standard (CMRS) including three WHO-recommended tuberculosis diagnostic tests (urine tuberculosis biomarker-based lateral-flow lipoarabinomannan [TB-LAM], sputum Ultra, and sputum culture), and stratified by CD4 cell count. We compared sputum versus stool Ultra performance against a composite reference standard of TB-LAM and sputum culture (CMRS2). We also calculated the diagnostic yield among all tested. This study is registered with ClinicalTrials.gov, NCT05047315.
findingsBetween Dec 2, 2021, and Aug 14, 2024, 677 participants were enrolled (247 [36%] men and 430 [64%] women). Tuberculosis was microbiologically confirmed in 119 participants by the CMRS: 39 (33%) had a positive test with sputum Ultra, 30 (25%) had a positive test with culture, and 84 (71%) had a positive test with urine TB-LAM. The sensitivity of stool Ultra compared with CMRS was 23·7% (28/118 [95% CI 16·4-32·4]) and the specificity was 94·0% (504/536 [91·7-95·9]). The sensitivity of stool Ultra in participants with CD4 counts less than or equal to 200 cells per μL was 45·5% (10/22 [24·4-67·8]) compared with 21·3% (17/80 [12·9-31·8]) in those with CD4 counts greater than 200 cells per μL. Against the CMRS2, we observed no differences in sensitivity between sputum and stool Ultra on the basis of CD4 cell count. Stool Ultra resulted in additional cases detected of 23% (30/133) compared with sputum Ultra, 29% (38/133) compared with sputum culture, and 33% (44/133) compared with TB-LAM. The overall diagnostic yield for all treated for stool Ultra was 9% (60/677), for TB-LAM was 12% (84/677), for sputum Ultra was 6% (39/677), and for sputum culture was 4% (30/677).
interpretationThese results suggest stool Ultra could be used as an additional test for tuberculosis diagnosis among people with HIV, particularly among those with CD4 counts less than 200 cells per μL.
fundingEDCTP2 and EDCTP3 Programmes supported by the EU.
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