Observational studyThe Lancet. Global health2024
Urine-Xpert Ultra for the diagnosis of tuberculosis in people living with HIV: a prospective, multicentre, diagnostic accuracy study.
Observational study in The Lancet. Global health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04089423 (Prospective Multicentre Evaluation of the Accuracy and Diagnostic Yield of the Fujifilm SILVAMP TB LAM), which is not on this map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Prospective Multicentre Evaluation of the Accuracy and Diagnostic Yield of the Fujifilm SILVAMP TB LAM (FujiLAM) Test for the Diagnosis of Tuberculosis in People Living With HIV
Who cites it
13 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
- Closing gaps through innovation in the tuberculosis pathology value chain.Journal of clinical tuberculosis and other mycobacterial diseases · 2026Review
- Prevalence and Mortality due toOpen forum infectious diseases · 2026Article
- Xpert Ultra on nasopharyngeal swabs detects one-third of pulmonary tuberculosis: a nested case-control study in South African primary care.Research square · 2026Article
- Efficacy of a chemiluminescence-based urinary LAM (AIMLAM) assay in the diagnosis of active TB in Chinese children.Microbiology spectrum · 2026Article
- Analysis of the diagnostic efficacy of targeted next-generation sequencing for tuberculosis in patients with HIV.Frontiers in cellular and infection microbiology · 2026Article
- A Systematic Review and Meta-analysis on Innovative Approaches in Tuberculosis Diagnosis: Challenges and Future Directions.International journal of MCH and AIDS · 2026Review
- Comparative Performance of Urine Lipoarabinomannan and Urine Xpert MTB/RIF Ultra for Diagnosing Tuberculosis in Adult Inpatients With HIV in East London, South Africa.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Utility of alternative specimens in the diagnosis of pulmonary tuberculosis in people living with human immunodeficiency virus in Guinea.BMC infectious diseases · 2025Article
- Tuberculosis and HIV coinfection: Progress and challenges towards reducing incidence and mortality.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2025Review
- Undiagnosed burden of latent tuberculosis, active tuberculosis and tuberculosis-HIV co-infections in Africa-status quo, needs, priorities, and opportunities.IJID regions · 2025Review
- Urine-based assays for inpatients with HIV-associated tuberculosis in rural South Africa.Southern African journal of HIV medicine · 2025Article
- A Year in Review on Tuberculosis and Non-tuberculous Mycobacteria Disease: A 2025 Update for Clinicians and Scientists.Pathogens & immunity · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors.
Funding
Abstract
backgroundDiagnostic delays for tuberculosis are common, with high resultant mortality. Urine-Xpert Ultra (Cepheid) could improve time to diagnosis of tuberculosis disease and rifampicin resistance. We previously reported on lot-to-lot variation of the Fujifilm SILVAMP TB LAM. In this prespecified secondary analysis of the same cohort, we aimed to determine the diagnostic yield and accuracy of Urine-Xpert Ultra for tuberculosis in people with HIV, compared with an extended microbiological reference standard (eMRS) and composite reference standard (CRS) and also compared with Determine TB LAM Ag (AlereLAM, Abbott).
methodsIn this prospective, multicentre, diagnostic accuracy study, we recruited consecutive inpatients and outpatients (aged ≥18 years) with HIV from 13 hospitals and clinics in seven countries (Malawi, South Africa, Tanzania, Thailand, Uganda, Viet Nam, and Zambia). Patients with no isoniazid preventive therapy in the past 6 months and fewer than three doses of tuberculosis treatment in the past 60 days were included. Reference and index testing was performed in real time. The primary outcome of this secondary analysis was the diagnostic yield and accuracy of Urine-Xpert Ultra compared with the eMRS and CRS. Diagnostic accuracy was compared with AlereLAM and diagnostic yield was compared with both AlereLAM and Sputum-Xpert Ultra. This study was registered with ClinicalTrials.gov, NCT04089423, and is complete.
findingsBetween Dec 13, 2019, and Aug 5, 2021, 3528 potentially eligible individuals were screened and 1731 were enrolled, of whom 1602 (92·5%) were classifiable by the eMRS (median age 40 years [IQR 33-48], 838 [52·3%] of 1602 were female, 764 [47·7%] were male, 937 [58·5%] were outpatients, 665 [41·5%] were inpatients, median CD4 count was 374 cells per μL [IQR 138-630], and 254 [15·9%] had microbiologically confirmed tuberculosis). Against eMRS as reference, sensitivities of Urine-Xpert Ultra and AlereLAM were 32·7% (95% CI 27·2-38·7) and 30·7% (25·4-36·6) and specificities were 98·0% (97·1-98·6) and 90·4% (88·7-91·8), respectively. Against CRS as reference, sensitivities of Urine-Xpert Ultra and AlereLAM were 21·1% (95% CI 17·6-25·1), and 30·5% (26·4-34·9), and specificities were 99·1% (98·3-99·6) and 95·1% (93·5-96·3), respectively. The combination of Sputum-Xpert Ultra with AlereLAM or Urine-Xpert Ultra diagnosed 202 (77·1%) and 204 (77·9%) of 262 eMRS-positive participants, respectively, in incompletely overlapping groups; combining all three tests diagnosed 214 (81·7%) of 262 eMRS-positive participants
interpretationUrine-Xpert Ultra could offer promising clinical utility in addition to AlereLAM and Sputum-Xpert Ultra. In inpatient settings where both AlereLAM and Urine-Xpert Ultra are possible, both should be offered to support rapid diagnosis and treatment.
fundingGlobal Health Innovative Technology Fund, KfW Development Bank, Commonwealth of Australia represented by the Department of Foreign Affairs and Trade, and the Netherlands Enterprise Agency.
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