Trial reportPloS one2024
Prospective multicentre accuracy evaluation of the FUJIFILM SILVAMP TB LAM test for the diagnosis of tuberculosis in people living with HIV demonstrates lot-to-lot variability.
Trial report in PloS one, 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 26 papers, 4 of them syntheses that pooled it.
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
26 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- FujiLAM assays for tuberculosis detection in people with HIV: a systematic review and meta-analysis.BMC infectious diseases · 2025Pooled it
- Low-complexity automated nucleic acid amplification tests for extrapulmonary tuberculosis and rifampicin resistance in adults and adolescents.The Cochrane database of systematic reviews · 2025Pooled it
- Parallel use of low-complexity automated nucleic acid amplification tests and lateral flow urine lipoarabinomannan assays to detect tuberculosis disease in adults and adolescents living with HIV.The Cochrane database of systematic reviews · 2025Pooled it
- Parallel use of low-complexity automated nucleic acid amplification tests and lateral flow urine lipoarabinomannan assays to detect tuberculosis disease in adults and adolescents living with HIV.The Cochrane database of systematic reviews · 2024Pooled it
- Trial
- Current laboratory diagnostics for tuberculosis: from conventional approaches to next-generation molecular and immunological technologies.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026Review
- Diagnostic accuracy and inter-lot precision of the FujiLAM II point-of-care assay to detect tuberculosis in stored urine specimens from people living with HIV.Microbiology spectrum · 2026Article
- Current and Emerging Diagnostic Approaches for Tuberculosis in People Living with HIV: Challenges and Future Perspectives.Tropical medicine and infectious disease · 2026Review
- Diagnostic accuracy of the Fujifilm SILVAMP TB LAM II (FujiLAM II) assay for the diagnosis of childhood tuberculosis.BMC infectious diseases · 2026Article
- Prevalence and Mortality due toOpen forum infectious diseases · 2026Article
- The use of urinary lateral-flow lipoarabinomannan assays for TB diagnosis in children.IJTLD open · 2026Article
- Rapid urinary lipoarabinomannan test with laboratory-level sensitivity for tuberculosis detection: a performance evaluation.Microbiology spectrum · 2026Article
- Clinical evaluation of the diagnostic performances and treatment monitoring of the new PATHFAST TB LAM Ag assay in sputum specimens of patients with tuberculosis or with nontuberculous mycobacteria pulmonary disease.Journal of clinical microbiology · 2025Article
- Diagnostic Accuracy of the Updated FujiLAM II Assay to Detect Tuberculosis in Outpatients With Advanced HIV Disease.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Next-Generation Urinary LAM Assays-Are We There Yet?Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Article
- Article
- Diagnostic Performance of Second-Generation Fujifilm SILVAMP TB LAM in Nigerian Adults with Presumptive Tuberculosis.Journal of clinical medicine · 2025Article
- PERFORMANCE OF FUJILAM VERSION 1 FOR THE DIAGNOSIS OF TUBERCULOSIS IN CHILDREN UNDER 5 YEARS IN UGANDA - A BRIEF REPORT.medRxiv : the preprint server for health sciences · 2025Article
- A Prospective Evaluation of the Diagnostic Accuracy of the Point-of-Care VISITECT CD4 Advanced Disease Test in 7 Countries.The Journal of infectious diseases · 2025Article
- Assessing the accuracy of the updated Fujifilm SILVAMP TB LAM II assay between lot numbers.IJTLD open · 2025Article
Corrections and comments
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Authors and funding
30 authors.
Funding
Abstract
There is an urgent need for rapid, non-sputum point-of-care diagnostics to detect tuberculosis. This prospective trial in seven high tuberculosis burden countries evaluated the diagnostic accuracy of the point-of-care urine-based lipoarabinomannan assay FUJIFILM SILVAMP TB LAM (FujiLAM) among inpatients and outpatients living with HIV. Diagnostic performance of FujiLAM was assessed against a mycobacterial reference standard (sputum culture, blood culture, and Xpert Ultra from urine and sputum at enrollment, and additional sputum culture ≤7 days from enrollment), an extended mycobacterial reference standard (eMRS), and a composite reference standard including clinical evaluation. Of 1637 participants considered for the analysis, 296 (18%) were tuberculosis positive by eMRS. Median age was 40 years, median CD4 cell count was 369 cells/ul, and 52% were female. Overall FujiLAM sensitivity was 54·4% (95% CI: 48·7-60·0), overall specificity was 85·2% (83·2-87·0) against eMRS. Sensitivity and specificity estimates varied between sites, ranging from 26·5% (95% CI: 17·4%-38·0%) to 73·2% (60·4%-83·0%), and 75·0 (65·0%-82·9%) to 96·5 (92·1%-98·5%), respectively. Post-hoc exploratory analysis identified significant variability in the performance of the six FujiLAM lots used in this study. Lot variability limited interpretation of FujiLAM test performance. Although results with the current version of FujiLAM are too variable for clinical decision-making, the lipoarabinomannan biomarker still holds promise for tuberculosis diagnostics. The trial is registered at clinicaltrials.gov (NCT04089423).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.