ArticleThe Lancet. Global health2023
Novel FujiLAM assay to detect tuberculosis in HIV-positive ambulatory patients in four African countries: a diagnostic accuracy study.
Article in The Lancet. Global health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 5 of them syntheses that pooled it.
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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.
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Who cites it
42 citing papers in PubMed, 5 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- 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
- Diagnostic value of the cerebrospinal fluid lipoarabinomannan assay for tuberculous meningitis: a systematic review and meta-analysis.Frontiers in public health · 2023Pooled it
- Enhanced Tuberculosis Diagnosis With Computer-aided Chest X-ray and Urine Lipoarabinomannan in Adults With HIV Admitted to Hospital (CASTLE Study): A Cluster Randomized Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- 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
- Ultrasensitive urine LAM testing in HIV-negative tuberculosis: promising progress, but not yet a standalone diagnostic.Infection · 2026Article
- Current and Emerging Diagnostic Approaches for Tuberculosis in People Living with HIV: Challenges and Future Perspectives.Tropical medicine and infectious disease · 2026Review
- Novel human monoclonal antibodies with enhanced sensitivity for lipoarabinomannan antigens present in urines of TB patients.bioRxiv : the preprint server for biology · 2026Article
- Diagnostic accuracy of the Fujifilm SILVAMP TB LAM II (FujiLAM II) assay for the diagnosis of childhood tuberculosis.BMC infectious diseases · 2026Article
- An optimal processing method for recovery of tuberculosis in the tongue swab using theMicrobiology spectrum · 2026Article
- The use of urinary lateral-flow lipoarabinomannan assays for TB diagnosis in children.IJTLD open · 2026Article
- Salivary exosomalFrontiers 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
- 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
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Authors and funding
29 authors at 12 institutions in 7 countries.
Funding
Abstract
backgroundDevelopment of rapid biomarker-based tests that can diagnose tuberculosis using non-sputum samples is a priority for tuberculosis control. We aimed to compare the diagnostic accuracy of the novel Fujifilm SILVAMP TB LAM (FujiLAM) assay with the WHO-recommended Alere Determine TB-LAM Ag test (AlereLAM) using urine samples from HIV-positive patients.
methodsWe did a diagnostic accuracy study at five outpatient public health facilities in Uganda, Kenya, Mozambique, and South Africa. Eligible patients were ambulatory HIV-positive individuals (aged ≥15 years) with symptoms of tuberculosis irrespective of their CD4 T-cell count (group 1), and asymptomatic patients with advanced HIV disease (CD4 count <200 cells per μL, or HIV clinical stage 3 or 4; group 2). All participants underwent clinical examination, chest x-ray, and blood sampling, and were requested to provide a fresh urine sample, and two sputum samples. FujiLAM and AlereLAM urine assays, Xpert MTB/RIF Ultra assay on sputum or urine, sputum culture for Mycobacterium tuberculosis, and CD4 count were systematically carried out for all patients. Sensitivity and specificity of FujiLAM and AlereLAM were evaluated against microbiological and composite reference standards.
findingsBetween Aug 24, 2020 and Sept 21, 2021, 1575 patients (823 [52·3%] women) were included in the study: 1031 patients in group 1 and 544 patients in group 2. Tuberculosis was microbiologically confirmed in 96 (9·4%) of 1022 patients in group 1 and 18 (3·3%) of 542 patients in group 2. Using the microbiological reference standard, FujiLAM sensitivity was 60% (95% CI 51-69) and AlereLAM sensitivity was 40% (31-49; p<0·001). Among patients with CD4 counts of less than 200 cells per μL, FujiLAM sensitivity was 69% (57-79) and AlereLAM sensitivity was 52% (40-64; p=0·0218). Among patients with CD4 counts of 200 cells per μL or higher, FujiLAM sensitivity was 47% (34-61) and AlereLAM sensitivity was 24% (14-38; p=0·0116). Using the microbiological reference standard, FujiLAM specificity was 87% (95% CI 85-89) and AlereLAM specificity was 86% (95 CI 84-88; p=0·941). FujiLAM sensitivity varied by lot number from 48% (34-62) to 76% (57-89) and specificity from 77% (72-81) to 98% (93-99).
interpretationNext-generation, higher sensitivity urine-lipoarabinomannan assays are potentially promising tests that allow rapid tuberculosis diagnosis at the point of care for HIV-positive patients. However, the variability in accuracy between FujiLAM lot numbers needs to be addressed before clinical use.
fundingANRS and Médecins Sans Frontières.
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