ArticleIJTLD open2025
Assessing the accuracy of the updated Fujifilm SILVAMP TB LAM II assay between lot numbers.
Article in IJTLD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- FujiLAM assays for tuberculosis detection in people with HIV: a systematic review and meta-analysis.BMC infectious diseases · 2025Pooled it
- 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
- Antigen heterogeneity in the development and clinical validation of a multiplexed urine test for tuberculosis.Communications medicine · 2026Article
- Rapid urinary lipoarabinomannan test with laboratory-level sensitivity for tuberculosis detection: a performance evaluation.Microbiology spectrum · 2026Article
- Diagnostic Performance of Second-Generation Fujifilm SILVAMP TB LAM in Nigerian Adults with Presumptive Tuberculosis.Journal of clinical medicine · 2025Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Fujifilm SILVAMP TB LAM (FujiLAM) assay, a point-of-care test detecting urine-based lipoarabinomannans, has demonstrated notable diagnostic accuracy for TB. However, FujiLAM exhibits lot-to-lot variability, limiting its clinical use. A new version of the product, Fujifilm SILVAMP TB LAM II (FujiLAM II), was developed to address this issue. This study evaluated the lot-to-lot variability and diagnostic accuracy of the FujiLAM II.
methodsWe assessed three lots of FujiLAM II using 158 biobanked, frozen urine specimens from people living with HIV (PLHIV): 72 TB-positive and 86 TB-negative, according to the microbiological reference standard.
resultsIndependent proportions of the results among the three FujiLAM II lots did not differ (Cochrane
conclusionThe FujiLAM II demonstrated no lot-to-lot variability and exhibited high sensitivity and specificity for TB diagnosis in patients with CD4 cell counts <200 cells/µL. The FujiLAM II enhanced reproducibility as a TB diagnostic tool in PLHIV.
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