FujiLAM assays for tuberculosis detection in people with HIV: a systematic review and meta-analysis.

backgroundThere is a global need for a rapid, accurate, and non-sputum point-of-care (PoC) assay for tuberculosis (TB), especially for people with HIV (PLHIV). The Fujifilm SILVAMP TB LAM (FujiLAM), a urine lipoarabinomannan assay, has shown promise for diagnosing TB in PLHIV. But diagnostic performances were inconsistent across studies. This systematic review and meta-analysis aimed to determine the pooled sensitivity and specificity of FujiLAM for TB diagnosis in PLHIV.

methodsA search was performed on August 10, 2025, across Scopus, PubMed, EMBASE, and Google Scholar using keywords including Fujifilm SILVAMP TB LAM, SILVAMP-LAM, FujiLAM, lipoarabinomannan test, Mycobacterium tuberculosis, tuberculosis, and TB. We included English-language studies that evaluated the FujiLAM test in PLHIV and contained data for a 2 × 2 table. Study quality was assessed with the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. A bivariate random effects model was applied to perform the meta-analysis using R and Stata 14.2. Subgroup analysis was conducted, and publication bias was investigated using Deeks' funnel plot and Egger's test.

resultsThirteen articles, encompassing 5,819 participants, were included. Individual study sensitivity varied from 34% to 78%, and specificity from 74% to 95%. The pooled sensitivity and specificity were 63% (95% CI: 55-71%) and 90% (95% CI: 86-92%), respectively, with an area under the curve (AUC) of 0.87 (95% CI: 0.85-0.91%), indicating good diagnostic accuracy. Subgroup analysis revealed higher pooled sensitivity in inpatients (71%, 95% CI: 51-84%) compared to outpatients (57%, 95% CI: 48-65%). Similarly, pooled sensitivity was elevated in patients with CD4 counts ≤ 100 cells/µL (76%, 95% CI: 61-87%) and ≤ 200 cells/µL (74%, 95% CI: 60-85%) compared to CD4 counts > 200 cells/µL (42%, 95% CI: 36-49%). Pooled sensitivity was comparable between participants enrolled based on TB symptoms (63%, 95% CI: 52-73%) and regardless of symptoms (63%, 95% CI: 50-75%). FujiLAM I sensitivity was 65% (95% CI: 58-72%), compared to 56% (95% CI: 33-76%) for FujiLAM II.

conclusionsFujiLAM demonstrated good diagnostic accuracy, with higher sensitivity for subgroups of patients with lower CD4 counts and inpatients. Although FujiLAM II appears less sensitive than FujiLAM I, it has high specificity and consistent accuracy across different production lots. Further research is warranted to enhance and validate FujiLAM's performance, especially in HIV-associated EPTB and children living with HIV. PROSPERO REGISTRATION: CRD42023461097.