Diagnostic accuracy of urine AlereLAM and FujiLAM assays for diagnosing active tuberculosis in people living with HIV: a systematic review and meta-analysis
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Abstract
Background: People living with HIV (PLHIV) remain at high risk of active tuberculosis (TB), yet diagnosis is often challenging due to difficulty obtaining sputum and reduced sensitivity of conventional tests. Urine-based lipoarabinomannan (LAM) assays offer a rapid, non-sputum diagnostic approach. The more recent Fujifilm SILVAMP TB LAM (FujiLAM) may provide better diagnostic performance than the extensively used Alere Determine TB-LAM (AlereLAM).
Objectives: To evaluate the diagnostic accuracy of urine AlereLAM and FujiLAM for diagnosing active TB in PLHIV, and to compare the pooled diagnostic performance of AlereLAM versus FujiLAM.
Methods: We conducted a systematic review and a meta-analysis of diagnostic test accuracy in accordance with PRISMA-DTA guidelines. PubMed, Scopus, and SpringerLink were searched for studies published between 2016 and 2025. Eligible studies enrolled PLHIV evaluated for suspected active TB and assessed urine AlereLAM and/or FujiLAM against microbiological reference standards (MRS) and/or composite reference standards (CRS), with MRS prioritized. Diagnostic 2×2 data were extracted or reconstructed. Pooled sensitivity, specificity, likelihood ratios, and diagnostic odds ratios were estimated using a bivariate random-effects model, with separate analyses for AlereLAM and FujiLAM.
Results: Twenty-five diagnostic accuracy studies were included. AlereLAM demonstrated a pooled sensitivity of 0.364 (95% CI 0.272-0.467) and specificity of 0.928 (95% CI 0.875-0.960). In contrast, FujiLAM showed a substantially higher pooled sensitivity of 0.642 (95% CI 0.567-0.711) while maintaining a high specificity of 0.901 (95% CI 0.872-0.924). FujiLAM yielded a higher diagnostic odds ratio (16.34 vs 7.38), a higher positive likelihood ratio (6.49 vs 5.06), and a lower negative likelihood ratio (0.40 vs 0.69) than AlereLAM. Summary receiver operating characteristic (SROC) analyses demonstrated superior overall diagnostic accuracy for FujiLAM.
Conclusion: Urine FujiLAM showed markedly higher sensitivity than AlereLAM while maintaining high specificity for diagnosing active TB in PLHIV. These findings suggest that next-generation urine LAM assays may substantially improve TB case detection in this high-risk population, particularly in settings where sputum-based diagnostics are limited.
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