ArticleIJTLD open2026
The use of urinary lateral-flow lipoarabinomannan assays for TB diagnosis in children.
Article in IJTLD open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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24 authors.
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Abstract
backgroundDetection of lipoarabinomannan (LAM) in urine is a promising non-sputum-based test for TB. We aimed to evaluate Fujifilm SILVAMP TB-LAM (FujiLAM) for the diagnosis of TB in children, using AlereLAM as a comparator.
methodsBetween January 2019 to July 2021, children and young adolescents with presumptive TB disease were enrolled in five countries as part of the RaPaed-TB study. Standardised microbiological, radiologic, and clinical data were used to define TB category following published consensus criteria. FujiLAM and AlereLAM were performed on a single urine sample at enrolment.
resultsOf 975 children enrolled, 818 (83.9%) had FujiLAM results available. Median age was 5.5 years (interquartile range 2.4-9.4), 83 (10.1%) had severe acute malnutrition, and 138 (16.9%) were living with HIV. Using a microbiological reference standard, overall sensitivity of FujiLAM was 31.0% (95% confidence interval [CI]: 24.7-37.9) and that of AlereLAM 13.3% (95% CI: 9.0-18.8), whereas the overall specificity was 89.8% (95% CI: 86.3-92.7) and 92.7% (95% CI: 89.6-95.1), respectively. Marked differences in FujiLAM accuracy were noted between production lots.
conclusionFujiLAM remains a promising non-invasive, urine-based biomarker for childhood TB diagnosis. However, the observed lot-to-lot variability underscores the need for improved assays with rigorous multi-lot evaluations to ensure reliability in future studies.
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