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Background <p>Point-of-care tests (POCTs) are urgently needed to improve tuberculosis (TB) diagnosis in children. This study evaluated the diagnostic accuracy of the Fujifilm SILVAMP TB LAM II (FujiLAM II) assay for childhood TB diagnosis.</p> Methods <p>Spot urine samples were collected from children with TB (either bacteriologically confirmed or clinically diagnosed) and from healthy controls, then tested using FujiLAM II. Sensitivity was assessed against microbiological and clinical reference standards, while specificity was determined against healthy controls.</p> Results <p>Of 137 participants, 87 had TB and 50 were controls. FujiLAM II showed overall sensitivity of 17.2%, higher in bacteriologically confirmed cases (36.8%) than in clinically diagnosed cases (11.8%). Sensitivity was better in children under five (27.9%), HIV-positive children (25.0%), and underweight or stunted children (24.0%). Specificity was 100%. In the subgroup of 66 children tested with both assays, detection rates did not differ significantly (28.8% vs. 22.7%). When results from either test were considered positive, the detection rate increased to 40.9%, representing a 12.1% improvement over Xpert Ultra alone.</p> Conclusion <p>FujiLAM II shows suboptimal sensitivity for childhood TB diagnosis, with better sensitivity in children under five years, HIV-positive, or malnourished, and may add value to current diagnostic algorithms.</p>

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Diagnostic accuracy of the Fujifilm SILVAMP TB LAM II (FujiLAM II) assay for the diagnosis of childhood tuberculosis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月8日

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  • Sosina Ayalew,
  • Teklu Wegayehu,
  • Sebsib Neway,
  • Tsion Seifu Adere,
  • Woinishet Tesfaye,
  • Awokech Berihun,
  • Biniam Wondale,
  • Anne Piantadosi,
  • Bamlak Tessema,
  • Adane Mihret

摘要

Background

Point-of-care tests (POCTs) are urgently needed to improve tuberculosis (TB) diagnosis in children. This study evaluated the diagnostic accuracy of the Fujifilm SILVAMP TB LAM II (FujiLAM II) assay for childhood TB diagnosis.

Methods

Spot urine samples were collected from children with TB (either bacteriologically confirmed or clinically diagnosed) and from healthy controls, then tested using FujiLAM II. Sensitivity was assessed against microbiological and clinical reference standards, while specificity was determined against healthy controls.

Results

Of 137 participants, 87 had TB and 50 were controls. FujiLAM II showed overall sensitivity of 17.2%, higher in bacteriologically confirmed cases (36.8%) than in clinically diagnosed cases (11.8%). Sensitivity was better in children under five (27.9%), HIV-positive children (25.0%), and underweight or stunted children (24.0%). Specificity was 100%. In the subgroup of 66 children tested with both assays, detection rates did not differ significantly (28.8% vs. 22.7%). When results from either test were considered positive, the detection rate increased to 40.9%, representing a 12.1% improvement over Xpert Ultra alone.

Conclusion

FujiLAM II shows suboptimal sensitivity for childhood TB diagnosis, with better sensitivity in children under five years, HIV-positive, or malnourished, and may add value to current diagnostic algorithms.