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

Summary

Diagnostic accuracy and inter-lot variability evaluation of the redesigned Fujifilm SILVAMP TB LAM II urine lateral-flow assay, on biobanked specimens from two prospective hospital studies in Cameroon. 798 people living with HIV tested January–March 2025, 128 (16%) with microbiologically confirmed TB. Against a reference standard of two sputum liquid cultures plus sputum, urine, and blood Xpert Ultra, FujiLAM II reached 49% sensitivity (95% CI 40–58%) against 35% for AlereLAM, and 96% specificity (95% CI 94–97%) against 92%. Across four manufacturing lots, positivity ranged 37–42% with no significant difference (Cochran's Q = 4.2, P = 0.2), resolving the inter-lot variability that affected the original assay.