BACKGROUND: The Fujifilm SILVAMP TB LAM (FujiLAM) assay, a point-of-care test detecting urine-based lipoarabinomannans, has demonstrated notable diagnostic accuracy for TB. However, FujiLAM exhibits lot-to-lot variability, limiting its clinical use. A new version of the product, Fujifilm SILVAMP TB LAM II (FujiLAM II), was developed to address this issue. This study evaluated the lot-to-lot variability and diagnostic accuracy of the FujiLAM II. METHODS: We assessed three lots of FujiLAM II using 158 biobanked, frozen urine specimens from people living with HIV (PLHIV): 72 TB-positive and 86 TB-negative, according to the microbiological reference standard. RESULTS: Independent proportions of the results among the three FujiLAM II lots did not differ (Cochrane CONCLUSION: The FujiLAM II demonstrated no lot-to-lot variability and exhibited high sensitivity and specificity for TB diagnosis in patients with CD4 cell counts <
200 cells/µL. The FujiLAM II enhanced reproducibility as a TB diagnostic tool in PLHIV.