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Prospective multicentre accuracy evaluation of the FUJIFILM SILVAMP TB LAM test for the diagnosis of tuberculosis in people living with HIV demonstrates lot-to-lot variability

Prospective Multicentre Evaluation of FUJIFILM SILVAMP TB LAM Test

Key Findings

A clinical trial evaluated the diagnostic accuracy of the urine-based lipoarabinomannan assay FUJIFILM SILVAMP TB LAM (FujiLAM) for tuberculosis in people living with HIV across seven high-burden countries.

Overall, the FujiLAM demonstrated a sensitivity of 54.4% and specificity of 85.2% against the extended mycobacterial reference standard (eMRS). However, there was significant variability in performance across different testing sites and lots used in the study.

Practical Solutions

While the current variability limits the clinical utility of FujiLAM, the lipoarabinomannan biomarker still shows promise for tuberculosis diagnostics, highlighting the need for further refinement.

Value

This evaluation emphasizes the importance of ongoing research and development in point-of-care tuberculosis diagnostics, with the potential to improve patient care and outcomes.

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