article · PLoS ONE
A prospective clinical trial across seven high-burden countries evaluated the FUJIFILM SILVAMP TB LAM (FujiLAM) test, a rapid urine-based diagnostic designed to detect tuberculosis at the point of care in people living with HIV. Assessing 1,637 HIV-positive inpatients and outpatients against an extended mycobacterial reference standard, the test achieved an overall sensitivity of 54.4% and an overall specificity of 85.2%. However, performance differed substantially across study locations, with sensitivity ranging from 26.5% to 73.2% and specificity between 75.0% to 96.5%. Further analysis revealed significant variation between the six different production lots used during the trial. Because of this substantial batch variability, the current version of the test is deemed too inconsistent for routine clinical decision-making, even though targeting the urine lipoarabinomannan biomarker remains a viable strategy for non-sputum tuberculosis screening.
Diagnosing tuberculosis in people living with HIV is difficult because standard sputum tests are often hard to obtain or produce false negatives. Non-sputum, point-of-care urine tests offer a much easier diagnostic route. However, establishing reliable manufacturing consistency is essential, as wide performance swings between test batches can lead to misdiagnosis or missed infections in vulnerable clinic populations.
The evaluated technology is a rapid point-of-care urine test aimed at frontline clinicians diagnosing tuberculosis in HIV-positive patients. While designed as a near-market clinical product, significant lot-to-lot manufacturing variability means the current test version cannot yet be recommended for clinical decision-making. Commercial deployment will require manufacturing improvements to ensure consistent batch quality before clinical adoption is viable.
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There is an urgent need for rapid, non-sputum point-of-care diagnostics to detect tuberculosis. This prospective trial in seven high tuberculosis burden countries evaluated the diagnostic accuracy of the point-of-care urine-based lipoarabinomannan assay FUJIFILM SILVAMP TB LAM (FujiLAM) among inpatients and outpatients living with HIV. Diagnostic performance of FujiLAM was assessed against a mycobacterial reference standard (sputum culture, blood culture, and Xpert Ultra from urine and sputum at enrollment, and additional sputum culture ≤7 days from enrollment), an extended mycobacterial reference standard (eMRS), and a composite reference standard including clinical evaluation. Of 1637 participants considered for the analysis, 296 (18%) were tuberculosis positive by eMRS. Median age was 40 years, median CD4 cell count was 369 cells/ul, and 52% were female. Overall FujiLAM sensitivity was 54·4% (95% CI: 48·7-60·0), overall specificity was 85·2% (83·2-87·0) against eMRS. Sensitivity and specificity estimates varied between sites, ranging from 26·5% (95% CI: 17·4%-38·0%) to 73·2% (60·4%-83·0%), and 75·0 (65·0%-82·9%) to 96·5 (92·1%-98·5%), respectively. Post-hoc exploratory analysis identified significant variability in the performance of the six FujiLAM lots used in this study. Lot variability limited interpretation of FujiLAM test performance. Although results with the current version of FujiLAM are too variable for clinical decision-making, the lipoarabinomannan biomarker still holds promise for tuberculosis diagnostics. The trial is registered at clinicaltrials.gov (NCT04089423).
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DOI: 10.1371/journal.pone.0303846
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