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. 2025 Aug 1;39(10):1334-1343.
doi: 10.1097/QAD.0000000000004213. Epub 2025 Apr 21.

Diagnostic accuracy of the re-engineered urinary FujiLAM2 assay amongst hospitalized adults with advanced HIV disease

Jayne Ellis  1   2 , Biyue Dai  3 , Mable Kabahubya  1 , Gila Hale  1 , Emmanuel Mande  1 , George Katende  1 , Enock Kagimu  1 , Jane Gakuru  1 , Jane Frances Ndyetukira  1 , Asmus Tukundane  1 , Tessa Adzemovic  3 , Laura J Nsangi  1 , Joseph N Jarvis  2 , Nathan C Bahr  4 , Fiona V Cresswell  2   5   6 , David B Meya  1   4 , David R Boulware  4
Affiliations

Diagnostic accuracy of the re-engineered urinary FujiLAM2 assay amongst hospitalized adults with advanced HIV disease

Jayne Ellis et al. AIDS. .

Abstract

Background: A nonsputum-based, point-of-care tuberculosis (TB) diagnostic test is a global health priority. The impact of urinary mycobacterial lipoarabinomannan (LAM) testing has been limited by the diagnostic performance of current assays. We assessed the diagnostic accuracy of the re-engineered TB-LAM SILVAMP (FujjLAM2) assay (Fujifilm, Japan) to diagnose TB amongst hospitalized adults living with advanced HIV disease.

Methods: We consecutively enrolled adults presenting with suspected meningitis at two hospitals in Uganda. We implemented a standardized TB diagnostic package: urine Alere TB lipoarabinomannan (TB-LAM), urine Xpert MTB/Rif Ultra, CSF Xpert MTB/Rif Ultra, TB CSF culture, mycobacterial blood culture and chest radiography. We performed FujiLAM2 testing on cryopreserved or fresh urine. We compared diagnostic accuracy against a composite microbiological reference standard of any positive TB test (including Alere-LAM). We assessed 30-day mortality.

Findings: We performed FujiLAM2 testing on urine of 436 hospitalized participants. The median CD4 + cell count was 34 cells/μl [interquartile range (IQR) 11-96]. Using the microbiologic reference standard, FujiLAM2 sensitivity was 34% [95% confidence interval (CI) 25-43%], and specificity was 94% (95% CI 91-96%). When grade-1 Alere TB-LAM positives were excluded, sensitivity was 38% (95% CI 27-50%). Cryopreserved specimens were threefold more frequently positive.

Interpretation: Amongst hospitalized adults with advanced HIV disease, the re-engineered FujiLAM2 urine assay had suboptimal sensitivity but high specificity for diagnosing TB disease. Antigen-antibody/protein complexes may be present accounting for better sensitivity with cryopreserved specimens.

Keywords: HIV; advanced HIV disease; lipoarabinomannan; tuberculosis.

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References

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