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Original Research
Urine-based assays for inpatients with HIV-associated tuberculosis in rural South Africa
Submitted: 24 January 2025 | Published: 17 June 2025
About the author(s)
Mbulelo Mntonintshi, Department of Family Medicine and Rural Health, Faculty of Medicine and Health Sciences, Walter Sisulu University, Mthatha, South AfricaBianca Sossen, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
Hloni Bookholane, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
Aimee Lifson, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
Lisa Africa, Department of Medicine, Mitchells Plain Hospital, Cape Town, South Africa
René Goliath, Wellcome Centre for Infectious Disease Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa
Nicola Wearne, Division of Nephrology and Hypertension, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa
Andy Parrish, Department of Internal Medicine, Frere and Cecilia Makiwane Hospitals, Walter Sisulu University Central Deanery, Mthatha, South Africa
Graeme Meintjes, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa Wellcome Centre for Infectious Disease Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa Blizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom
Abstract
Background: Accurate non-sputum-based tuberculosis (TB) diagnostics are urgently needed to improve diagnostic yield and patient outcomes.
Objectives: To compare the diagnostic accuracy and diagnostic yield of Urine Xpert Ultra (Urine-XPU) and Urine DetermineTM TB Lipoarabinomannan (LAM) antigen test (AlereLAM) against both a microbiological and composite reference standard (MRS and CRS) in a rural, routine care setting in South Africa.
Method: Adults (≥ 18 years) with HIV had sputum, urine and blood collected for comprehensive TB testing shortly after admission. Additionally, focused assessment with sonography for HIV-associated TB (FASH) was performed. The MRS was defined by Xpert Ultra or culture-based tests for Mycobacterium tuberculosis. The CRS incorporated these mycobacterial tests, FASH findings, and clinical response to empiric TB treatment. Follow-up was conducted at 3 months.
Results: A total of 206 participants were enrolled, with a median age of 39 years and 63% were female. Using the MRS the sensitivity of AlereLAM was 45.2% (95% confidence interval [CI]: 31.2–60.1) and Urine-XPU, 59.5% (95%CI: 44.5–73.0); and the specificity of AlereLAM was 93.6% (95%CI: 88.2–96.6) and Urine-XPU 95.0% (95%CI: 90.0% – 97.6%). Urine-XPU and AlereLAM performed better than sputum Xpert Ultra (Sputum-XPU) in patients with more severe illness. Additionally, Urine-XPU showed potential for accurately detecting rifampicin resistance.
Conclusion: Urine-XPU and AlereLAM demonstrated comparable diagnostic accuracy for TB in hospitalised adults with HIV. Integrating Urine-XPU alongside AlereLAM and Sputum-XPU may improve timely and accurate diagnosis of TB and rifampicin resistance. Further research is required to optimise the diagnosis-to-treatment pathway.
Keywords
Sustainable Development Goal
Metrics
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