Abstract
TB is the leading cause of HIV/AIDS-related deaths globally. New diagnostic tools are urgently needed to avert deaths from undiagnosed HIV-associated TB. Although simple assays that detect lipoarabinomannan (LAM) in urine have been commercially available for years, their specific role and utility were initially misunderstood, such that they have been slower to emerge from the diagnostics pipeline than otherwise might have been expected. In this article, we review and explain how urine-LAM assays should be understood as diagnostics for disseminated TB in HIV-positive patients with advanced immunodeficiency, in whom haematogenous TB dissemination to the kidneys serves as the primary mechanism by which LAM enters the urine. These insights are critical for the appropriate design of studies to evaluate these assays and to understand how they might be most usefully implemented. This understanding also supports the 2015 WHO recommendations on the restricted use of these assays in sick HIV-positive patients with advanced immunodeficiency.
Highlights
In this new era of the United Nations Sustainable Development Goals (SDGs), the international community has committed to ending the HIV/AIDS and TB epidemics by 2030.1 In 2014, the World Health Assembly adopted the WHO’s post-2015 End TB Strategy, with targets to assess progress using data from 2015 as the baseline.[2]
Diagnostic accuracy studies have found the utility of urine-LAM assays to be almost entirely restricted to HIV-positive adults with advanced immunodeficiency.[7]
Understanding the mechanism of LAMantigenuria directly explains why urine LAM-assays have utility restricted to a defined patient group and why the earlier diagnostic accuracy studies focusing on other patient groups generated largely unfavourable data
Summary
In this new era of the United Nations Sustainable Development Goals (SDGs), the international community has committed to ending the HIV/AIDS and TB epidemics by 2030.1 In 2014, the World Health Assembly adopted the WHO’s post-2015 End TB Strategy, with targets to assess progress using data from 2015 as the baseline.[2]. Wood et al 201215 Lawn et al 201221 Blakemore et al 201019 Manabe et al 201428 Nakiyingi et al 201529 Nakiyingi et al 201430 Lawn & Kerkhoff 201531 Lanjewar et al 201125 Ansari et al 200224 Cox et al 201517 Cox et al 201517 of deceased patients with LAM detected in their urine.[17] All LAM-positive patients had evidence of either renal or disseminated TB.
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