BACKGROUND WHO guidelines recommend the lateral flow urine lipoarabinomannan assay (LF-LAM) for TB diagnosis in hospitalised HIV-positive individuals. The role of LF-LAM among ambulant patients remains less well defined. We investigated the sensitivity of LF-LAM among ambulant HIV-positive adults in primary health clinics in South Africa. METHODS We enrolled adults (aged ≥18 y) with CD4 counts of ≤150 cells/mm3 who had not received TB treatment or antiretroviral therapy in the preceding 3 or 6 mo, respectively. Research nurses performed the LF-LAM test on freshly voided urine. Results were compared with a reference standard of positive mycobacterial culture (sputum or urine). RESULTS Of 1505 (54.5% female; median age 37 y; median CD4 count 73 cells/mm3) participants, 973 (64.7%) had a mycobacterial culture result; 105/973 (10.8%) were positive for Mycobacterium tuberculosis. LF-LAM sensitivity was 41.9% (95% CI 32.3 to 51.9%) and 19.0% (95% CI 12.0 to 27.9%) using grade 1+ and grade 2+ cut-off points, respectively. Sensitivity increased with severe immunosuppression and in the presence of poor prognostic indicators (low haemoglobin, body mass index). CONCLUSIONS When used as the only TB diagnostic test, LF-LAM sensitivity is suboptimal, particularly using the grade 2+ cut-off. More sensitive tests for TB are needed that can be used in primary care settings.

中文翻译：

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在患有晚期HIV疾病的流动成年人中，侧向流动尿液lipoarabinomannan分析的敏感性：来自TB Fast Track研究的数据。

背景世卫组织指南建议在住院的HIV阳性个体中采用侧流尿脂阿拉伯糖甘露聚糖测定法（LF-LAM）进行TB诊断。LF-LAM在急诊患者中的作用尚不明确。我们在南非的初级卫生保健诊所调查了可流动的HIV阳性成年人中LF-LAM的敏感性。方法我们招募了CD4计数≤150细胞/ mm3的成年人（≥18岁），他们分别在之前的3个月或6个月内未接受结核病治疗或抗逆转录病毒治疗。研究护士对刚排空的尿液进行了LF-LAM测试。将结果与阳性分枝杆菌培养物（痰液或尿液）的参考标准进行比较。结果1505名（54.5％的女性；中位年龄37岁；中值CD4计数73个细胞/ mm3）的参与者中，有973名（64.7％）的人有分枝杆菌培养结果。105/973（10。8％）结核分枝杆菌呈阳性。使用1+级和2+级截止点，LF-LAM灵敏度分别为41.9％（95％CI 32.3至51.9％）和19.0％（95％CI 12.0至27.9％）。严重的免疫抑制和不良的预后指标（低血红蛋白，体重指数）会增加敏感性。结论当作为唯一的结核病诊断测试时，LF-LAM灵敏度次优，尤其是使用2+级截止值时。需要对结核病进行更敏感的测试，以便在初级保健机构中使用。结论当作为唯一的结核病诊断测试时，LF-LAM灵敏度次优，尤其是使用2+级截止值时。需要对结核病进行更敏感的测试，以便在初级保健机构中使用。结论当作为唯一的结核病诊断测试时，LF-LAM灵敏度次优，尤其是使用2+级截止值时。需要对结核病进行更敏感的测试，以便在初级保健机构中使用。