Department of Medicine, University of Cape Town, Cape Town, South Africa.
Centre for International Cooperation and Global TB Information, The Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan; Institute for Global Health, University College London, London, UK.
J Infect. 2022 Jul;85(1):40-48. doi: 10.1016/j.jinf.2022.05.010. Epub 2022 May 16.
WHO recommends urine lateral-flow lipoarabinomannan (LF-LAM) testing with AlereLAM in HIV-positive inpatients only if screening criteria are met. We assessed the performance of WHO screening criteria and alternative screening tests/strategies to guide LF-LAM testing and compared diagnostic accuracy of the WHO AlereLAM algorithm (WHO screening criteria followed by AlereLAM if screen positive) with AlereLAM and FujiLAM (a novel LF-LAM test) testing in all HIV-positive inpatients.
We searched MEDLINE, Embase, and Cochrane Library from Jan 1, 2011 to March 1, 2020 for studies among adult/adolescent HIV-positive inpatients regardless of tuberculosis signs and symptoms. The reference standards were (1) AlereLAM or FujiLAM for screening tests/strategies and (2) culture or Xpert for AlereLAM/FujiLAM. We determined proportion of inpatients eligible for AlereLAM using WHO screening criteria; assessed accuracy of WHO criteria and alternative screening tests/strategies to guide LF-LAM testing; compared accuracy of WHO AlereLAM algorithm with AlereLAM/FujiLAM testing in all; and determined diagnostic yield of AlereLAM, FujiLAM, and Xpert MTB/RIF (Xpert). We estimated pooled proportions with a random-effects model, assessed diagnostic accuracy using random-effects bivariate models, and assessed diagnostic yield descriptively.
We obtained data from all 5 identified studies (n = 3,504). The pooled proportion of inpatients eligible for AlereLAM using WHO criteria was 93% (95%CI 91, 95). Among screening tests/strategies to guide LF-LAM testing, WHO criteria, C-reactive protein (≥5 mg/L), and CD4 count (<200 cells/μL) had high sensitivities but low specificities; cough (≥2 weeks), hemoglobin (<8 g/dL), body mass index (<18.5 kg/m), lymphadenopathy, and WHO-defined danger signs had higher specificities but suboptimal sensitivities. AlereLAM in all had the same sensitivity (62%) and specificity (88%) as WHO AlereLAM algorithm. Sensitivity of FujiLAM and AlereLAM was 69% and 48%, while specificity was 88% and 96%, respectively. In 2 studies that collected sputum and non-sputum samples for Xpert and/or culture, diagnostic yield of sputum Xpert was 40-41%, AlereLAM was 39-76%, and urine Xpert was 35-62%. In one study, FujiLAM diagnosed 80% of tuberculosis cases (vs 39% for AlereLAM), and sputum Xpert combined with AlereLAM, urine Xpert, or FujiLAM diagnosed 61%, 81%, and 92% of all cases, respectively.
WHO criteria and alternative screening tests/strategies have limited utility in guiding LF-LAM testing, suggesting that AlereLAM testing in all HIV-positive medical inpatients be implemented. Routine FujiLAM may improve tuberculosis diagnosis.
None.
世卫组织建议仅在符合筛查标准的情况下，对 HIV 阳性住院患者使用 AlereLAM 进行尿液侧向流脂阿拉伯甘露聚糖（LF-LAM）检测。我们评估了世卫组织筛查标准和替代筛查测试/策略的性能，以指导 LF-LAM 检测，并比较了世卫组织 AlereLAM 算法（符合世卫组织筛查标准后如果筛查阳性则进行 AlereLAM）与 AlereLAM 和 FujiLAM（一种新型 LF-LAM 检测）在所有 HIV 阳性住院患者中的诊断准确性。
我们检索了 MEDLINE、Embase 和 Cochrane 图书馆，从 2011 年 1 月 1 日至 2020 年 3 月 1 日，纳入了无论是否存在结核病迹象和症状的成年/青少年 HIV 阳性住院患者的研究。参考标准是（1）用于筛查测试/策略的 AlereLAM 或 FujiLAM 和（2）用于 AlereLAM/FujiLAM 的培养或 Xpert。我们确定了使用世卫组织筛查标准的 AlereLAM 适合患者的比例；评估了世卫组织标准和替代筛查测试/策略指导 LF-LAM 检测的准确性；比较了所有患者中世卫组织 AlereLAM 算法与 AlereLAM/FujiLAM 检测的准确性；并确定了 AlereLAM、FujiLAM 和 Xpert MTB/RIF（Xpert）的诊断产量。我们使用随机效应模型汇总了比例，使用随机效应二变量模型评估了诊断准确性，并进行了描述性诊断产量评估。
我们从所有 5 项确定的研究中获取了数据（n=3504）。使用世卫组织标准，适合 AlereLAM 检测的住院患者比例为 93%（95%CI 91，95）。在用于指导 LF-LAM 检测的筛查测试/策略中，世卫组织标准、C 反应蛋白（≥5mg/L）和 CD4 计数（<200 细胞/μL）具有较高的敏感性，但特异性较低；咳嗽（≥2 周）、血红蛋白（<8g/dL）、体重指数（<18.5kg/m）、淋巴结病和世卫组织定义的危险征象具有较高的特异性，但敏感性不理想。所有 AlereLAM 的敏感性（62%）和特异性（88%）与世卫组织 AlereLAM 算法相同。FujiLAM 和 AlereLAM 的敏感性分别为 69%和 48%，特异性分别为 88%和 96%。在 2 项同时收集痰液和非痰液样本进行 Xpert 和/或培养的研究中，痰液 Xpert 的诊断产量为 40-41%，AlereLAM 为 39-76%，尿液 Xpert 为 35-62%。在一项研究中，FujiLAM 诊断了 80%的结核病病例（而 AlereLAM 为 39%），Xpert 联合 AlereLAM、尿液 Xpert 或 FujiLAM 分别诊断了 61%、81%和 92%的所有病例。
世卫组织标准和替代筛查测试/策略在指导 LF-LAM 检测方面的实用性有限，这表明应在所有 HIV 阳性住院患者中实施 AlereLAM 检测。常规使用 FujiLAM 可能会改善结核病诊断。
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