Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Ludwig Maximilians University Munich, Munchen, Germany
Department of Paediatrics, University of Oxford, Oxford, UK.
BMJ Paediatr Open. 2022 Jul;6(1). doi: 10.1136/bmjpo-2022-001447.
Childhood tuberculosis (TB) remains underdiagnosed. The novel lateral flow FujiLAM assay detects lipoarabinomannan (LAM) in urine, but data on performance in children remain limited.
We conducted a systematic review assessing the diagnostic performance of FujiLAM for diagnosing paediatric TB. The last search was conducted in November 2021.
We included three studies with data from 698 children for FujiLAM. For FujiLAM, sensitivity using a microbiological reference standard were 60% (95% CI 15 to 95), 42% (95% CI 31 to 53) and 63% (95% CI 50 to 75), respectively. Specificity was 93% (95% CI 85 to 98), 92% (95% CI 85 to 96) and 84% (95% CI 80 to 88). Using a composite reference standard, sensitivity was 11% (95% CI 4 to 22), 27% (95% CI 20 to 34) and 33% (95% CI 26 to 40), and specificity was 92% (95% CI 73 to 99), 97% (95% CI 87 to 100) and 85% (95% CI 79 to 89). Subgroup analyses for sensitivity of FujiLAM in children living with HIV (CLHIV) compared with those who were negative for HIV infection were inconsistent across studies. Among CLHIV, sensitivity appeared higher in those with greater immunosuppression, although wide CIs limit the interpretation of observed differences. Meta-analysis was not performed due to considerable study heterogeneity.
The high specificity of FujiLAM demonstrates its potential as a point-of-care (POC) rule-in test for diagnosing paediatric TB. As an instrument-free POC test that uses an easy-to-obtain specimen, FujiLAM could significantly improve TB diagnosis in children in low-resource settings, however the small number of studies available highlight that further data are needed. Key priorities to be addressed in forthcoming paediatric evaluations include prospective head-to-head comparisons with AlereLAM using fresh specimens, specific subgroup analysis in CLHIV and extrapulmonary disease and studies in different geographical locations.CRD42021270761.
儿童结核病（TB）仍未得到充分诊断。新型 FujiLAM 侧向流动检测法可检测尿液中的脂阿拉伯甘露聚糖（LAM），但针对儿童的检测性能数据仍有限。
我们进行了一项系统评价，评估 FujiLAM 诊断儿童结核病的诊断性能。最后一次搜索是在 2021 年 11 月进行的。
我们纳入了三项包含 698 名儿童数据的研究来评估 FujiLAM。对于 FujiLAM，基于微生物学参考标准的灵敏度分别为 60%（95%CI 15 至 95）、42%（95%CI 31 至 53）和 63%（95%CI 50 至 75）。特异性分别为 93%（95%CI 85 至 98）、92%（95%CI 85 至 96）和 84%（95%CI 80 至 88）。使用复合参考标准时，灵敏度分别为 11%（95%CI 4 至 22）、27%（95%CI 20 至 34）和 33%（95%CI 26 至 40），特异性分别为 92%（95%CI 73 至 99）、97%（95%CI 87 至 100）和 85%（95%CI 79 至 89）。针对 FujiLAM 在 HIV 感染者（CLHIV）中的敏感性与 HIV 阴性个体的敏感性的亚组分析结果在各研究中不一致。在 CLHIV 中，免疫抑制程度更高的个体中 FujiLAM 的敏感性似乎更高，尽管广泛的 CI 限制了观察到的差异的解释。由于研究之间存在较大的异质性，因此未进行荟萃分析。
FujiLAM 具有较高的特异性，表明其有潜力成为一种用于诊断儿童结核病的即时检测点（POC）规则。作为一种无仪器的 POC 检测方法，它使用易于获取的标本，可能会显著改善资源匮乏环境下儿童的结核病诊断，但目前可获得的研究数量有限，这突显了需要进一步的数据。即将进行的儿科评估中的优先事项包括使用新鲜标本与 AlereLAM 进行前瞻性头对头比较、在 CLHIV 和肺外疾病中进行特定的亚组分析以及在不同地理位置进行研究。CRD42021270761。
