Centre for Infectious Diseases Research in Zambia, Lusaka, Zambia
These authors contributed equally to this work.
Eur Respir J. 2021 Nov 18;58(5). doi: 10.1183/13993003.03999-2020. Print 2021 Nov.
A novel, rapid, point-of-care urine-based lipoarabinomannan assay (Fujifilm SILVAMP TB LAM ("FujiLAM")) has previously demonstrated substantially higher sensitivity for tuberculosis (TB) compared with the commercially available Determine TB LAM assay using biobanked specimens. However, FujiLAM has not been prospectively evaluated using fresh urine specimens. Therefore, we determined the diagnostic accuracy of FujiLAM among HIV-positive and HIV-negative outpatients with presumptive TB in Zambia.
Adult (≥18 years old) presumptive TB patients presenting to two outpatient public health facilities in Lusaka were included. All patients submitted sputa samples for smear microscopy, Xpert MTB/RIF and mycobacterial culture, and urine samples for the FujiLAM assay. Microbiologically confirmed TB was defined by the detection of in sputum using culture; this served as the reference standard to assess the diagnostic accuracy of FujiLAM.
151 adults with paired sputum microbiological tests and urine FujiLAM results were included; 45% were HIV-positive. Overall, 34 out of 151 (23%) patients had culture-confirmed pulmonary TB. The overall sensitivity and specificity of FujiLAM was 77% (95% CI 59-89%) and 92% (95% CI 86-96%), respectively. FujiLAM's sensitivity among HIV-positive patients was 75% (95% CI 43-95%) compared with 75% (95% CI 51-91%) among HIV-negative patients. The sensitivity of FujiLAM in patients with smear-positive, confirmed pulmonary TB was 87% (95% CI 60-98%) compared with 68% (95% CI 43-87%) among patients with smear-negative, confirmed pulmonary TB.
FujiLAM demonstrated high sensitivity for the detection of TB among both HIV-positive and HIV-negative adults, and also demonstrated good specificity despite the lack of systematic extrapulmonary sampling to inform a comprehensive microbiological reference standard.
一种新型、快速、即时尿液脂阿拉伯甘露聚糖检测试剂盒（富士胶片 SILVAMP TB LAM（“FujiLAM”））之前已经证明，与使用生物银行标本的商业上可获得的 Determine TB LAM 检测试剂盒相比，对结核病（TB）的敏感性显著提高。然而，FujiLAM 尚未使用新鲜尿液标本进行前瞻性评估。因此，我们在赞比亚对疑似结核病的 HIV 阳性和 HIV 阴性门诊患者中确定了 FujiLAM 的诊断准确性。
纳入了在卢萨卡的两家门诊公共卫生机构就诊的成年（≥18 岁）疑似结核病患者。所有患者均提交了痰液样本进行涂片显微镜检查、Xpert MTB/RIF 和分枝杆菌培养，以及尿液样本进行 FujiLAM 检测。通过培养检测到痰液中的 来定义微生物学确诊的结核病；这作为评估 FujiLAM 诊断准确性的参考标准。
共纳入了 151 例具有配对痰液微生物学检测和尿液 FujiLAM 结果的成年人，其中 45%为 HIV 阳性。总体而言，151 例患者中有 34 例（23%）经培养确诊为肺结核。FujiLAM 的总体敏感性和特异性分别为 77%（95%CI 59-89%）和 92%（95%CI 86-96%）。HIV 阳性患者中 FujiLAM 的敏感性为 75%（95%CI 43-95%），HIV 阴性患者中为 75%（95%CI 51-91%）。在涂片阳性、确诊肺结核患者中，FujiLAM 的敏感性为 87%（95%CI 60-98%），而在涂片阴性、确诊肺结核患者中为 68%（95%CI 43-87%）。
FujiLAM 在 HIV 阳性和 HIV 阴性成人中均显示出对结核病检测的高敏感性，并且尽管缺乏系统的肺外采样来提供全面的微生物学参考标准，但也表现出良好的特异性。
