Department of Medical Microbiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Pediatric Pulmonology Unit, Department of Pediatrics, Advanced Paediatric Center, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Infect Dis (Lond). 2021 Nov-Dec;53(12):942-946. doi: 10.1080/23744235.2021.1963467. Epub 2021 Aug 17.
Paediatric tuberculosis remains a major public health problem in developing countries. The diagnosis of tuberculosis in children is challenging because of the paucibacillary nature of the disease, due to which more sensitive nucleic acid amplification tests are needed. In this study, we determined the accuracy of WHO endorsed TB-LAMP assay for detection of in children.
This was a prospective study conducted between March to July, 2018. A total of 177 samples from consecutive suspected TB children were received for microbiological diagnosis of TB. All tests for detection were performed in parallel (smear microscopy, mycobacterial culture, Xpert MTB/RIF and TB-LAMP). The diagnostic accuracy of index test i.e. TB LAMP were determined using mycobacterial culture as a reference standard.
Of the 177 samples, 2 (1.1%) were excluded from the study. Among 175 samples, TB-LAMP and Xpert MTB/RIF were positive in 27 (15.4%) and 25 (14.3%) samples, respectively. The sensitivity of both Xpert MTB/RIF and TB-LAMP was same, i.e. 84% (95%CI: 63.9-95.5%), when culture was considered as the reference standard. The specificity, positive predictive value and negative predictive value of TB-LAMP assay was 96% (95%CI: 91.5-98.5%), 77.8% (95%CI: 61.1-88.6%) and 97.3% (95%CI: 93.6-98.9%), respectively.
For the detection of in paediatric samples, TB-LAMP showed a sensitivity and specificity comparable to Xpert MTB/RIF.
小儿结核病仍然是发展中国家的一个主要公共卫生问题。由于疾病的菌量少，儿童结核病的诊断具有挑战性，因此需要更敏感的核酸扩增检测。在这项研究中，我们确定了世界卫生组织（WHO）推荐的 TB-LAMP 检测法在儿童中检测 的准确性。
这是一项在 2018 年 3 月至 7 月期间进行的前瞻性研究。共收到 177 例连续疑似结核病儿童的样本进行结核病的微生物学诊断。所有检测 的检测均同时进行（涂片显微镜检查、分枝杆菌培养、Xpert MTB/RIF 和 TB-LAMP）。使用分枝杆菌培养作为参考标准，确定了指标检测即 TB-LAMP 的诊断准确性。
在 177 例样本中，有 2 例（1.1%）被排除在研究之外。在 175 例样本中，TB-LAMP 和 Xpert MTB/RIF 分别在 27 例（15.4%）和 25 例（14.3%）样本中阳性。当以培养作为参考标准时，Xpert MTB/RIF 和 TB-LAMP 的敏感性相同，均为 84%（95%CI：63.9-95.5%）。TB-LAMP 检测法的特异性、阳性预测值和阴性预测值分别为 96%（95%CI：91.5-98.5%）、77.8%（95%CI：61.1-88.6%）和 97.3%（95%CI：93.6-98.9%）。
对于儿科样本中 的检测，TB-LAMP 显示出与 Xpert MTB/RIF 相当的敏感性和特异性。
