在高负担地区的一家基层实验室评估Loopamp™MTBC检测试剂盒用于诊断肺结核的效果。
Evaluation of Loopamp™MTBC detection kit for diagnosis of pulmonary tuberculosis at a peripheral laboratory in a high burden setting.
作者信息
Nguyen Van Anh Thi, Nguyen Hung Van, Dinh Thuong Van, Du Ha Hoang, Do Chinh Nhu, Marks Guy B, Nguyen Nhung Viet
机构信息
Department of Bacteriology, National Institute of Hygiene Epidemiology, Hanoi, Vietnam.
Department of Microbiology, National Lung Hospital, Hanoi, Vietnam.
出版信息
Diagn Microbiol Infect Dis. 2018 Mar;90(3):190-195. doi: 10.1016/j.diagmicrobio.2017.11.009. Epub 2017 Nov 21.
The Loopamp™MTBC detection kit (TB-LAMP) was designed to replace the sputum smear microscopy for the diagnosis of pulmonary tuberculosis. We evaluated its performance at a peripheral laboratory in Vietnam. The sensitivity of TB-LAMP was 45.5% (28.1%-63.6%), which was equal to 3-sputum smear microscopy but lower than that of Xpert MTB/RIF (87.8% [71.8%-96.6%]). In patients with culture-confirmed TB, sensitivity was 80% (51.9%-95.7%) in smear-positive and 16.7% (3.5%-41.4%) in smear-negative cases. The specificity of TB-LAMP was 95.1% (92.7%-96.9%), which was lower than that of smear microscopy (98.9% [97.5%-99.7%]) and Xpert MTB/RIF (99.3% [98.1%-99.9%]) (P<0.05). The probability of TB detection by TB-LAMP was more influenced by sample quality and viscosity than were smear microscopy, Xpert MTB/RIF, and culture. The present data do not support the use of TB-LAMP as a replacement test for smear microscopy in peripheral laboratories.
环介导等温扩增（Loopamp™）结核分枝杆菌复合群（MTBC）检测试剂盒（TB-LAMP）旨在替代痰涂片显微镜检查用于肺结核诊断。我们在越南的一家基层实验室评估了其性能。TB-LAMP的灵敏度为45.5%（28.1%-63.6%），与3次痰涂片显微镜检查相当，但低于Xpert MTB/RIF的灵敏度（87.8% [71.8%-96.6%]）。在培养确诊为结核病的患者中，涂片阳性病例的灵敏度为80%（51.9%-95.7%），涂片阴性病例的灵敏度为16.7%（3.5%-41.4%）。TB-LAMP的特异性为95.1%（92.7%-96.9%），低于涂片显微镜检查（98.9% [97.5%-99.7%]）和Xpert MTB/RIF（99.3% [98.1%-99.9%]）（P<0.05）。与涂片显微镜检查、Xpert MTB/RIF和培养相比，TB-LAMP检测结核病的概率受样本质量和黏稠度的影响更大。目前的数据不支持在基层实验室将TB-LAMP用作涂片显微镜检查的替代检测方法。
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