Habeenzu Charity, Nakajima Chie, Solo Eddie, Bwalya Precious, Kajino Kiichi, Miller Mari, Kurosawa Youichi, Mudenda Victor, Kasonka Lackson, Suzuki Yasuhiko, Matsuba Takashi
University Teaching Hospital, Ministry of Health, Lusaka, Zambia.
Hokkaido University Research Center for Zoonosis Control, Sapporo, Japan.
J Infect Dev Ctries. 2017 Jun 27;11(6):440-444. doi: 10.3855/jidc.7730.
To evaluate the diagnostic performances of an in-house loop-mediated isothermal amplification (LAMP) kit and the Xpert MTB/RIF test for the diagnosis of pulmonary tuberculosis in a resource-limited setting, this study was performed at the University Teaching Hospital, Ministry of Health, the Republic of Zambia.
Two hundred sputum specimens obtained from new tuberculosis (TB) suspects were used for the evaluation of the diagnostic performance of an in-house LAMP kit in comparison with the Xpert MTB/RIF kit.
The sensitivity of in-house LAMP and Xpert MTB/RIF was 96.9% and 95.4% in smear-positive samples, 96.8% and 100% in smear-positive/culture-positive samples, and 39.1% and 73.9% in smear-negative/culture-positive samples, respectively. The specificity of in-house LAMP and MTB/RIF kits with culture was 96.5% and 94.5%, respectively. This indicated the superiority of the Xpert MTB/RIF kit; however, mechanical errors during sample processing and the insufficient quantity of samples by Xpert MTB/RIF kit occurred at 2.0% and 19.7%, respectively, comparing to the 100% accessibility of in-house LAMP.
Considering the results obtained in this study together with the easy setup with much simpler equipment, such as an aluminum heat block or water bath, in in-house LAMP compared with real-time polymerase chain reaction equipment in Xpert MTB/RIF kit, the applicability of in-house LAMP for the screening of tuberculosis directly from sputum in resource-limited setting seemed to be high.
为了评估在资源有限的环境中，一种内部环介导等温扩增（LAMP）试剂盒和Xpert MTB/RIF检测对肺结核诊断的性能，本研究在赞比亚共和国卫生部大学教学医院进行。
从新的结核病疑似患者中获取200份痰标本，用于评估内部LAMP试剂盒与Xpert MTB/RIF试剂盒相比的诊断性能。
内部LAMP和Xpert MTB/RIF在涂片阳性样本中的敏感性分别为96.9%和95.4%，在涂片阳性/培养阳性样本中分别为96.8%和100%，在涂片阴性/培养阳性样本中分别为39.1%和73.9%。内部LAMP和MTB/RIF试剂盒与培养法相比的特异性分别为96.5%和94.5%。这表明Xpert MTB/RIF试剂盒具有优越性；然而，与内部LAMP 100%的可及性相比，Xpert MTB/RIF试剂盒在样本处理过程中的机械误差和样本量不足分别为2.0%和19.7%。
结合本研究结果以及与Xpert MTB/RIF试剂盒中的实时聚合酶链反应设备相比，内部LAMP使用铝热块或水浴等设备更容易设置，在资源有限的环境中，内部LAMP直接从痰中筛查结核病的适用性似乎很高。
