Moon Se Hoon, Kim Eun Jin, Tomono Jun, Miyamoto Shigehiko, Mitarai Satoshi, Kim Dong Wook, Seki Mitsuko
Department of Pharmacy, College of Pharmacy, Hanyang University, Ansan, Republic of Korea.
Institute of Pharmacological Research, Hanyang University, Ansan, Republic of Korea.
J Med Microbiol. 2015 Nov;64(11):1335-1340. doi: 10.1099/jmm.0.000164. Epub 2015 Sep 2.
Tuberculosis (TB), an infectious disease caused by Mycobacterium tuberculosis complex (MTC), remains one of the leading causes of death in the world. In Korea, the current prevalence of multidrug-resistant TB (MDR-TB) poses a major problem. The most common method for diagnosing TB in developing countries is sputum smear microscopy; however, the sensitivity of this test is relatively low and it usually requires well-trained laboratory staff. Cultures of MTC require up to several weeks in sophisticated facilities, such as Biosafety Level 3. Effective diagnostic techniques are necessary to control TB. In Korea, we evaluated a loop-mediated isothermal amplification (LAMP) assay targeting the hspX gene (TB-hspX-LAMP) of MTC. For clinical evaluation, culture confirmation, smear microscopy and TB-hspX-LAMP were performed on 303 sputum specimens obtained from suspected TB patients in Korea. The sensitivity, specificity, positive predictive value and negative predictive value of TB-hspX-LAMP were 71.1, 98.8, 91.4 and 95.1%, respectively, compared with TB culture, which is the gold standard for diagnosis of TB. In contrast, the comparable values of smear microscopy were 24.4, 98.1, 68.8 and 88.2%, respectively. Therefore, we concluded that TB-hspX-LAMP was superior to the use of smear microscopy for the detection of MTC in sputum specimens in clinical settings in Korea.
结核病（TB）是由结核分枝杆菌复合群（MTC）引起的一种传染病，仍然是全球主要死因之一。在韩国，耐多药结核病（MDR-TB）的当前流行情况构成了一个重大问题。在发展中国家，诊断结核病最常用的方法是痰涂片显微镜检查；然而，该检测的灵敏度相对较低，并且通常需要训练有素的实验室工作人员。在诸如生物安全3级的先进设施中培养MTC需要长达数周时间。有效的诊断技术对于控制结核病是必要的。在韩国，我们评估了一种针对MTC的hspX基因的环介导等温扩增（LAMP）检测法（TB-hspX-LAMP）。为了进行临床评估，对从韩国疑似结核病患者获得的303份痰标本进行了培养确认、涂片显微镜检查和TB-hspX-LAMP检测。与作为结核病诊断金标准的结核菌培养相比，TB-hspX-LAMP的灵敏度、特异性、阳性预测值和阴性预测值分别为71.1%、98.8%、91.4%和95.1%。相比之下，涂片显微镜检查的相应值分别为24.4%、98.1%、68.8%和88.2%。因此，我们得出结论，在韩国的临床环境中，TB-hspX-LAMP在检测痰标本中的MTC方面优于涂片显微镜检查。
