Department of Mycobacterium Reference and Research, Bacteriology Division, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan.
Int J Tuberc Lung Dis. 2011 Sep;15(9):1211-7, i. doi: 10.5588/ijtld.10.0629.
A new loop-mediated isothermal amplification (LAMP) test kit, including a simple DNA extraction device for the detection of Mycobacterium tuberculosis complex, was developed for commercial use and evaluated for its usefulness in diagnosing tuberculosis (TB).
The LAMP test was performed using untreated and N-acetyl-L-cysteine (NALC) NaOH-treated sputum specimen. The efficiency of the kit was compared with other conventional laboratory examinations, including other nucleic acid amplification (NAA) tests.
The sensitivity of LAMP using raw sputum (direct LAMP) in smear- and culture-positive specimens was 98.2% (95%CI 94.9-99.4), while the sensitivity in smear-negative, culture-positive specimens was 55.6% (95%CI 43.4-68.0). The diagnostic sensitivity of direct LAMP for the diagnosis of individuals with TB was 88.2% (95%CI 81.4-92.7). The sensitivity values of direct LAMP were slightly, but not statistically significantly lower than those of Cobas Amplicor MTB and TRC Rapid MTB, while the sensitivity of the LAMP test using NALC-NaOH treated sputum was significantly lower than other NAA tests (P < 0.05) for smear-negative, culture-positive specimens. The new commercial version of the LAMP kit was easy to handle and yielded results within 1 h of receiving sputum specimens.
This test is considered a promising diagnostic tool for TB, even for peripheral laboratories with limited equipment, such as those in developing countries.
一种新的环介导等温扩增（LAMP）检测试剂盒，包括一种用于检测结核分枝杆菌复合体的简单 DNA 提取装置，已被开发用于商业用途，并评估其在诊断结核病（TB）方面的实用性。
LAMP 检测使用未经处理和 N-乙酰-L-半胱氨酸（NALC）NaOH 处理的痰液标本进行。试剂盒的效率与其他常规实验室检查，包括其他核酸扩增（NAA）检测进行比较。
直接 LAMP 检测（直接 LAMP）在涂片和培养阳性标本中的灵敏度为 98.2%（95%CI 94.9-99.4），而在涂片阴性、培养阳性标本中的灵敏度为 55.6%（95%CI 43.4-68.0）。直接 LAMP 对个体结核病的诊断灵敏度为 88.2%（95%CI 81.4-92.7）。直接 LAMP 的灵敏度值略低于，但无统计学意义低于 Cobas Amplicor MTB 和 TRC Rapid MTB，而 LAMP 检测使用 NALC-NaOH 处理的痰液的灵敏度明显低于其他 NAA 检测（P<0.05）在涂片阴性、培养阳性标本中。新的商业版 LAMP 试剂盒易于操作，在收到痰标本后 1 小时内即可得出结果。
即使对于设备有限的外围实验室，如发展中国家的实验室，该检测也被认为是一种很有前途的结核病诊断工具。
