Department of Medical Microbiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
J Clin Lab Anal. 2013 Jul;27(4):272-6. doi: 10.1002/jcla.21596.
Loop-mediated isothermal amplification (LAMP) assay has come forward as a rapid, cost-effective molecular technique for diagnosis of tuberculosis (TB) in developing countries. This study evaluated Mycobacterium tuberculosis-specific in-house LAMP assay targeting 16s rRNA and compared it with other conventional tests and nucleic acid amplification assay (IS6110 PCR).
A total of 133 sputum specimens (103 from suspected pulmonary TB cases and 30 from non-TB controls) were subjected to conventional tests, IS6110 PCR and 16s rRNA LAMP assay.
Of the 103 patients, the maximum number of cases were found to be positive by LAMP assay, that is, in 87 (84.5%) patients, followed by culture positive in 78 (75.7%), IS6110 PCR in 74 (71.8%), and smear positive in 70 (67.9%) patients. Of the 83 smear positive and/or culture positive cases, LAMP detected 77 (92.77%) cases, and was found to be superior to IS6110 PCR, which could detect 69 (83.1%) cases; a concordance of 0.6 was obtained between the two tests using kappa statistics.
Overall, LAMP was simple and efficacious for early diagnosis of smear positive, culture positive cases as well as for confirmation of smear negative, culture negative cases, and was found to be superior to IS6110 PCR.
环介导等温扩增（LAMP）检测法作为一种在发展中国家快速、经济的分子诊断结核分枝杆菌（TB）的方法已经出现。本研究评估了针对 16s rRNA 的结核分枝杆菌特异性内部 LAMP 检测法，并将其与其他常规检测方法和核酸扩增检测（IS6110 PCR）进行了比较。
共检测了 133 份痰标本（103 份来自疑似肺结核病例，30 份来自非 TB 对照），分别进行了常规检测、IS6110 PCR 和 16s rRNA LAMP 检测。
在 103 例患者中，LAMP 检测法检测出的病例数最多，即 87 例（84.5%）患者为阳性，其次是培养阳性 78 例（75.7%）、IS6110 PCR 阳性 74 例（71.8%）、涂片阳性 70 例（67.9%）。在 83 例涂片阳性和/或培养阳性病例中，LAMP 检测出 77 例（92.77%），优于可检测出 69 例（83.1%）病例的 IS6110 PCR；两种检测方法的一致性用 Kappa 统计分析为 0.6。
总的来说，LAMP 对于早期诊断涂片阳性、培养阳性病例以及确认涂片阴性、培养阴性病例都非常简单有效，优于 IS6110 PCR。
