Department of Clinical Laboratories, University of Fukui, Fukui, Japan.
J Clin Microbiol. 2012 Nov;50(11):3604-8. doi: 10.1128/JCM.01654-12. Epub 2012 Aug 29.
Early detection of tuberculosis (TB) is essential for infection control. The geneCube (Toyobo) is a novel fully automated gene analyzer that can amplify target DNAs within 60 min. In this study, we evaluated the ability of the geneCube to directly detect Mycobacterium tuberculosis complex (MTBC) and Mycobacterium avium complex (MAC) in clinical specimens. The results were then compared with those obtained using conventional culture, microscopy, and the Cobas Amplicor assay (Roche). We examined a total of 516 frozen samples from 69 patients who showed culture-positive infection (73 samples; 39 MTBC, 32 MAC, and 2 mixed infections) and from 354 patients who were culture negative (443 samples). Assays using the geneCube had a sensitivity of 85.4% and a specificity of 99.8% for detection of MTBC and a sensitivity of 85.3% and a specificity of 99.8% for detection of MAC. These results are similar to those obtained using the Amplicor system but were obtained much more rapidly (1 h with the geneCube versus 5.5 h with the Amplicor system). The geneCube thus enables a significant shortening of the assay time with no loss of sensitivity or specificity.
结核病（TB）的早期检测对于感染控制至关重要。基因Cube（东邦）是一种新型的全自动基因分析仪，可在 60 分钟内扩增目标 DNA。在这项研究中，我们评估了基因Cube 直接检测临床标本中的结核分枝杆菌复合群（MTBC）和鸟分枝杆菌复合群（MAC）的能力。然后将结果与传统培养、显微镜检查和 Cobas Amplicor 检测（罗氏）的结果进行比较。我们共检查了 69 例培养阳性感染患者的 516 个冷冻样本（73 个样本；39 个 MTBC，32 个 MAC，2 个混合感染）和 354 例培养阴性患者的 443 个样本。基因Cube 检测 MTBC 的灵敏度为 85.4%，特异性为 99.8%，检测 MAC 的灵敏度为 85.3%，特异性为 99.8%。这些结果与 Amplicor 系统相似，但检测速度快得多（基因Cube 用时 1 小时，Amplicor 系统用时 5.5 小时）。因此，基因Cube 可以显著缩短检测时间，而不会降低敏感性或特异性。
