From the Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, KEPCO Medical CenterSunchunhyang University Medical Center, Seoul, South Korea.
NanoBioSys Inc, Sunchunhyang University Medical Center, Seoul, South Korea.
Chest. 2014 Nov;146(5):1319-1326. doi: 10.1378/chest.14-0626.
NBS LabChip G2-3 is a novel, ultrafast, chip-type portable real-time polymerase chain reaction (PCR) system. We evaluated the clinical usefulness of this system in detecting pulmonary TB and assessed its diagnostic performance compared with a conventional tube-type PCR system.
A total of 247 sputum samples were collected from patients suspected of having pulmonary TB. After the decontamination process, these samples were examined by fluorescence staining for acid-fast bacilli, cultures with both solid and liquid media, and real-time PCR with the NBS LabChip and a conventional tube-type system. The diagnostic accuracy of the NBS LabChip system and the agreement between the two assays were evaluated.
Considering mycobacterial culture results as a gold standard, the overall sensitivity and specificity of the NBS LabChip was 83.8% (95% CI, 73.8%-91.1%) and 94.0% (95% CI, 89.3%-97.1%), respectively. For the detection of TB from the smear-positive samples, the sensitivity and specificity of the NBS LabChip was 96.0% (95% CI, 86.3%-99.5%) and 83.3% (95% CI, 72.3%-95.7%), respectively. For the smear-negative samples, the sensitivity and specificity of the NBS LabChip was 63.3% (95% CI, 43.9%-80.1%) and 95.0% (95% CI, 90.4%-97.8%), respectively. There were no significant differences in the sensitivity and specificity between the NBS LabChip and a conventional tube-type system, although the NBS LabChip shortened the PCR time (27 min for 45 cycles).
The NBS LabChip G2-3 system has potential as an ultrafast, cost-effective diagnostic tool for pulmonary TB with high sensitivity and specificity.
NBS LabChip G2-3 是一种新型的、超快速的、芯片式便携式实时聚合酶链反应（PCR）系统。我们评估了该系统在检测肺结核方面的临床应用价值，并评估了其与传统管型 PCR 系统相比的诊断性能。
共收集了 247 例疑似肺结核患者的痰液样本。经过去污处理后，采用荧光染色法检测抗酸杆菌，采用固体和液体培养基培养，并采用 NBS LabChip 和传统管型系统进行实时 PCR。评估了 NBS LabChip 系统的诊断准确性和两种检测方法之间的一致性。
以分枝杆菌培养结果为金标准，NBS LabChip 的总敏感性和特异性分别为 83.8%（95%CI，73.8%-91.1%）和 94.0%（95%CI，89.3%-97.1%）。对于阳性样本的检测，NBS LabChip 的敏感性和特异性分别为 96.0%（95%CI，86.3%-99.5%）和 83.3%（95%CI，72.3%-95.7%）。对于阴性样本，NBS LabChip 的敏感性和特异性分别为 63.3%（95%CI，43.9%-80.1%）和 95.0%（95%CI，90.4%-97.8%）。虽然 NBS LabChip 缩短了 PCR 时间（45 个循环用时 27 分钟），但与传统管型系统相比，其敏感性和特异性无显著差异。
NBS LabChip G2-3 系统具有成为一种快速、经济有效的肺结核诊断工具的潜力，具有较高的敏感性和特异性。
