Seung Hyeun Lee1, Sung-Woo Kim2, Sehyun Lee2, EunSub Kim2, Duck-Joong Kim2, Sohyun Park2, Eun Joo Lee3, Sang Yeub Lee3, Ji Sung Lee4, Chae Seung Lim5, Won-Ki Kim6, Kwang Ho In7. 1. From the Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, KEPCO Medical CenterSunchunhyang University Medical Center, Seoul, South Korea. 2. NanoBioSys Inc, Sunchunhyang University Medical Center, Seoul, South Korea. 3. Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Sunchunhyang University Medical Center, Seoul, South Korea. 4. Biostatistical Consulting Unit, Sunchunhyang University Medical Center, Seoul, South Korea. 5. Department of Laboratory Medicine, Sunchunhyang University Medical Center, Seoul, South Korea. 6. Department of Neuroscience, College of Medicine, Korea University, Sunchunhyang University Medical Center, Seoul, South Korea. 7. Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Sunchunhyang University Medical Center, Seoul, South Korea. Electronic address: khin@kumc.or.kr.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: The NBS LabChip G2-3 system has potential as an ultrafast, cost-effective diagnostic tool for pulmonary TB with high sensitivity and specificity.
BACKGROUND: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. METHODS: 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. RESULTS: 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). CONCLUSIONS: The NBS LabChip G2-3 system has potential as an ultrafast, cost-effective diagnostic tool for pulmonary TB with high sensitivity and specificity.