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Original Research: Chest Infections |

Rapid Detection of Mycobacterium tuberculosis Using a Novel Ultrafast Chip-Type Real-Time Polymerase Chain Reaction SystemRapid Detection of Mycobacterium Tuberculosis

Seung Hyeun Lee, MD, PhD; Sung-Woo Kim, PhD; Sehyun Lee, MSc; EunSub Kim, MSc; Duck-Joong Kim, MSc; Sohyun Park, MSc; Eun Joo Lee, MD, PhD; Sang Yeub Lee, MD, PhD; Ji Sung Lee, PhD; Chae Seung Lim, MD, PhD; Won-Ki Kim, PhD; Kwang Ho In, MD, PhD
Author and Funding Information

From the Division of Respiratory and Critical Care Medicine (Dr S. H. Lee), Department of Internal Medicine, KEPCO Medical Center; NanoBioSys Inc (Dr S.-W. Kim, Mss S. Lee and Park, and Messrs E. Kim and D.-J. Kim); Division of Respiratory and Critical Care Medicine, Department of Internal Medicine (Drs E. J. Lee, S. Y. Lee, and In), Department of Laboratory Medicine (Dr Lim), and Department of Neuroscience (Dr W.-K. Kim), College of Medicine, Korea University; and Biostatistical Consulting Unit (Dr J. S. Lee), Sunchunhyang University Medical Center, Seoul, South Korea.

CORRESPONDENCE TO: Kwang Ho In, MD, PhD, Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University, 126-1, Anam-dong 5-ga, Seongbuk-gu, Seoul 136-705, South Korea; e-mail: khin@kumc.or.kr


Drs S. H. Lee and S.-W. Kim contributed equally.

FUNDING/SUPPORT: This study was supported by a grant from the Industrial Source Technology Development Program [No. 2010-10038674] of the Ministry of Knowledge Economy of the Korean government.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2014;146(5):1319-1326. doi:10.1378/chest.14-0626
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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.

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