title: Rapid detection of Mycobacterium tuberculosis using a novel ultrafast chip-type real-time polymerase chain reaction system.
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.
authors: From the Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, KEPCO Medical CenterSunchunhyang University Medical Center, Seoul, South Korea.
authors: Seung Hyeun
authors: SH
authors: Lee
authors: NanoBioSys Inc, Sunchunhyang University Medical Center, Seoul, South Korea.
authors: Sung-Woo
authors: SW
authors: Kim
authors: NanoBioSys Inc, Sunchunhyang University Medical Center, Seoul, South Korea.
authors: Sehyun
authors: S
authors: Lee
authors: NanoBioSys Inc, Sunchunhyang University Medical Center, Seoul, South Korea.
authors: EunSub
authors: E
authors: Kim
authors: NanoBioSys Inc, Sunchunhyang University Medical Center, Seoul, South Korea.
authors: Duck-Joong
authors: DJ
authors: Kim
authors: NanoBioSys Inc, Sunchunhyang University Medical Center, Seoul, South Korea.
authors: Sohyun
authors: S
authors: Park
authors: Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Sunchunhyang University Medical Center, Seoul, South Korea.
authors: Eun Joo
authors: EJ
authors: Lee
authors: Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Sunchunhyang University Medical Center, Seoul, South Korea.
authors: Sang Yeub
authors: SY
authors: Lee
authors: Biostatistical Consulting Unit, Sunchunhyang University Medical Center, Seoul, South Korea.
authors: Ji Sung
authors: JS
authors: Lee
authors: Department of Laboratory Medicine, Sunchunhyang University Medical Center, Seoul, South Korea.
authors: Chae Seung
authors: CS
authors: Lim
authors: Department of Neuroscience, College of Medicine, Korea University, Sunchunhyang University Medical Center, Seoul, South Korea.
authors: Won-Ki
authors: WK
authors: Kim
authors: Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Sunchunhyang University Medical Center, Seoul, South Korea. Electronic address: khin@kumc.or.kr.
authors: Kwang Ho
authors: KH
authors: In
mesh_terms: D004269:DNA, Bacterial / Q000235:genetics*; D003937:Diagnosis, Differential; D004867:Equipment Design; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000235:genetics* / Q000302:isolation & purification; D012372:ROC Curve; D060888:Real-Time Polymerase Chain Reaction / Q000295:instrumentation*; D015203:Reproducibility of Results; D013183:Sputum / Q000382:microbiology*; D013997:Time Factors; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000382:microbiology
chemical_list: D004269:DNA, Bacterial