Biomedical Science Letters (대한의생명과학회지)

The Korean Society for Biomedical Laboratory Sciences (대한의생명과학회)
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Comparison of the Three Molecular Diagnostic Assays for Molecular Identification of Mycobacterium tuberculosis and Nontuberculous Mycobacteria Species in Sputum Samples

  • Bae, Jinyoung (Department of Clinical Laboratory Science, College of Health Sciences, Catholic University of Pusan) ;
  • Park, Sung-Bae (Department of Clinical Laboratory Science, College of Health Sciences, Catholic University of Pusan) ;
  • Kim, Ji-Hoi (YD R&D Center, YD Diagnostics) ;
  • Kang, Mi Ran (YD R&D Center, YD Diagnostics) ;
  • Lee, Kyung Eun (Department of Clinical Laboratory Science, College of Health Sciences, Catholic University of Pusan) ;
  • Kim, Sunghyun (Department of Clinical Laboratory Science, College of Health Sciences, Catholic University of Pusan) ;
  • Jin, Hyunwoo (Department of Clinical Laboratory Science, College of Health Sciences, Catholic University of Pusan)
  • Received : 2020.06.25
  • Accepted : 2020.07.24
  • Published : 2020.09.30
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Abstract

Mycobacterium tuberculosis (MTB) continues to be one of the main causative agents of tuberculosis (TB); moreover, the incidence of nontuberculous mycobacteria (NTM) infections has been rising gradually in both immunocompromised and immunocompetent patients. Precise and rapid detection and identification of MTB and NTM in respiratory specimens are thus important for MTB infection control. Molecular diagnostic methods based on the nucleic acid amplification test (NAAT) are known to be rapid, sensitive, and specific compared to the conventional acid-fast bacilli (AFB) smear and mycobacterial culture methods. In the present study, the clinical performances of three commercial molecular diagnostic assays, namely TB/NTM PCR (Biocore), MolecuTech Real MTB-ID® (YD Diagnostics), and REBA Myco-ID® (YD Diagnostics), were evaluated with a total of 92 respiratory specimens (22 AFB smear positives and 67 AFB smear negatives). The sensitivity and specificity of TB/NTM PCR were 100% and 75.81%, respectively. The corresponding values of MolecuTech Real MTB-ID® and REBA Myco-ID® were 56.52% and 90.32%, and 56.52% and 82.26%, respectively. TB/NTM PCR showed the highest sensitivity; however, the concordant rate was 10% compared with sequence analysis. Although MolecuTech Real MTB-ID® showed lower sensitivity, its specificity was the highest among the three methods. REBA Myco-ID® allowed accurate classification of NTM species; therefore, it was the most specific diagnostic method. Of the three PCR-based methods, MolecuTech Real MTB-ID® showed the best performance. This method is expected to enable rapid and accurate identification of MTB and NTM.

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References

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