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Detection of Rifampicin- and Isoniazid-Resistant Mycobacterium tuberculosis Using the Quantamatrix Multiplexed Assay Platform System

  • Wang, Hye-young (Optipharm, Inc., Wonju Eco Environmental Technology Center) ;
  • Uh, Young (Department of Laboratory Medicine, Yonsei University Wonju College of Medicine) ;
  • Kim, Seoyong (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University) ;
  • Cho, Eunjin (Department of Microbiology, International Tuberculosis Research Center) ;
  • Lee, Jong Seok (Department of Microbiology, International Tuberculosis Research Center) ;
  • Lee, Hyeyoung (Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University)
  • Received : 2017.08.04
  • Accepted : 2018.07.04
  • Published : 2018.11.01

Abstract

Background: The increasing prevalence of drug-resistant tuberculosis (TB) infection represents a global public health emergency. We evaluated the usefulness of a newly developed multiplexed, bead-based bioassay (Quantamatrix Multiplexed Assay Platform [QMAP], QuantaMatrix, Seoul, Korea) to rapidly identify the Mycobacterium tuberculosis complex (MTBC) and detect rifampicin (RIF) and isoniazid (INH) resistance-associated mutations. Methods: A total of 200 clinical isolates from respiratory samples were used. Phenotypic anti-TB drug susceptibility testing (DST) results were compared with those of the QMAP system, reverse blot hybridization (REBA) MTB-MDR assay, and gene sequencing analysis. Results: Compared with the phenotypic DST results, the sensitivity and specificity of the QMAP system were 96.4% (106/110; 95% confidence interval [CI] 0.9072-0.9888) and 80.0% (72/90; 95% CI 0.7052-0.8705), respectively, for RIF resistance and 75.0% (108/144; 95% CI 0.6731-0.8139) and 96.4% (54/56; 95% CI 0.8718-0.9972), respectively, for INH resistance. The agreement rates between the QMAP system and REBA MTB-MDR assay for RIF and INH resistance detection were 97.6% (121/124; 95% CI 0.9282-0.9949) and 99.1% (109/110; 95% CI 0.9453-1.0000), respectively. Comparison between the QMAP system and gene sequencing analysis showed an overall agreement of 100% for RIF resistance (110/110; 95% CI 0.9711-1.0000) and INH resistance (124/124; 95% CI 0.9743-1.0000). Conclusions: The QMAP system may serve as a useful screening method for identifying and accurately discriminating MTBC from non-tuberculous mycobacteria, as well as determining RIF- and INH-resistant MTB strains.

Keywords

Acknowledgement

Supported by : Korea Health Industry Development Institute (KHIDI)

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