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http://dx.doi.org/10.3343/alm.2018.38.6.569

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)
Publication Information
Annals of Laboratory Medicine / v.38, no.6, 2018 , pp. 569-577 More about this Journal
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
Mycobacterium tuberculosis complex; Rifampicin; Isoniazid; Drug susceptibility testing; Quantamatrix Multiplexed Assay Platform;
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