Ann Lab Med 2018; 38(6): 569-577  https://doi.org/10.3343/alm.2018.38.6.569
Detection of Rifampicin- and Isoniazid-Resistant Mycobacterium tuberculosis Using the Quantamatrix Multiplexed Assay Platform System
Hye-young Wang, M.S.1, Young Uh, M.D.2, Seoyong Kim, B.S.3, Eunjin Cho, M.S.4, Jong Seok Lee, Ph.D.4, and Hyeyoung Lee, Ph.D.3
1Optipharm, Inc., Wonju Eco Environmental Technology Center, Wonju, Korea; 2Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea; 3Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Korea; 4Department of Microbiology, International Tuberculosis Research Center, Changwon, Korea
Corresponding author: Hyeyoung Lee
https://orcid.org/0000-0003-1572-5250
Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju 26426, Korea
Tel: +82-33-760-2740
Fax: +82-33-760-2561
E-mail: hyelee@yonsei.ac.kr
Co-corresponding author: Young Uh
https://orcid.org/0000-0002-2879-7870
Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju 26426, Korea
Tel: +82-33-741-1592
Fax: +82-33-731-0506
E-mail: u931018@yonsei.ac.kr
Received: August 4, 2017; Revised: February 2, 2018; Accepted: July 4, 2018; Published online: November 1, 2018.
© Korean Society for Laboratory Medicine. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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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