Ann Lab Med 2020; 40(2): 142-147  https://doi.org/10.3343/alm.2020.40.2.142
Evaluation of the QuantaMatrix Multiplexed Assay Platform for Molecular Diagnosis of Multidrug- and Extensively Drug-Resistant Tuberculosis Using Clinical Strains Isolated in Myanmar
Yunhee Chang, B.S.1, Seoyong Kim, B.S.1, Yeun Kim, Ph.D.1, Phyu Win Ei, Ph.D.1, Dasom Hwang, B.S.1, Jongseok Lee, Ph.D.2, Chulhun L Chang, M.D., Ph.D.3, and Hyeyoung Lee, Ph.D.1
1Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Korea; 2International Tuberculosis Research Center, Changwon, Korea; 3Department of Laboratory Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea
Corresponding author: Hyeyoung Lee, Ph.D.
Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, 1 Yeonsedae-gil, Wonju 26493, Korea
Tel: +82-33-760-2740 Fax: +82-33-760-2561 E-mail: Hyelee@yonsei.ac.kr
Received: May 28, 2019; Revised: August 6, 2019; Accepted: October 11, 2019; Published online: March 1, 2020.
© 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: Although the incidence of tuberculosis (TB) is decreasing, cases of multidrug-resistant (MDR) TB and extensively drug-resistant (XDR) TB continue to increase. As conventional phenotype drug susceptibility testing (pDST) takes six to eight weeks, molecular assays are widely used to determine drug resistance. we developed QuantaMatrix Multiplexed Assay Platform (QMAP) MDR/XDR assay (QuantaMatrix Inc., Seoul, Korea) that can simultaneously detect mutations related to both first- and second-line drug resistance (rifampin, isoniazid, ethambutol, fluoroquinolones, second-line injectable drugs, and streptomycin).
Methods: We used 190 clinical Mycobacterium tuberculosis (MTB) strains isolated from Myanmar, compared QMAP and pDST results, and determined concordance rates. Additionally, we performed sequence analyses for discordant results.
Results: QMAP results were 87.9% (167/190) concordant with pDST results. In the 23 isolates with discordant results, the QMAP and DNA sequencing results completely matched.
Conclusions: The QMAP MDR/XDR assay can detect all known DNA mutations associated with drug resistance for both MDR- and XDR-MTB strains. It can be used for molecular diagnosis of MDR- and XDR-TB to rapidly initiate appropriate anti-TB drug therapy.
Keywords: Mycobacterium tuberculosis, Multidrug-resistant tuberculosis, Extensively drug-resistant tuberculosis, QuantaMatrix Multiplexed Assay Platform



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