Ann Lab Med 2020; 40(2): 169-173  https://doi.org/10.3343/alm.2020.40.2.169
Diagnostic Performance of the GENEDIA MTB/NTM Detection Kit for Detecting Mycobacterium tuberculosis and Nontuberculous Mycobacteria With Sputum Specimens
Sunghwan Shin, M.D.1,*, In Young Yoo, M.D., Ph.D.1,*, Hyang Jin Shim, M.T.2, On Kyun Kang, M.T.1, Byung Woo Jhun, M.D., Ph.D.3, Won-Jung Koh, M.D., Ph.D.3, Hee Jae Huh, M.D., Ph.D.1, and Nam Yong Lee, M.D., Ph.D.1
1Department of Laboratory Medicine and Genetics, 2Samsung Biomedical Research Institute, and 3Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Corresponding author: Hee Jae Huh, M.D., Ph.D.
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea
Tel: +82-2-3410-1836 Fax: +82-2-3410-2719 E-mail: pmhhj77@gmail.com

Nam Yong Lee, M.D., Ph.D.
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea
Tel: +82-2-3410-2706 Fax: +82-2-3410-2719 E-mail: micro.lee@samsung.com

* These authors equally contributed to this study.
Received: June 4, 2019; Revised: July 29, 2019; Accepted: September 25, 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
The GENEDIA MTB/NTM Detection Kit (GENEDIA MTB/NTM; Green Cross Medical Science Corp., Chungbuk, Korea) is a multiplex real-time PCR assay used for differential identification of Mycobacterium tuberculosis complex (MTBC) and nontuberculous mycobacteria (NTM). While the importance of differential identification of MTB/NTM is recognized, there is limited data on the performance of GENEDIA MTB/NTM assay to date. A total of 687 consecutive sputum specimens were cultured and analyzed with the GENEDIA MTB/NTM and GENEDIA MTB assays. Nineteen specimens (2.8%) were MTBC-positive, and 69 (10.0%) were NTM-positive based on mycobacterial culture. All specimens showed concordant results for MTBC using both assays, with a kappa value of 1.00, overall sensitivity of 63.2% (12/19), and specificity of 100% (668/668). The overall NTM sensitivity and specificity were 23.2% (16/69) and 99.7% (616/618) for GENEDIA MTB/NTM. The association between NTM-positivity using GENEDIA MTB/NTM and the diagnosis of NTM pulmonary disease was not statistically significant. In conclusion, the two real-time PCR assays showed similar diagnostic performance for MTBC detection. However, the sensitivity for NTM detection was lower than that for MTBC detection.
Keywords: Mycobacterium tuberculosis complex, Nontuberculous mycobacteria, Performance, Detection, Real-time PCR, Mycobacterial culture



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