Diagnostic Performance of the GENEDIA MTB/NTM Detection Kit for Detecting Mycobacterium tuberculosis and Nontuberculous Mycobacteria with Sputum Specimens

Sunghwan Shin; In Young Yoo; Hyang Jin Shim; On Kyun Kang; Byung Woo Jhun; Won Jung Koh; Hee Jae Huh; Nam Yong Lee

doi: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
, In Young Yoo
, Hyang Jin Shim
, On Kyun Kang
, Byung Woo Jhun
, Won Jung Koh
, Hee Jae Huh
, Nam Yong Lee

Department of Laboratory Medicine

Samsung Medical Center, Sungkyunkwan university

Research output: Contribution to journal › Article › peer-review

14 Scopus citations

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.

Original language	English
Pages (from-to)	169-173
Number of pages	5
Journal	Annals of Laboratory Medicine
Volume	40
Issue number	2
DOIs	https://doi.org/10.3343/alm.2020.40.2.169
State	Published - 2020

Bibliographical note

Publisher Copyright:
© Korean Society for Laboratory Medicine 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.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Detection
Mycobacterial culture
Mycobacterium tuberculosis complex
Nontuberculous mycobacteria
Performance
Real-time PCR

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10.3343/alm.2020.40.2.169

Cite this

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title = "Diagnostic Performance of the GENEDIA MTB/NTM Detection Kit for Detecting Mycobacterium tuberculosis and Nontuberculous Mycobacteria with Sputum Specimens",

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 = "Detection, Mycobacterial culture, Mycobacterium tuberculosis complex, Nontuberculous mycobacteria, Performance, Real-time PCR",

author = "Sunghwan Shin and Yoo, \{In Young\} and Shim, \{Hyang Jin\} and Kang, \{On Kyun\} and Jhun, \{Byung Woo\} and Koh, \{Won Jung\} and Huh, \{Hee Jae\} and Lee, \{Nam Yong\}",

note = "Publisher Copyright: {\textcopyright} Korean Society for Laboratory Medicine 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.",

year = "2020",

doi = "10.3343/alm.2020.40.2.169",

language = "English",

volume = "40",

pages = "169--173",

journal = "Annals of Laboratory Medicine",

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publisher = "Korean Society for Laboratory Medicine",

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TY - JOUR

T1 - Diagnostic Performance of the GENEDIA MTB/NTM Detection Kit for Detecting Mycobacterium tuberculosis and Nontuberculous Mycobacteria with Sputum Specimens

AU - Shin, Sunghwan

AU - Yoo, In Young

AU - Shim, Hyang Jin

AU - Kang, On Kyun

AU - Jhun, Byung Woo

AU - Koh, Won Jung

AU - Huh, Hee Jae

AU - Lee, Nam Yong

N1 - Publisher Copyright: © Korean Society for Laboratory Medicine 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.

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

KW - Detection

KW - Mycobacterial culture

KW - Mycobacterium tuberculosis complex

KW - Nontuberculous mycobacteria

KW - Performance

KW - Real-time PCR

UR - https://www.scopus.com/pages/publications/85074060268

U2 - 10.3343/alm.2020.40.2.169

DO - 10.3343/alm.2020.40.2.169

M3 - Article

C2 - 31650734

AN - SCOPUS:85074060268

SN - 2234-3806

VL - 40

SP - 169

EP - 173

JO - Annals of Laboratory Medicine

JF - Annals of Laboratory Medicine

IS - 2

ER -

Diagnostic Performance of the GENEDIA MTB/NTM Detection Kit for Detecting Mycobacterium tuberculosis and Nontuberculous Mycobacteria with Sputum Specimens

Abstract

Bibliographical note

UN SDGs

Keywords

Access to Document

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