Ann Lab Med.  2020 Mar;40(2):169-173. 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

• Shin S
• Yoo IY
• Shim HJ
• Kang OK
• Jhun BW
• Koh WJ
• Huh HJ
• Lee NY

• KMID: 2460915
• DOI: http://doi.org/10.3343/alm.2020.40.2.169

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.

Keyword

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

MeSH Terms

Chungcheongbuk-do
Diagnosis
Lung Diseases
Mycobacterium tuberculosis*
Mycobacterium*
Nontuberculous Mycobacteria*
Real-Time Polymerase Chain Reaction
Sensitivity and Specificity
Sputum*

Reference

1. World Health Organization. Global tuberculosis report 2018. Updated on March 2019. https://www.who.int/tb/publications/global_report/en/.

2. Honda JR, Virdi R, Chan ED. Global environmental nontuberculous mycobacteria and their contemporaneous man-made and natural niches. Front Microbiol. 2018; 9:2029. PMID: 30214436.

3. Jeon D. Infection source and epidemiology of nontuberculous mycobacterial lung disease. Tuberc Respir Dis (Seoul). 2019; 82:94–101. PMID: 30302953.

4. Lee H, Myung W, Koh WJ, Moon SM, Jhun BW. Epidemiology of nontuberculous mycobacterial infection, South Korea, 2007-2016. Emerg Infect Dis. 2019; 25:569–572. PMID: 30789139.

5. Ryu YJ, Koh WJ, Daley CL. Diagnosis and treatment of nontuberculous mycobacterial lung disease: clinicians' perspectives. Tuberc Respir Dis (Seoul). 2016; 79:74–84. PMID: 27066084.

6. van Ingen J. Microbiological diagnosis of nontuberculous mycobacterial pulmonary disease. Clin Chest Med. 2015; 36:43–54. PMID: 25676518.

7. Huh HJ, Kim SY, Jhun BW, Shin SJ, Koh WJ. Recent advances in molecular diagnostics and understanding mechanisms of drug resistance in nontuberculous mycobacterial diseases. Infect Genet Evol. 2019; 72:169–182. PMID: 30315892.

8. Jung YJ, Kim JY, Song DJ, Koh WJ, Huh HJ, Ki CS, et al. Evaluation of three real-time PCR assays for differential identification of Mycobacterium tuberculosis complex and nontuberculous mycobacteria species in liquid culture media. Diagn Microbiol Infect Dis. 2016; 85:186–191. PMID: 27105774.

9. Wang HY, Kim H, Kim S, Kim DK, Cho SN, Lee H. Performance of a real-time PCR assay for the rapid identification of Mycobacterium species. J Microbiol. 2015; 53:38–46. PMID: 25557479.

10. Sali M, De Maio F, Caccuri F, Campilongo F, Sanguinetti M, Fiorentini S, et al. Multicenter evaluation of Anyplex Plus MTB/NTM MDR-TB assay for rapid detection of Mycobacterium tuberculosis complex and multidrug-resistant isolates in pulmonary and extrapulmonary specimens. J Clin Microbiol. 2016; 54:59–63. PMID: 26491178.

11. Choe W, Kim E, Park SY, Chae JD. Performance evaluation of Anyplex plus MTB/NTM and AdvanSure TB/NTM for the detection of Mycobacterium tuberculosis and nontuberculous mycobacteria. Ann Clin Microbiol. 2015; 18:44–51.

12. Perry MD, White PL, Ruddy M. Potential for use of the Seegene Anyplex MTB/NTM real-time detection assay in a regional reference laboratory. J Clin Microbiol. 2014; 52:1708–1710. PMID: 24554748.

13. Huh HJ, Kwon HJ, Ki CS, Lee NY. Comparison of the Genedia MTB detection kit and the Cobas TaqMan MTB assay for detection of Mycobacterium tuberculosis in respiratory specimens. J Clin Microbiol. 2015; 53:1012–1014. PMID: 25568443.

14. CLSI. Laboratory detection and identification of mycobacteria; approved guideline. CLSI M48-A. Wayne, PA: Clinical and Laboratory Standards Institute;2008.

15. Diagnostic standards and classification of tuberculosis in adults and children. This official statement of the American Thoracic Society and the Centers for Disease Control and Prevention was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000; 161:1376–1395. PMID: 10764337.

16. Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007; 175:367–416. PMID: 17277290.

17. Horita N, Yamamoto M, Sato T, Tsukahara T, Nagakura H, Tashiro K, et al. Sensitivity and specificity of Cobas TaqMan MTB real-time polymerase chain reaction for culture-proven Mycobacterium tuberculosis: meta-analysis of 26999 specimens from 17 Studies. Sci Rep. 2015; 5:18113. PMID: 26648113.

18. Kim JU, Ryu DS, Cha CH, Park SH. Paradigm for diagnosing mycobacterial disease: direct detection and differentiation of Mycobacterium tuberculosis complex and non-tuberculous mycobacteria in clinical specimens using multiplex real-time PCR. J Clin Pathol. 2018; 71:774–780. PMID: 29559518.