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

• Published in: Annals of laboratory medicine Vol. 40; no. 2; pp. 169 - 173
• Main Authors: Shin, Sunghwan, Yoo, In Young, Shim, Hyang Jin, Kang, On Kyun, Jhun, Byung Woo, Koh, Won Jung, Huh, Hee Jae, Lee, Nam Yong
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Society for Laboratory Medicine 01.03.2020; 대한진단검사의학회
• Subjects: Brief Communication; DNA, Bacterial - analysis; Humans; Multiplex Polymerase Chain Reaction; Mycobacterium Infections, Nontuberculous - diagnosis; Mycobacterium Infections, Nontuberculous - microbiology; Mycobacterium tuberculosis - genetics; Mycobacterium tuberculosis - isolation & purification; Nontuberculous Mycobacteria - genetics; Nontuberculous Mycobacteria - isolation & purification; Reagent Kits, Diagnostic; Sensitivity and Specificity; Sputum - microbiology; Tuberculosis - diagnosis; Tuberculosis - microbiology; 병리학; Mycobacterial culture; Mycobacterium tuberculosis complex; Real-time PCR; Detection; Performance; Nontuberculous mycobacteria
• ISSN: 2234-3806; 2234-3814
• DOI: 10.3343/alm.2020.40.2.169

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 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.