Evaluation of the Diagnostic Performance of the AdvanSure TB/NTM Real-Time PCR Kit for Detection of Mycobacteria

Background: The AdvanSure TB/NTM real-time PCR kit (AdvanSure) was newly developed in Korea to detect Mycobacterium tuberculosis and nontuberculous mycobacteria (NTM) utilizing a specific primer and TaqMan probe targeting the IS6110 and rpoB genes which are unique to these species. The purpose of the present study was to evaluate the clinical utility of AdvanSure by comparing the results of acid-fast staining, mycobacteria culture, COBAS Amplicor MTB PCR (Amplicor), and AdvanSure. Methods: A total of 182 specimens (105 respiratory and 77 nonrespiratory specimens) were obtained from 165 patients, and acid fast bacilli (AFB) staining, mycobacteria culture, and Amplicor were performed on all specimens. AdvanSure was also performed on the above specimens using the SLAN real-time PCR detection system. The sensitivity and specificity of AdvanSure were analyzed using AFB staining and culture. Results: Of the 182 specimens, M. tuberculosis was detected in 43 specimens and NTM was detected in 12 specimens according to PCR and/or culture. The sensitivity and specificity of the AdvanSure based on AFB culture were 97.3% (36/37) and 95.5% (127/ 133) in M. tuberculosis and 75.0% (9/12) and 100% (0/133) in NTM, respectively. Conclusion: AdvanSure could be useful for detecting M. tuberculosis and NTM in the clinical laboratory with high sensitivity and specificity. (Korean J Clin Microbiol 2011;14:55-59)