Performance Evaluation of Anyplex plus MTB/NTM and AdvanSure TB/NTM for the Detection of Mycobacterium tuberculosis and Nontuberculous Mycobacteria

Background: Polymerase chain reaction (PCR) methods from direct specimen are widely used for the rapid and accurate detection of mycobacteria infection. In this study, we evaluated two domestically developed detection kits for Mycobacterium tuberculosis (MTB) and nontuberculous mycobacteria (NTM) using real-time PCR. Methods: A total of 348 samples from patients with suspected tuberculosis were tested with real-time PCR over seven months. We performed real-time PCR using the recently developed Anyplex plus MTB/NTM Detection kit (Seegene) with the CFX 96TM Realtime PCR System (Bio-Rad Laboratories) and the conventional AdvanSure TB/NTM real-time PCR kit (LG Life Sciences) with the SLAN Real-time PCR detection system (LG Life Sciences) to evaluate their performance for detecting MTB and NTM. Results: The two real-time PCR systems showed 96.8% concordance rate for MTB-positive, NTM-positive, and negative results. Based on culture results, the sensitivity and specificity for the detection of MTB using PCR were 71.0% and 94.9% for Anyplex plus, and 78.1% and 93.9% for AdvanSure, respectively. For the detection of NTM, the sensitivity and specificity were 33.3% and 98.4% for Anyplex plus, and 51.7% and 97.9% for AdvanSure. Both PCR systems showed high MTB positive results in bronchial washing and sputum samples. Conclusion: In detecting MTB and NTM, Anyplex plus MTB/NTM (Seegene) and AdvanSure TB/NTM real-time PCR (LG Life Sciences) showed high concordance rate with each other in all samples. Therefore both detection kits can be used as rapid and reliable detection tool for MTB. (Ann Clin Microbiol 2015;18:44 -51)