Diagnostic performance of the Anyplex MTB/NTM real-time PCR in detection of Mycobacterium tuberculosis complex and nontuberculous mycobacteria from pulmonary and extrapulmonary specimens

Accurate and rapid diagnosis of mycobacterial infections is significant for appropriate treatment. In this study, we retrospectively evaluated the performance of the Anyplex MTB/NTM real-time detection assay (Anyplex MTB/NTM) compared to mycobacterial culture in detecting Mycobacterium tuberculosis complex (MTBC) and nontuberculous mycobacteria (NTM) in 9,575 clinical specimens. For MTBC detection, the sensitivity, specificity, PPV, NPV, and percent agreement of the Anyplex MTB/NTM were 79.7%, 94.5%, 64.4%, 97.4%, and 92.9%, respectively. In pediatric patient (age ≤15) specimens, the Anyplex MTB/NTM demonstrated 84.8% sensitivity and 95.8% specificity. For NTM detection, the sensitivity, specificity, PPV, NPV, and percent agreement were 44.9%, 97.7%, 36.7%, 98.4%, and 96.2%, respectively. The sensitivity of the Anyplex MTB/NTM was enhanced in acid-fast bacilli (AFB) smear-positive specimens which was 97.7% and 80% for MTBC and NTM detection, respectively. The Anyplex MTB/NTM is a rapid tool for detection and differentiation of MTBC and NTM in clinical specimens.