Anyplex Multiplex PCR Validated for Rapid TB Detection and Isoniazid Resistance in Pulmonary and Extrapulmonary Specimens
A multicenter evaluation of the Seegene Anyplex MTB/NTM MDR-TB assay across 755 clinical samples demonstrated 86.4% sensitivity in pulmonary and 83.3% in extrapulmonary specimens for M. tuberculosis detection, substantially outperforming smear microscopy (75% and 50%, respectively). The assay simultaneously detects nontuberculous mycobacteria and genetic determinants of isoniazid resistance with 100% specificity. This multiplex real-time PCR platform enables laboratories to deliver rapid, comprehensive mycobacterial diagnostics from a single test.
The original study
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.
- Authors
- Sali M, De Maio F, Caccuri F, Campilongo F, Sanguinetti M, Fiorentini S, et al.
- Journal
- Journal of clinical microbiology
- Type
- Evaluation Study, Journal Article, Multicenter Study
- PMID
- 26491178
Original abstract
The rapid diagnosis of tuberculosis (TB) and the detection of drug-resistant Mycobacterium tuberculosis strains are critical for successful public health interventions. Therefore, TB diagnosis requires the availability of diagnostic tools that allow the rapid detection of M. tuberculosis and drug resistance in clinical samples. Here, we performed a multicenter study to evaluate the performance of the Seegene Anyplex MTB/NTM MDR-TB assay, a new molecular method based on a multiplex real-time PCR system, for detection of Mycobacterium tuberculosis complex (MTBC), nontuberculous mycobacteria (NTM), and genetic determinants of drug resistance. In total, the results for 755 samples (534 pulmonary and 221 extrapulmonary samples) were compared with the results of smears and cultures. For pulmonary specimens, the sensitivities of the Anyplex assay and acid-fast bacillus smear testing were 86.4% and 75.0%, respectively, and the specificities were 99% and 99.4%. For extrapulmonary specimens, the sensitivities of the Anyplex assay and acid-fast bacillus smear testing were 83.3% and 50.0%, respectively, and the specificities of both were 100%. The negative and positive predictive values of the Anyplex assay for pulmonary specimens were 97% and 100%, respectively, and those for extrapulmonary specimens were 84.6% and 100%. The sensitivities of the Anyplex assay for detecting isoniazid resistance in MTBC strains from pulmonary and extrapulmonary specimens were 83.3% and 50%, respectively, while the specificities were 100% for both specimen types. These results demonstrate that the Anyplex MTB/NTM MDR-TB assay is an efficient and rapid method for the diagnosis of pulmonary and extrapulmonary TB and the detection of isoniazid resistance.