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.
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.
Institute of Microbiology, Catholic University of the Sacred Heart, Rome, Italy michela.sali@rm.unicatt.it.
Michela
M
Sali
Institute of Microbiology, Catholic University of the Sacred Heart, Rome, Italy.
Flavio
F
De Maio
Section of Microbiology, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
Francesca
F
Caccuri
Section of Microbiology, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
Federica
F
Campilongo
Institute of Microbiology, Catholic University of the Sacred Heart, Rome, Italy.
Maurizio
M
Sanguinetti
Section of Microbiology, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
Simona
S
Fiorentini
Institute of Microbiology, Catholic University of the Sacred Heart, Rome, Italy.
Giovanni
http://orcid.org/0000-0003-0182-8267
G
Delogu
Section of Microbiology, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy.
Cinzia
C
Giagulli
D001431:Bacteriological Techniques / Q000379:methods*; D024901:Drug Resistance, Multiple, Bacterial; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D060885:Multiplex Polymerase Chain Reaction; D009161:Mycobacterium / Q000145:classification / Q000187:drug effects* / Q000235:genetics / Q000302:isolation & purification*; D011237:Predictive Value of Tests; D060888:Real-Time Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D013997:Time Factors; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis*