The rapid diagnosis of tuberculosis (TB) and detection of drug-resistant Mycobacterium tuberculosis (Mtb) strains is a key prerequisite for successful public health interventions. Therefore, TB diagnosis requires the availability of diagnostic tools that allow the rapid detection of Mtb and drug resistances 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 multiplex real-time PCR system, for detecting Mycobacterium tuberculosis Complex (MTBC), non-tuberculous mycobacteria (NTM) and genetic determinants of drug resistance. In total, the results of 755 samples, 534 respiratory and 221 extra-pulmonary, were compared with smears and cultures. For pulmonary specimens, the sensitivities of Anyplex assay and acid-fast smear were 86.4% and 75.0%, and the specificities 99% and 99.4%, respectively. For extra-pulmonary specimens, the sensitivities of Anyplex assay and acid-fast smear were 83.3% and 50.0%, respectively, and the specificities of both were 100%. Negative predictive value and positive predictive value of Anyplex assay for pulmonary specimens were 97% and 100%, for extra-pulmonary specimens 84.6% and 100%, respectively.The sensitivity of the Anyplex assay in detecting isoniazid resistance in MTBC strains from pulmonary and extra-pulmonary specimens were 83.3% and 50%, respectively, while the specificity was 100% for both specimens types.These results demonstrate that Anyplex MTB/NTM MDR-TB assay is an efficient and rapid method for diagnosis of pulmonary and extra-pulmonary TB, and detection of isoniazid resistance.

Multicenter Evaluation of the Anyplex™ Plus MTB/NTM MDR-TB Assay for Rapid Detection of Mycobacterium tuberculosis Complex and Multidrug-resistant Isolates in Pulmonary and Extrapulmonary Specimens

CACCURI, Francesca;CAMPILONGO, Federica;FIORENTINI, Simona;GIAGULLI, Cinzia
2016-01-01

Abstract

The rapid diagnosis of tuberculosis (TB) and detection of drug-resistant Mycobacterium tuberculosis (Mtb) strains is a key prerequisite for successful public health interventions. Therefore, TB diagnosis requires the availability of diagnostic tools that allow the rapid detection of Mtb and drug resistances 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 multiplex real-time PCR system, for detecting Mycobacterium tuberculosis Complex (MTBC), non-tuberculous mycobacteria (NTM) and genetic determinants of drug resistance. In total, the results of 755 samples, 534 respiratory and 221 extra-pulmonary, were compared with smears and cultures. For pulmonary specimens, the sensitivities of Anyplex assay and acid-fast smear were 86.4% and 75.0%, and the specificities 99% and 99.4%, respectively. For extra-pulmonary specimens, the sensitivities of Anyplex assay and acid-fast smear were 83.3% and 50.0%, respectively, and the specificities of both were 100%. Negative predictive value and positive predictive value of Anyplex assay for pulmonary specimens were 97% and 100%, for extra-pulmonary specimens 84.6% and 100%, respectively.The sensitivity of the Anyplex assay in detecting isoniazid resistance in MTBC strains from pulmonary and extra-pulmonary specimens were 83.3% and 50%, respectively, while the specificity was 100% for both specimens types.These results demonstrate that Anyplex MTB/NTM MDR-TB assay is an efficient and rapid method for diagnosis of pulmonary and extra-pulmonary TB, and detection of isoniazid resistance.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11379/466707
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