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首页> 外文期刊>Journal of Clinical Microbiology >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
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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

机译：多中心Anyplex Plus MTB / NTM MDR-TB分析的多中心评估，可快速检测肺和肺外标本中的结核分枝杆菌复合物和耐多药分离株

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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.
机译：结核病（TB）的快速诊断和耐药结核分枝杆菌菌株的检测对于成功的公共卫生干预至关重要。因此，结核病诊断需要可快速诊断结核分枝杆菌和临床样品中耐药性的诊断工具。在这里，我们进行了一项多中心研究，以评估Seegene Anyplex MTB / NTM MDR-TB分析（一种基于多重实时PCR系统的新分子方法）的性能，以检测结核分枝杆菌复合体（MTBC），非结核分枝杆菌（ NTM），以及耐药性的遗传决定因素。总共将755个样本（534个肺样本和221个肺外样本）的结果与涂片和培养的结果进行了比较。对于肺部标本，Anyplex试验和抗酸杆菌涂片试验的灵敏度分别为86.4％和75.0％，特异性为99％和99.4％。对于肺外标本，Anyplex试验和抗酸杆菌涂片试验的灵敏度分别为83.3％和50.0％，两者的特异性均为100％。肺标本的Anyplex检测的阴性和阳性预测值分别为97％和100％，肺外标本的阴性和阳性预测值为84.6％和100％。用于检测肺和肺外标本的MTBC菌株中异烟肼耐药性的Anyplex检测的灵敏度分别为83.3％和50％，而两种标本的特异性均为100％。这些结果表明，Anyplex MTB / NTM MDR-TB测定法是诊断肺结核和肺外结核以及检测异烟肼耐药性的有效而快速的方法。

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