In our opinion, the implementation of the Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA, USA) since 2010 has revolutionised molecular diagnosis of (multidrug-resistant) tuberculosis. Xpert combines early diagnosis of tuberculosis with direct detection of rifampicin resistance, but the limitations of the assay are its suboptimal sensitivity and high rate of false positivity in low-prevalence settings. To overcome these limitations, the assay was re-engineered to increase diagnostic sensitivity and improve specificity in the detection of rifampicin resistance.

中文翻译：

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Xpert MTB / RIF Ultra的性能：生死攸关的问题

我们认为，自2010年以来实施Xpert MTB / RIF分析（美国加利福尼亚州森菲韦尔市的Cepheid），彻底改变了（耐多药）结核病的分子诊断方法。Xpert将结核病的早期诊断与对利福平耐药性的直接检测相结合，但该方法的局限性是其次优灵敏度和低患病率的假阳性率较高。为了克服这些局限性，对检测方法进行了重新设计，以提高诊断灵敏度并提高对利福平耐药性检测的特异性。