The Xpert MTB/RIF assay (Xpert) is a molecular assay used for direct detection of Mycobacterium tuberculosis (MTB) in clinical specimens. In this study, we aimed to assess the accuracy of the Xpert assay for the diagnosis of tuberculosis (TB) in TB suspected patients from the northern region of Iran. The obtained results were compared with the culture method. The sputum specimens were examined using the Xpert assay, smear microscopy, and solid culture media as a reference diagnostic tool. Among 293 presumptive TB cases, 92 (31.4%) were positive according to the culture method. The Xpert method detected 88 (95.7%) cases that were positive according to the culture method, compared with 78 (84.8%) positive cases according to smear microscopy. The overall sensitivity and specificity of the Xpert method for TB diagnosis were 95.7% and 99%, respectively. Also, the sensitivity and specificity for smear microscopy were 84.8% and 97.5%, respectively. The Xpert assay showed high overall sensitivity and specificity; thus, it can be effectively used for the early and accurate diagnosis of MTB in TB endemic areas. In addition, the agreement between semi‐quantitative results of Xpert and smear microscopy assays could be helpful in evaluating transmission potential in TB patients.

中文翻译：

---

评估Xpert MTB / RIF测试在中等结核病负担地区诊断结核病的准确性

Xpert MTB / RIF测定法（Xpert）是一种用于直接检测结核分枝杆菌的分子测定法（MTB）在临床标本中。在这项研究中，我们旨在评估Xpert测定法在伊朗北部地区可疑结核病患者中诊断结核病（TB）的准确性。将所得结果与培养方法进行比较。使用Xpert分析，涂片显微镜检查和固体培养基作为参考诊断工具检查痰标本。根据培养方法，在293例推测性结核病例中，有92例（31.4％）为阳性。Xpert法检测到88例（95.7％）阳性病例，而涂片显微镜检查则为78例（84.8％）阳性。Xpert方法对结核病诊断的总体敏感性和特异性分别为95.7％和99％。另外，涂片显微镜检查的敏感性和特异性分别为84.8％和97.5％。Xpert分析显示出较高的总体敏感性和特异性；因此，它可以有效地用于结核病流行地区的MTB的早期和准确诊断。此外，Xpert的半定量结果与涂片显微镜检测之间的一致性可能有助于评估结核病患者的传播潜力。