PD Hinduja National Hospital and Medical Research Centre, Mahim, Mumbai, India.
J Clin Microbiol. 2011 Jul;49(7):2540-5. doi: 10.1128/JCM.02319-10. Epub 2011 May 18.
Approximately 10 to 15% of tuberculosis (TB) cases in India are estimated to have extrapulmonary disease, and due to a lack of diagnostic means, they often remain untreated. The early detection of Mycobacterium tuberculosis and multidrug resistance is a priority in TB diagnosis to improve the successful treatment rate of TB and reduce transmission. The Xpert MTB/RIF (Xpert) test, recently endorsed by the World Health Organization for the detection of pulmonary TB, was evaluated to test its utility in 547 patients with suspected extrapulmonary tuberculosis. Five hundred forty-seven extrapulmonary specimens were split and processed simultaneously for both culture (solid and liquid) and Xpert testing. For culture, the sensitivity was low, 53% (150/283 specimens). Xpert sensitivity and specificity results were assessed in comparison to a composite reference standard made up of smear and culture results and clinical, radiological, and histological findings. The sensitivity of the Xpert assay was 81% (228/283 specimens) (64% [89/138] for smear-negative cases and 96% [139/145] for smear-positive cases), with a specificity of 99.6%. The sensitivity was found to be high for the majority of specimen types (63 to 100%) except for cerebrospinal fluid, the sensitivity of which was 29% (2/7 specimens). The Xpert test correctly identified 98% of phenotypic rifampin (RIF)-resistant cases and 94% of phenotypic RIF-susceptible cases. Sequencing of the 6 discrepant samples resolved 3 of them, resulting in an increased specificity of 98%. In conclusion, the results of this study suggest that the Xpert test also shows good potential for the diagnosis of extrapulmonary TB and that its ease of use makes it applicable for countries where TB is endemic.
据估计,印度约有 10%至 15%的结核病(TB)病例为肺外疾病,由于缺乏诊断手段,这些病例往往得不到治疗。早期发现结核分枝杆菌和耐多药结核分枝杆菌是结核病诊断的重点,以提高结核病治疗成功率并降低传播率。Xpert MTB/RIF(Xpert)检测最近被世界卫生组织批准用于检测肺结核,该检测在 547 名疑似肺外结核患者中进行了评估,以测试其在该人群中的应用。将 547 份肺外标本分为两部分,同时进行培养(固体和液体)和 Xpert 检测。培养的敏感性较低,为 53%(150/283 份标本)。Xpert 检测的敏感性和特异性结果与由涂片和培养结果以及临床、影像学和组织学发现组成的综合参考标准进行了比较。Xpert 检测的敏感性为 81%(228/283 份标本)(涂片阴性病例为 64%[89/138],涂片阳性病例为 96%[139/145]),特异性为 99.6%。除脑脊液外,大多数标本类型的敏感性均较高(63%至 100%),脑脊液的敏感性为 29%(7 份标本中的 2 份)。Xpert 检测正确识别了 98%的表型利福平(RIF)耐药病例和 94%的表型 RIF 敏感病例。对 6 个不一致样本进行测序解决了其中的 3 个,特异性提高到 98%。总之,本研究结果表明,Xpert 检测也显示出在诊断肺外结核病方面具有良好的潜力,并且其易于使用使其适用于结核病流行的国家。