Clinical validation of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis
Clinical validation of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis
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DOI：
10.1183/09031936.00176311
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发表时间：
2012-08-01
影响因子：
24.3
通讯作者：
Cirillo, Daniela M.
中科院分区：
文献类型：
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作者：
Tortoli, Enrico;Russo, Cristina;Cirillo, Daniela M.
肺外结核（EPTB）占结核病（TB）病例的20%以上。Xpert MTB/RIF（Xpert）（Cepheid，桑尼维尔，CA，USA）是一种全自动扩增系统，最近报告了其在高度流行国家肺结核诊断中的出色结果。我们的目的是评估Xpert系统在低发病率环境下诊断EPTB的性能。（1，476，对应于1，068名患者），包括儿童（494）和成人样本。我们发现，与由结核病培养和临床诊断组合组成的参考标准相比，Xpert的总体敏感性和特异性分别为81.3%和99.8%，而显微镜检查的敏感性为48%。对于活检、尿液、脓液和脑脊液，灵敏度超过85%，而对于胃抽吸物，灵敏度略低于80%。相比之下，空腔积液的发生率低于50%。在儿科标本中也获得了高灵敏度和特异性（分别为86.9%和99.7%）。尽管培养在EPTB的微生物诊断中仍然起着核心作用，但Xpert在快速诊断疾病方面的灵敏度使其成为比涂片镜检更好的选择。排除这种疾病的能力仍然不理想。
Extrapulmonary tuberculosis (EPTB) accounts for more than 20% of tuberculosis (TB) cases. Xpert MTB/RIF (Xpert) (Cepheid, Sunnyvale, CA, USA) is a fully automated amplification system, for which excellent results in the diagnosis of pulmonary TB in highly endemic countries have been recently reported. We aimed to assess the performance of the Xpert system in diagnosing EPTB in a low incidence setting.We investigated with Xpert a large number of consecutive extrapulmonary clinical specimens (1,476, corresponding to 1,068 patients) including both paediatric (494) and adult samples.We found, in comparison with a reference standard consisting of combination of culture and clinical diagnosis of TB, an overall sensitivity and specificity of 81.3% and 99.8% for Xpert, while the sensitivity of microscopy was 48%. For biopsies, urines, pus and cerebrospinal fluids the sensitivity exceeded 85%, while it was slightly under 80% for gastric aspirates. It was, in contrast, lower than 50% for cavitary fluids. High sensitivity and specificity (86.9% and 99.7%, respectively) were also obtained for paediatric specimens.Although the role of culture remains central in the microbiological diagnosis of EPTB, the sensitivity of Xpert in rapidly diagnosing the disease makes it a much better choice compared to smear microscopy. The ability to rule out the disease still remains suboptimal.