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应用Xpert MTB/RIF对脊柱结核临床标本行结核分枝杆菌与利福平耐药性检测的验证性研究 被引量:43

Assessment of the Xpert MTB/RIF assay for the detection of M. tuberculosis and rifampicin resistance in spinal tubercu- losis specimens. A retrospective validation study
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摘要 目的采用XpertMTB/RIF系统对系列脊柱结核临床标本进行结核分枝杆菌检出与利福平耐药基因rpoB突变检测,初步验证该项技术的可行性与准确性。方法自全军结核病研究所标本库中筛选140份脊柱结核临床标本,对标本行前处理后采用XpertMTB/RIF系统进行结核分枝杆菌与利福平耐药基因rpoB的突变检测,以培养结果及表型药敏试验为金标准,判断XpertMTB/RIF检测的敏感度、特异度、95%置信区间及检测耗时。结果对临床确诊为脊柱结核的140份临床标本,XpertMTB/RIF系统的结核分枝杆菌阳性检出率为63.57%(89/140);在64份培养阳性标本中,XpertMTB/RIF检测结核分枝杆菌的敏感度为98.44%(63/64);在76份培养阴性标本中,XpertMTB/RIF检测结核分枝杆菌的敏感度为34.21%(26/76)。以表型药敏试验为金标准,采用XpertMTB/RIF系统行利福平耐药性检测的敏感度为93.33%(28/30),特异度为94.12%(32/34)。XpertMTB/RIF系统平均检测耗时为2.1h(1.8~2.6h)。结论XpertMTB/RIF是一种简便、快速、准确,且能够同时对脊柱结核临床标本行结核分枝杆菌检测与利福平耐药性检测的分子检测技术,具有潜在的临床应用价值。 Objective To assess the performance of the Xpert MTB/RIF system in the detection of tuberculosis and its ri- fampicin resistance form in spinal tuberculosis specimens. Methods From June 2009 to December 2012, 140 spinal tuberculo- sis specimens selected from the tissue bank of The 309th Hospital of the PLA were enrolled into this study. Specimens were pro- processed and subjected to M. tuberculosis and rifampicin resistance detection by the Xpert MTB/RIF, and results were compared with those obtained from the M. tuberculosis cultivation and absolute concentration drug susceptibility testing to tell the sensitivity, specificity, 95% confidence interval and detection time-consuming of Xpert MTB/RIF. Results The Xpert MTB/RIF system achieved 63.57% (89/140) sensitivity for the correct detection of M. tuberculosis from the 140 specimens with the diagnosis of spi- nal tuberculosis clinically and pathologically. The Xpert MTB/RIF system achieved 98.44% (53/64) sensitivity for the detection of M. tuberculosis from specimens tested positive for spinal tuberculosis through culture. In addition, twenty-six additional patients (34.21%) were detected by the Xpert MTB/RIF to be positive for M. tuberculosis among seventy-six spinal tuberculosis patients who were culture negative. Moreover, the Xpert MTB/RIF had a sensitivity of 93.33% (28/30) and a specificity of 94.12% (32/34) for rifampicin resistance detection. The mean run time of Xpert MTB/RIF was 2.1 hours (range, 1.8-2.6 hours). Conclusion The Xpert MTB/RIF is a rapid, feasible, convenient and accurate tool for the detection of M. tuberculosis and for directly detecting ri- fampicin resistance from spinal tuberculosis specimens.
出处 《中华骨科杂志》 CAS CSCD 北大核心 2014年第2期211-215,共5页 Chinese Journal of Orthopaedics
关键词 结核 脊柱 广泛耐药结核 微生物敏感性试验 多重聚合酶链式反应 利福平 Tuberculosis, Spinal Extensively drug-resistant tuberculosis Microbial sensitivity tests Multiplex poly-merase chain reaction Rifampin
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