Gene Xpert-MTB/RIF检测法在结核病诊断中的意义
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摘要
目的探讨Gene Xpert-MTB/RIF检测结核分枝杆菌及利福平耐药性在结核病诊断中的作用。方法收集2017年8月至2017年12月在我院住院的202例结核病患者,对其痰标本分别行痰涂片、痰培养、比例法体外药敏试验和Gene Xpert-MTB/RIF法检测,并对Xpert-MTB/RIF检测结果进行分析。结果 Xpert MTB/RIF阳性率及痰培养阳性率明显高于痰涂片,差异有统计学意义;而Xpert MTB/RIF阳性率与痰培养阳性率比较,差异无统计学意义;以痰培养为金标准,Xpert MTB/RIF检测结核分枝杆菌及利福平耐药的敏感度分别为75.9%和66.7%,特异度分别为82.8%和100.0%。Xpert MTB/RIF及传统比例法检测利福平耐药一致性好。结论 Xpert检测与传统方法相比快捷,并具有更高灵敏度及特异度,可为临床诊断、选择耐药结核的治疗方案提供参考。
Objective To investigate the role of Gene Xpert-MTB/RIF detection of Mycobacterium tuberculosis and its rifampicin resistance in the diagnosis of tuberculosis. Methods We collected sputum samples in 202 TB patients in our hospital from August 2017 to December 2017,and detected the sputum samples by acid fast sputum smear staining,sputum culture,in vitro drug sensitivity ratio test and Gene Xpert-MTB/RIF method,and the results of Gene Xpert-MTB/RIF detection were analyzed. Results The positive rate of Xpert MTB/RIF detectionwassignificantlyhigherthanthatofsputumsmear,andthedifferencewasstatisticallysignificant(P <0.05);for the comparison of positive rates of Xpert-MTB/RIF and sputum culture,no statistically significant difference was found(P > 0.05). Taking the sputum culture as the gold standard,the sensitivity and specificity of Xpert MTB/RIF detection were 75.9% and 82.8%,respectively,and the sensitivity and the specificity of Xpert MTB/RIF detection for rifampicin resistance were 66.7% and 100%,respectively. The Xpert MTB/RIF and the traditional in vitro drug sensitivity ratio test had good consistency in detecting rifampicin resistance. Conclusion Compared with traditional tests,Xpert detection is quicker,with higher sensitivity and higher specificity. It can provide references for clinical diagnosis,selection and adjustment of therapeutic regimens for drug-resistant tuberculosis,and has broad application prospects.
Objective To investigate the role of Gene Xpert-MTB/RIF detection of Mycobacterium tuberculosis and its rifampicin resistance in the diagnosis of tuberculosis. Methods We collected sputum samples in 202 TB patients in our hospital from August 2017 to December 2017,and detected the sputum samples by acid fast sputum smear staining,sputum culture,in vitro drug sensitivity ratio test and Gene Xpert-MTB/RIF method,and the results of Gene Xpert-MTB/RIF detection were analyzed. Results The positive rate of Xpert MTB/RIF detectionwassignificantlyhigherthanthatofsputumsmear,andthedifferencewasstatisticallysignificant(P <0.05);for the comparison of positive rates of Xpert-MTB/RIF and sputum culture,no statistically significant difference was found(P > 0.05). Taking the sputum culture as the gold standard,the sensitivity and specificity of Xpert MTB/RIF detection were 75.9% and 82.8%,respectively,and the sensitivity and the specificity of Xpert MTB/RIF detection for rifampicin resistance were 66.7% and 100%,respectively. The Xpert MTB/RIF and the traditional in vitro drug sensitivity ratio test had good consistency in detecting rifampicin resistance. Conclusion Compared with traditional tests,Xpert detection is quicker,with higher sensitivity and higher specificity. It can provide references for clinical diagnosis,selection and adjustment of therapeutic regimens for drug-resistant tuberculosis,and has broad application prospects.
引文
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[14]World Health Organization.Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children[R].Geneva:WHO,2014.
[15]THERON G,ZIJENAH L,CHANDA D,et al.Feasibility,accuracy,and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa:a multicentre,randomised,controlled trial[J].Lancent,2014,383(9915):424-435.
[16]DETJEN A K,DINARDO A R,LEYDEN J,et al.Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in children:a systematic review and meta-analysis[J].Lancet Respir Med,2015,3(6):451-461.
[17]MOUSSA H S H,BAYOUMI F S,ALI A M.Evaluation of GeneXpert MTB/RIF assay for direct diagnosis of pulmonary tuberculosis[J].Saudi Med J,2016,37(10):1076-1081.
[18]梅枚,罗雁,刘会领.Xpert MTB/RIF检测在肠结核快速诊断中的应用观察[J].实用医学杂志,2016,32(18):3073-3075.
[19]RABNA P,RAMOS J,PONCE G,et al.Direct detection by the Xpert MTB/RIF assay and characterization of multi and poly drug-resistant tuberculosis in Guinea-Bissau,West Africa[J].PLoS One,2015,10(5):e0127536.
[20]GUENAOUI K,HARIR N,OUARDI A,et al.Use of gene Xpert Mycobacterium tuberculosis/rifampicin for rapid detection of rifampicin resistant Mycobacterium tuberculosis strains of clinically suspected multi-drug resistance tuberculosis cases[J].Ann Transl Med,2016,4(9):168.
[2]World Health Organization.Global tuberculosis report 2016[R].Geneva:WHO,2016.
[3]World Health Organization.Use of high burden country lists for TB by WHO in the post 2015[R].Geneva:WHO,2015.
[4]MULDER C,MGODE G F,ELLIS H,et al.Accuracy of giant African pouched rats for diagnosing tuberculosis:comparison with culture and Xpert?MTB/RIF[J].Int J Tuberc Lung Dis,2017,21(11):1127-1133.
[5]CAMPOS L C,ROCHA M V,WILLERS D M,et al.Characteristics of patients with smear-negative pulmonary tuberculosis(TB)in a region with high TB and HIV prevalence[J].PLoS One,2016,11(1):e0147933.
[6]尹青琴,申阿东.XpertMtb/RIF试验在结核病诊断中的研究现状[J].中华结核和呼吸杂志,2012,35(5):363-365.
[7]赵冰,欧喜超,夏辉,等.XpertMtb/RIF检测技术在结核病诊断中的应用评价[J].中国防痨杂志,2014,36(6):462-466.
[8]AIA P,KAL M,LAVU E,et al.The burden of drug-resistant tuberculosis in Papua New Guinea:rusults of a large populationbased survey[J].PLoS One,2016,11(3):e0149806.
[9]MEFTAHI N,NAMOUCHI A,MHENNI B,et al.Evidence for the critical role of a secondary site rpoB mutation in the compensatory evolution and successful transmission of an MDR tuberculosis outbreak strain[J].J Antimicrob Chemother,2016,71(2):324-332.
[10]XU G,WANG J,GUO Y,et al.Analysis of the molecular evolution of the Mycobacterium tuberculosis drug-resistant gene rpoBin Aisa using a Bayesian evolutionary method[J].Clin Lab,2015,61(8):1017-1025.
[11]IRAM S,ZEENAT A,HUSSAIN S,et al.Rapid diagnosis of tuberculosis using Xpert MTB/RIF assay-report from a developing country[J].Pak J Med Sci,2015,31(1):105-110.
[12]BODMER T,STROHLE A.Diagnosing pulmonary tuberculosis with the Xpert MTB/RIF test[J].J Vis Exp,2012,(62):e3547.
[13]LAWM S D,NICOL M P.Xpert MTB/RIF assay:development,evaluation and implementation of a new rapid molecular diagnostic for tuberculosis and rifampicin resistance[J].Future Microbiol,2011,6(9):1067-1082.
[14]World Health Organization.Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children[R].Geneva:WHO,2014.
[15]THERON G,ZIJENAH L,CHANDA D,et al.Feasibility,accuracy,and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa:a multicentre,randomised,controlled trial[J].Lancent,2014,383(9915):424-435.
[16]DETJEN A K,DINARDO A R,LEYDEN J,et al.Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in children:a systematic review and meta-analysis[J].Lancet Respir Med,2015,3(6):451-461.
[17]MOUSSA H S H,BAYOUMI F S,ALI A M.Evaluation of GeneXpert MTB/RIF assay for direct diagnosis of pulmonary tuberculosis[J].Saudi Med J,2016,37(10):1076-1081.
[18]梅枚,罗雁,刘会领.Xpert MTB/RIF检测在肠结核快速诊断中的应用观察[J].实用医学杂志,2016,32(18):3073-3075.
[19]RABNA P,RAMOS J,PONCE G,et al.Direct detection by the Xpert MTB/RIF assay and characterization of multi and poly drug-resistant tuberculosis in Guinea-Bissau,West Africa[J].PLoS One,2015,10(5):e0127536.
[20]GUENAOUI K,HARIR N,OUARDI A,et al.Use of gene Xpert Mycobacterium tuberculosis/rifampicin for rapid detection of rifampicin resistant Mycobacterium tuberculosis strains of clinically suspected multi-drug resistance tuberculosis cases[J].Ann Transl Med,2016,4(9):168.