Xpert MTB/RIF联合GenoType MTBDRplus在衢州地区耐多药结核病快速诊断中的应用研究
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摘要
目的评估Xpert MTB/RIF联合结核分枝杆菌及耐药基因检测试剂盒(GenoType MTBDRplus)在衢州市耐多药结核病快速诊断中的应用价值。方法收集2016年1月—2017年12月衢州市抗酸染色阳性痰液。县级实验室Xpert MTB/RIF检测、培养;市级实验室GenoType MTBDRplus检测、菌种鉴定和药敏。统计Xpert MTB/RIF联合GenoType MTBDRplus诊断耐多药结核病的灵敏度、特异性、阳性预测值、阴性预测值、Kappa值、诊断时间和成本。结果以培养和液体药敏为金标准,Xpert MTB/RIF联合GenoType MTBDRplus诊断耐多药结核的灵敏度为82.76%(48/58),特异性为99.50%(1380/1387)、阳性预测值为87.27%(48/55)、阴性预测值为99.28%(1380/1390)、Kappa为0.84≥0.75;Xpert MTB/RIF联合GenoType MTBDRplus诊断时间平均为3.15 d;Xpert MTB/RIF联合GenoType MTBDRplus检出1例MDR-TB的成本是5 470元。结论 Xpert MTB/RIF和GenoType MTBDRplus诊断耐多药结核病具有较高的灵敏度和特异性,有利于耐多药患者早期诊断和早期治疗。
Objective To evaluate the value of Xpert MTB/RIF combined with GenoType MTBDRplus in the rapid diagnosis of MDR-TB in Quzhou. Methods Xpert MTB/RIF detection and solid culture were performed in the county level laboratory, GenoType MTBDRplus detection of rifampicin resistant sputum, gene chip identification were performed in municipal laboratory from January 2016 to 2017 December. The sensitivity, specificity,positive predictive value, negative predictive value and Kappa value of Xpert MTB/RIF combined with GenoType MTBDRplus in the rapid diagnosis of MDR-TB in Quzhou. Results When solid culture and liquid drug sensitivity as the gold standard, Xpert MTB/RIF combined with GenoType MTBDRplus in diagnosis of multi drug resistant tuberculosis sensitivity was 82.76%(48/58), the specificity was 99.50%(1380/1387), the positive predictive value was 87.27%(48/55) and the negative predictive value was 99.28%(1380/1390), Kappa was 0.84. XpertMTB/RIF combined with GenoType MTBDRplus in diagnosis of MDR-TB time was averaged 3.15 days. Xpert MTB/RIF combined with GenoType MTBDRplus detection 1 cases of MDR-TB was 5470. Conclusion Xpert MTB/RIF and GenoType MTBDRplus have high sensitivity and specificity in the rapid diagnosis of MDR-TB. They can be used for early diagnosis and early treatment of MDR-TB.
Objective To evaluate the value of Xpert MTB/RIF combined with GenoType MTBDRplus in the rapid diagnosis of MDR-TB in Quzhou. Methods Xpert MTB/RIF detection and solid culture were performed in the county level laboratory, GenoType MTBDRplus detection of rifampicin resistant sputum, gene chip identification were performed in municipal laboratory from January 2016 to 2017 December. The sensitivity, specificity,positive predictive value, negative predictive value and Kappa value of Xpert MTB/RIF combined with GenoType MTBDRplus in the rapid diagnosis of MDR-TB in Quzhou. Results When solid culture and liquid drug sensitivity as the gold standard, Xpert MTB/RIF combined with GenoType MTBDRplus in diagnosis of multi drug resistant tuberculosis sensitivity was 82.76%(48/58), the specificity was 99.50%(1380/1387), the positive predictive value was 87.27%(48/55) and the negative predictive value was 99.28%(1380/1390), Kappa was 0.84. XpertMTB/RIF combined with GenoType MTBDRplus in diagnosis of MDR-TB time was averaged 3.15 days. Xpert MTB/RIF combined with GenoType MTBDRplus detection 1 cases of MDR-TB was 5470. Conclusion Xpert MTB/RIF and GenoType MTBDRplus have high sensitivity and specificity in the rapid diagnosis of MDR-TB. They can be used for early diagnosis and early treatment of MDR-TB.
引文
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[12] 向敏,张泓,陈玲.结核分枝杆菌耐利福平机制及其研究进展[J].海南医学,2017,28(17):2853-2856.
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[14] 王桂荣,付育红,梁倩,等.应用多重PCR方法快速鉴定结核分枝杆菌复合群与非结核分枝杆菌的研究[J].中国防痨杂志,2013,35(9):686-689.
[15] 徐礼锋,余旭良,张峰,等.液体MGIT培养联合Xpert MTB/RIF快速检测结核分枝杆菌及其耐药性的研究[J].中华检验医学杂志,2016,39(4):272-276.
[16] MATHYS V,VAN D E VYVERE M,DE DROOGH E,et al.Falsepositive rifampicin resistance on Xpert MTB/RIF caused by a silent mutation in the rpoB gene[J].Int J Tuberc Lung Dis,2014,18(10):1255-1257.
[17] FOLKVARDSEN D B,THOMSEN V ?,RIGOUTS L,et al.Rifampin heteroresistance in Mycobacterium tuberculosis cultures as detected by phenotypic and genotypic drug susceptibility test methods[J].J Clin Microbiol,2013,51(12):4220-4222.
[18] 欧喜超,夏辉,李强,等.结核分枝杆菌及利福平耐药核酸扩增检测成本分析[J].中国防痨杂志,2013,35(9):723-728.
[19] 杨蕾,李丽莉,王国治.对世界卫生组织关于结核病基因诊断技术建议的几点探讨[J].中华结核和呼吸杂志,2014,37(1):69-71.
[20] 郝兴亮,蔺景双,崔丽华,等.结核感染T细胞斑点试验联合电子支气管镜检查快速诊断菌阴肺结核价值[J].中华实用诊断与治疗杂志,2016,30(10):1039-1040.
[2] PRASAD R,GUPTA N,SINGH M.Multidrug resistant turberculosis:trends and control[J].Indian J Chest Dis Allied Sci,2014,56(4):237-246.
[3] ZUMLA A,GEORGE A,SHARMA V,et al.The WHO 2014 Global tuberculosis report—further to go[J].Lancet Glob Health,2015,3(1):elO-el2.
[4] 邹远妩,刘尚武,朱蕾,等.Xpert MTB/RIF检测结核分枝杆菌及其耐药性在结核病辅助诊断中的临床价值[J].临床肺科杂志,2015,20(3):568-570.
[5] 汪领,胡正义,郭琪.基因芯片技术检测对结核分枝杆菌耐药的诊断价值[J].中华实用诊断与治疗杂志,2018,32(4):393-394.
[6] SHARMA S K,KOHLI M,YADAV R N,et al.Evaluating the diagnostic accuracy of Xpert MTB/RIF assay in pulmonary tuberculosis[J].PLoS One,2015,10(10):e141011.
[7] 王洪秀,杨景卉,王暖,等.GenoType MTBDRplus VER2.0对痰样本结核分枝杆菌及其耐药性检测的应用评价[J].检验医学,2017,32(5):410-414.
[8] 李永文,李新旭,邓云峰,等.中国开展Genetype、MTBdR plus检测结核分枝杆菌对异烟肼和利福平耐药性的Meta分析[J].中华传染病杂志,2016,34(8):494-500.
[9] 耿红,李永文,李新旭,等.中国开展基因芯片检测结核分枝杆菌对异烟肼和利福平耐药性的Meta分析[J].中华传染病杂志,2014,32(6):357-363.
[10] 王英全,岳昌武.结核分枝杆菌耐药主要分子机制及检测方法研究进展[J].贵州医药,2017,41(4):418-420.
[11] MBOOWA G,NAMAGANDA C,SSENGOOBA W.Rifampicin resistance mutations in the 81 bp RRDR of rpoB gene in Mycobacterium tuberculosis clinical isolates using Xpert MTB/RIF in Kampala,Uganda:a retrospective study[J].BMC Infect Dis,2014,14:181.
[12] 向敏,张泓,陈玲.结核分枝杆菌耐利福平机制及其研究进展[J].海南医学,2017,28(17):2853-2856.
[13] FELKEL M,EXNER R,SCHLEUCHER R,et al.Evaluation of Mycobacterium Tuberculosis drug susceptibility in clinical specimens from Nigeria using genotype MTBDRplus and MTBDRsl assays[J].Eur J Microbiol Immunol(Bp),2013,3(4):252-257.
[14] 王桂荣,付育红,梁倩,等.应用多重PCR方法快速鉴定结核分枝杆菌复合群与非结核分枝杆菌的研究[J].中国防痨杂志,2013,35(9):686-689.
[15] 徐礼锋,余旭良,张峰,等.液体MGIT培养联合Xpert MTB/RIF快速检测结核分枝杆菌及其耐药性的研究[J].中华检验医学杂志,2016,39(4):272-276.
[16] MATHYS V,VAN D E VYVERE M,DE DROOGH E,et al.Falsepositive rifampicin resistance on Xpert MTB/RIF caused by a silent mutation in the rpoB gene[J].Int J Tuberc Lung Dis,2014,18(10):1255-1257.
[17] FOLKVARDSEN D B,THOMSEN V ?,RIGOUTS L,et al.Rifampin heteroresistance in Mycobacterium tuberculosis cultures as detected by phenotypic and genotypic drug susceptibility test methods[J].J Clin Microbiol,2013,51(12):4220-4222.
[18] 欧喜超,夏辉,李强,等.结核分枝杆菌及利福平耐药核酸扩增检测成本分析[J].中国防痨杂志,2013,35(9):723-728.
[19] 杨蕾,李丽莉,王国治.对世界卫生组织关于结核病基因诊断技术建议的几点探讨[J].中华结核和呼吸杂志,2014,37(1):69-71.
[20] 郝兴亮,蔺景双,崔丽华,等.结核感染T细胞斑点试验联合电子支气管镜检查快速诊断菌阴肺结核价值[J].中华实用诊断与治疗杂志,2016,30(10):1039-1040.