Clinical trial of BACTEC MGIT 960 for drug susceptibility testing on Mycobacterium tuberculosis
CHEN Zhong-nan1, ZHAO Li-li2, YI Song-lin1, TAN Xiao1, HU Pei-lei1, BAI Li-qiong1, WAN Kang-lin2, TAN Yun-hong1
1.Hunan Provincial Chest Hospital, Tuberculosis Control Institution of Hunan Province, Hunan 410013, China; 2.National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention/State Key Laboratory for Infectious Disease Prevention and Control, Beijing 102206, China
Abstract:The purpose of this study was to evaluate the effects of BACTEC MGIT 960 for detecting the sensitivity of 8 drugs against Mycobacterium tuberculosis (M. tuberculosis). The M. tuberculosis clinical strains were isolated from sputum specimens of the patients with tuberculosis (TB) in the Hunan Provincial Chest Hospital. Drug sensitivity test (DST) of 8 drugs was conducted by means of L-J proportional method and MGIT960 method respectively. The 4 first-line drugs used in this study were Isoniazid (INH), Rifampicin (RFP), Streptomycin (SM), and Ethambutol (EMB), and the 4 second-line drugs were Capreomycin (CPM), Kanamycin (KAN), Ofloxacin (OFLX), and Ethionamide (ETH). After the susceptibility test for the 4 first-line drugs were conpleted, the strains which were drug-resistant to any kind of the 4 first-line drugs were selected for testing the susceptibility of the 4 second drugs. Statistics analysis was conducted by Kappa and t tests, and the P value for significance was 0.05. The sensitivity to the 4 first-line drugs of 212 clinincal M. tuberculosis isolates was tested. And then, the 90 strains which were resistant to any kind of the 4 first-lin drugs were tested for their sensitivity to the 4 second-line drugs. Compared with the results of L-J proportional method, the accuracy rates and the Kappa values of the results with MGIT 960 method for testing the sensitivity to INH, RFP, SM, EMB, CPM, KAN, OFLX, and ETH were 96.0% and 0.92, 99.0% and 0.98, 99.0% and 0.97, 0.96.0% and 0.81, 100.0% and 1.00, 99.0% and 0.85, 96.0% and 0.88, and 94.0% and 0.73, respectively. The average time of completing DST for the first- and second-line drugs with MGIT 960 and L-J proportional method were 8.10 and 10 days, 30 and 30 days, respectively. There were significant difference among them (P<0.05). It’s suggested that MGIT 960 is better than L-J proportional method in testing the susceptibilities of M. tuberculosis to the first- and the second-line drugs for its accuracy and shorter testing time. MGIT 960 is time-saving and effective for rational use of drugs in clinical.
陈忠南,赵丽丽,易松林,谭笑,胡培磊,白丽琼,万康林,谭云洪. BACTEC MIGT960在结核分枝杆菌药物敏感性试验中的临床研究[J]. 中国人兽共患病学报, 2013, 29(2): 166-169.
CHEN Zhong-nan, ZHAO Li-li, YI Song-lin, TAN Xiao, HU Pei-lei, BAI Li-qiong, WAN Kang-lin, TAN Yun-hong. Clinical trial of BACTEC MGIT 960 for drug susceptibility testing on Mycobacterium tuberculosis. Chinese Journal of Zoonoses, 2013, 29(2): 166-169.
[1]Iseman MD, Heifets LB. Rapid detection of tuberculosis and drug-resistant tuberculosis[J]. N Engl J Med,2006, 355(15): 1606-1608. DOI: 10.1056/NEJMe068173 [2]Siddiqi SH, Rüsch-Gerdes S. MGITTM procedure manual: Mycobacteria Growth Indicator Tube (MGIT) culture and drug susceptibility demonstration projects[M]. Geneva: Foundation for Innovative New Diagnostics, 2006. [3]Shen X, Mei J, Shen M, et al. The effect of drug resistance on treatment of tuberculosis[J]. J Chin Antituberculosis Assoc, 2006, 28(5): 309-312. (in Chinese) 沈鑫,梅建,沈梅, 等. 耐药对肺结核病治疗效果的影响.[J]. 中国防痨杂志, 2006, 28 (5) : 309-312. [4]World Health Organization. Policy guidance on drug-ausceptibility testing (DST) of second-line antituberculosis drugs[M]. Geneva: World Health Organization, 2008. [5]Zhao LL, Wan KL, Xia Q, et al. MGIT 960 and proportion method for drug susceptibility testing of Mycobacterium tuberculosis[J]. J Med Res, 2011, 40(5): 40-43. (in Chinese) 赵丽丽, 万康林, 夏强, 等. MGIT 960和比例法对结核分枝杆菌药物敏感性试验的对比研究[J]. 医学研究杂志,2011, 40(5): 40-43. [6]Zhang J, Jiang J, Zhang H, et al. Comparing analysis of Mycobacterium Bactec MGIT960 culture with Lowenstein-Jensen culture method[J]. Chin J Antituberculosis, 2011, 11(6): 361-365. (in Chinese) 张娟, 蒋俊, 张红, 等. MGIT960与罗氏培养法在结核分枝杆菌培养及药敏试验中的比对分析[J]. 中国防痨杂志, 2011,11(6):361-365. [7]Liu XY, Lin JX, Zheng HC, et al. Evaluation of a combined technique composed of three methods on rapid diagnose of tuberculosis[J]. Mod Hosp, 2011, 11(7): 331-335. (in Chinese) 刘晓燕, 林健雄, 郑惠聪, 等. 三种方法组成的结核病快速诊断技术的评价[J]. 现代医院, 2011, 11(7): 331-335.