摘要
目的应用一种自主研发的新型结核分枝杆菌（Mycobacterium tuberculosis，MTB）快速药敏系统（MB-FS-1型）检测MTB对利福平（RIF）和异烟肼（INH）的耐药性，并对该系统的临床应用效果进行评价。方法采用新型药敏系统对115株MTB临床分离株进行药敏试验，异烟肼以及利福平分别设置三个浓度梯度，与BECTECMGIT960法对比分析药敏结果，评估该系统检测多药耐药结核（Multidrug—resistanttuberculosis，MDR—TB）的应用性价值。结果以BECTECMGIT960法为参考标准，MB-FS-1型快速药敏系统检测INH的敏感度、特异度、阳性预测值和阴性预测值分别为93．43％，94．88％，97．26％和88．10％，检测RIF分别为96．50％，94．83％，94．83％和96．50％。异烟肼浓度为0．2ug／ml或0．1ug／ml，利福平浓度为1．0ug／ml时两种药敏方法等效性最高，符合率分别为93．97％和95．69％。Kappa值分别为0．867和0．913，差异无统计学意义（P〉0．05）。结论该新型MTB快速药敏系统检测MTB对异烟肼和利福平的耐药性与BACTECMGIT960符合率高，具有快速、价廉、操作简便的优点，可作为临床检测MDR-TB的快速检测方法之一。
Objective To evaluation a new type rapid drug susceptibility system of MTB （ModeI：MB-FS-1 type） to determine MTB resistance to isoniazid and rifampin. Methods The drug susceptibility of 115 MTB clinical isolate strains were detected by the new type drug susceptibility system, isoniazid and rifampicin were set up three concentration, and the results were compared with that of BACTEC MGIT system. Results If the results obtained by automated system were taken as the golden standard,the sensitivity, specificity, positive and negative predictive value （PPV and NPV） of the MB-FS-1 type rapid drug susceptibility system to isoniazid was 93.43 %, 94.88%, 97. 26 % and 88. 10%, to rifampin was 96.50%, 94. 83%, 94.83% and 96.50%. Two kinds of susceptibility method was equivalent to the highest when the concentration of isoniazid was 0. 2ug/ml and 0. 1 ug/ml,while the concentration of rifampicin was 1.0 ug/ml. Concordance rate of the susceptibility to isoniazid and rifampin was 93.97 % and 95.69 %, Kappa value was 0. 867 and 0. 913, there was no statistical significance （P 〉0. 05）. Conclusion Concordance rate of the susceptibility to isoniazid and rifampin detected by the new type rapid drug susceptibility system of MTB and the automated system was high. The system is valuable for rapid clinical identification of MDR-TB as it is a rapid,inexpensive and simple method.
出处
《现代检验医学杂志》
CAS
2012年第1期35-39,共5页
Journal of Modern Laboratory Medicine
基金
基金项目：十一五“艾滋病和病毒性肝炎等重大传染病防治”重大专项（2009ZX10004-505）.
关键词
结核分枝杆菌
药敏试验
Mycobacterium tuberculosis
drug susceptibility test
