耐多药结核病快速诊断试剂盒检测耐药结核分枝杆菌的评价  

Evaluation of the GenoType MTBDRplus assay for rifampin and isoniazid susceptibility testing of Mycobacterium tuberculosis

作　　者：桂晓虹[1] 徐鹏[2] 赵明[1] 王莉莉[1] 武洁[1] 李静[1] 高谦[3] 梅建[1] 

机构地区：[1]上海市疾病预防控制中心结核病防治科,200336 [2]南京农业大学 [3]复旦大学上海医学院教育部和卫生部医学分子病毒学重点实验室

出　　处：《中华结核和呼吸杂志》2010年第1期43-45,共3页Chinese Journal of Tuberculosis and Respiratory Diseases

基　　金：国家863课题资助项目（2006AA02Z423）

摘　　要：目的评价用耐多药结核病快速诊断（GenoType MTBDRplus）试剂盒检测耐利福平、异烟肼MTB的效果。方法选取75株MTB临床分离株，采用耐多药结核病快速诊断试剂盒检测其中的耐药MTB，评价其敏感度和特异度及可重复性，并与常规的药物敏感性试验方法相比较。结果耐多药结核病快速诊断试剂盒对上海地区的MTB临床分离株中耐利福平和耐异烟肼菌株的敏感度分别为98．0％和86．5％，对敏感菌株的特异度为100％。而在重复性试验中，耐多药结核病快速诊断试剂盒多次结果完全一致，重复性达到100％。结论耐多药结核病快速诊断作为快速检测耐药MTB的试剂盒，对耐利福平和耐异烟肼菌株具有较高的敏感度和特异度，在上海地区有较好的应用前景。Objective To evaluate the ability of GenoType MTBDRplus Assay for detection of rifampin （RFP） and isoniazid （INH） resitance in Mycobacterium tuberculosis. Methods Seventy-five clinical isolates were tested for tranditional drug susceptibility testing and GenoType MTBDRplus assay. The results were compared to assess the sensitivity and specificity of GenoType MTBDRplus assay. Results The sensitivity of GenoType MTBDRplus assays for detection of RFP and INH resistance were 98.0% and 86. 5%, respectively. In pan-susceptible isolates of Mycobacterium tuberculosis, the specificity was 100% for both RFP resistance and INH resistance. Conclusion With its high sensitivity and specificity, GenoType MTBDRplus assay is a promising rapid method to detect INH and RFP resistant Mycobacterium tuberculosis strains in Shanghai.

关 键 词：试剂盒 诊断 分枝杆菌 结核 利福平 异烟肼 

分 类 号：R52[医药卫生—内科学]