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

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、异炳肼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.

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

Objective To evaluate the ability of GenoType MTBDRplas 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(R) 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.