MDR-TB诊断试剂盒鉴定广东结核分枝杆菌复合群及RIF和INH药敏效果分析

Evaluation of the Genotype MTBDRplus assay for detection of Mycobacterium tuberculosis complex and RIF/INH resistance in Guangdong

目的评价耐多药结核病(MDR-TB)快速诊断试剂盒对广东地区结核分枝杆菌复合群的鉴定效果及利福平(RIF)和异烟肼(INH)的药敏检测效果。方法选取151份痰标本和150份细菌培养物,采用MDR-TB快速诊断试剂盒对其进行菌群鉴定及RIF和INH药敏检测,结果分别与常规法进行比较。结果与常规生化菌种鉴定结果相比,两者鉴定结果一致率为96.7%(291/301);与常规比例法药敏试验结果相比,诊断试剂盒检测单耐RIF的灵敏度为94.1%(64/68),检测单耐INH的灵敏度为87.7%(57/65),检测RIF和INH皆耐药株的灵敏度为79.3%(46/58),检测RIF和INH皆敏感株的特异性为100%。结论该试剂盒能简单快速地鉴定结核分枝杆菌复合群,检测RIF和INF的敏感性高、特异性好,在广东地区应用前景较好。

Objective To evaluate the Genotype MTBDRplus assay for the detection of Mycobacterium tuberculosis complex and its RIF/INH resistance.Methods 151 sputum samples and 150 isolates were identified for their flora and their RIF/INH resistance by Genotype MTBDRplus assay.The results were compared to those detection by conventional methods.Results The concordance rate of flora identification between the Genotype MTBDRplus assay and conventional method was 96.7%（291/301）.Compared to conventional drug susceptibility test,the resistance to antibiotics determined by Genotype MTBDRplus assay,to the specificity for RIF only was 94.1%（64/68）,to that of INH only was 87.7%（57/65）,and that of both RIF and INH was 79.3%（46/58）.The specificity for susceptible to both RIF and INH was 100%.Conclusion Genotype MTBDRplus assay is a simple,rapid diagnostic method for identifying the mycobacterium tuberculosis complex,and their RIF/INH resistance,so,Genotype MTBDRplus assay is a promising method for diagnosis of mycobacterium complex.