【摘要】 目的比较进口试剂和国产试剂在检测结核分枝杆菌对利福平、异烟肼耐药基因差异,探讨国产试剂的临床使用价值方法 152株经罗氏培养阳性的菌株,分别用德国Hain life science Gmb H生产的Geno TypeMTBDRplus、亚能生物技术(深圳)有限公司生产的基因探针试剂检测利福平、异烟肼耐药基因,并与传统的药敏结果作比较。结果 152例菌株中有148株纳入比较,其中进口试剂、国产试剂和罗氏培养法对利福平、异烟肼耐药的检出率分别为47.30%(70/148),43.24%(64/148);50%(74/148),41.89(62/148);48.65%(72/148),47.30%(70/148),国产试剂与进口试剂、罗氏培养法相比,对利福平、异烟肼耐药检出率均无统计学差异(P>0.05).以罗氏培养的药敏结果为金标准,国产试剂和进口试剂对利福平、异烟肼耐药的检出敏感性和特异性均无统计学差异(P>0.05)。结论国产试剂检测异烟肼和利福平耐药的敏感性与特异性与进口试剂相接近,且操作简便,价格便宜,适合基层医院对结核分枝杆菌耐药性的快速检测。更多还原

【Abstract】 Objective To compare the differences of domestic and imported reagents on detecting drug resistance gene of Mycobacterium tuberculosis against isoniazid and rifampin. Methods Drug resistance was detected by reagent with Germany Hain life science Gmb H production MTBDRplus and Yaneng Biological Technology Co.( Shenzhen) analysis in 152 strains with L-J culture-positive,and the results of L-J culture were compared. Results148 strains were compared in 152 cases. The rates of drug resistance against rifampin and isoniazid were 47. 30%( 70/148) Vs 43. 24%( 64/148),50%( 74/148) Vs 41. 89%( 62/148) and 48. 65%( 72/148) Vs 47. 30%( 70/148) by imported reagents,domestic reagents and L-J culture respectively. The rates of drug resistance against rifampin and isoniazid showed no significant difference among imported reagents,domestic reagents and L-J culture( P > 0. 05). The sensitivity and specificity had no significant difference in detecting drug resistance against isoniazid and rifampin between imported and domestic reagents as the gold standard of l-J susceptibility( P > 0. 05). Conclusion The sensitivity and specificity about domestic reagent for detecting isoniazid and rifampicin are closer to imported reagents. Domestic reagents fit for basic hospital on detecting drug resistance of Mycobacterium tuberculosis rapidly,because it is simple and cheap.更多还原