【摘要】 目的评估福建省一线和二线抗结核药物敏感性试验的测试能力。方法采用比例法,对30株质控菌株进行一线抗结核药(INH、RFP、SM和EMB)和二线抗结核药(Km、Am、Cm、Ofx)敏感性测定,结果给国家结核病参比实验室,由国家参比实验室将结果与标准结果比对。结果各轮测试中省参比实验室的平均符合率分别为:INH 96.60%,RFP 97.78%,SM 96.61%,EMB 92.72%;Km 96.57%,Am 98.62%,Cm 96.62%,Ofx 99.30%。第一轮室间质量评估一线药物的平均符合率分别为INH 96.67%,RFP 100.00%,EMB 95.84%,SM 96.67%,二线药物的平均符合率分别为Km 95.84%,Am 97.50%,Cm 86.67%,Ofx 100.00%。第二轮评估中符合率分别为INH 100.00%,RFP 98.34%,EMB 99.17%,SM 95.84%。第二轮中4种二线药物的符合率均为100.00%。结论福建省疾病预防控制中心结核病参比实验室对一线和二线抗结核药药敏检测水平已经达到设定的要求,对INH、RFP、SM和Km、Am、Ofx的药敏检测稳定性高。更多还原

【Abstract】 Objective To evaluate the performance of drug susceptibility testing(DST)against the first-line(FL)and second-line(SL)anti-tuberculosis drugs in tuberculosis(TB)laboratories in Fujian province. Methods Thirty Mycobacterium tuberculosis isolates issued by the national reference laboratory were performed for FL(INH,RFP,SM,EMB)and SL(Km,Am,Cm,Ofx)DST using the method of proportion,the testing results were reported to the national reference laboratory,then the results were checked and compared with the judicial results. Results The mean accordance rate of the drugs evaluated in Fujian provincial reference laboratory was INH 96.60%,RFP 97.78%,SM 96.61%,EMB92.72%;Km 96.57%,Am 98.62%,Cm 96.62%,and Ofx 99.30%.The mean accordance rate of drugs evaluated in round1 external quality assessment was INH 96.67%,RFP 100.00%,EMB 95.84%,SM 96.67%,Km 95.84%,Am97.50%,Cm 86.67%,and Ofx 100.00%.And the mean accordance rate of drugs evaluated in round 2 was INH100.00%,RFP 98.34%,EMB 99.17%,SM 95.84% and 100.00%for all the four SL drugs. Conclusion The TB reference laboratories in Fujian province meet the requirement criteria.The DST results of INH,RFP,SM,Km,Am and Ofx are stable.更多还原