中国疾病控制体系实验室第1轮结核杆菌药物敏感试验室间质量评估分析

Analysis of First Round External Quality Assessment for MTB Drug Sensitivity Test within Disease Control Laboratories in China

目的评估中国疾病控制体系结核病实验室药物敏感性测试能力。方法国家结核病参比实验室下发30株结核杆菌至受评估的实验室，受评估实验室按照WHO推荐的罗氏培养基药物敏感性试验方法（比例法），进行药物敏感性试验，检测药物包括异烟肼（INH）、利福平（RFP）、链霉素（SM）、乙胺丁醇（EMB），并报告国家参比室，国家参比室将其结果与正确结果比对。结果4种药物的4个评估指标分别为，符合率：INH97％，RFP95％，SM89％，EMB93％；重复性：INH96％，RFP98％，SM86％，EMB94％；特异性：INH97％，RFP99％，SM89％，EMB96％：敏感性：INH97％，RFP65％，SM91％，EMB47％；各实验室4个评价指标均数比较，除敏感性差异有统计学意义外，其他4个检测值均高于85％，差异无统计学意义。结论除个别实验室在耐药检出能力上需提高外，其他参与实验室的药敏试验水平达到设定要求，1NH、RFP药物检测稳定，SM和EMB需要进一步标化。

Objective To evaluate laboratories drug sensitivity test ability within disease control system in China. Method National TB reference laboratory issued 30 Mycobactenum tuberculosis isolates to participating laboratories. Participating laboratories performed proportion LOwenstein- Jensen medium DST recommended by WHO, drugs are isoniazid （ INH ）, rifampin（ RFP ）, streptomycin （ SM ）, ethambutol（ EMB ）. National reference laboratory checked reporting result with judicial result. Result Evaluation indicators of 4 drugs are as follows： accordance rate： INH 97%, RFP 95%, SM 89%, EMB 93% ; Reproducibility： INH 96%, RFP 98%, SM 86%, EMB 94%; Specificity ： INH 97%, RFP 99%, SM 89%, EMB 96%; Sensitivity： INH 97% , RFP 65%, SM 91%, EMB 47%. Among laboratories, the mean sensitivity values of four drugs are statistically different, the other three mean values are all higher than 85%, with no statistically different. Conclusion Except very few laboratories, most participating laboratories met set requirements. Of the four medicines, INH. RFP results are relative stable, SM and EMB need to be further standardized.