两种结核分枝杆菌药物敏感性试验室间质量评估方法评价

目的探讨药敏试验复检和熟练度测试两种方法在药敏检测实验室室间质量评估中的应用,选择适当的室间质控方法。方法湖北省结核病参比实验室转种30株国家一线药物熟练度测试菌株,下发至4个地市实验室进行熟练度测试,同时省级随机抽取4个地市已完成一线药敏检测的临床菌株各30株进行复检。实验室均按照《结核病诊断实验室检测规程》中比例法(罗氏培养基)进行药敏测试,省参比实验室将两种评估方法得到的结果进行比较分析。结果 4个实验室药敏试验复检和熟练度测试两种方法得到4种药物平均符合率分别为INH 94.8%(90.0%~100.0%)和100.0%、RFP 94.8%(92.3%~96.2%)和98.3%(96.7%~100.0%)、SM90.7%(84.6%~95.0%)和91.7%(90.0%~93.3%)、EMB 92.8%(88.5%~96.0%)和87.5%(80.0%~93.3%),符合率均达到了WHO和国家结核病参比实验室药物敏感性检测的要求。结论药敏试验复检和熟练度测试两种方法进行室间质量控制,满足对实验室能力评价的需要,质控结果可靠,达到国家要求。

Evaluation of two external quality assessment methods for testing susceptibility of Mycobacterium tuberculosis to anti-tuberculosis drugs

Objective To explore the applications of reexamination and proficiency testing in external quality assessment of laboratory drug susceptibility testing of Mycobacterium tuberculosis to anti-tuberculosis drugs for selecting appropriate external quality control between laboratories. Methods Thirty Mycobacterium tuberculosis testing strains from national reference lab were sent to four municipal tuberculosis laboratories for proficiency testing. At the same time, thirty clinical Nycobacterium tuberculosis strains being tested the susceptibility to first-line drug were randomly selected from each of four labs by provincial TB reference lab. According to TB diagnostic lab testing procedures, the latter 120 strains were reexamined by using the proportion method （Roche medium）. And the results the two methods were comaratively analyzed by provincial lab. Results The results of reexamination and proficiency testing in four laboratories showed the average coincidence rates of four drugs were INH 94.8%（90.0～100.0%） and 100%,RFP 94.8% （92.3～96.2%）and 98.3% （96.7～100.0%）, SM 90.7%（84.6～95.0%） and 91.7%（90.0～93.3%）, EMB 92.8%（88.5～96.0%） and 87.5%（80.0～93.3%）, respectively, all met the requirements of WHO and national TB reference labs. Conclusion The two external quality assessment methods based on reexamination and proficiency testing meet requirements for laboratory capacity evaluation and the results are reliable .