OBJECTIVE:To determine the accuracy of drug-susceptibility testing (DST) for isoniazid, rifampicin, ethambutol and streptomycin in a provisional network of 22 regional laboratories in Italy. METHODS:Methods, definitions and reference Mycobacterium tuberculosis strains were derived from the WHO/IUATLD Global Project on Anti-tuberculosis Drug Resistance Surveillance. The laboratories were selected based on technical skills required by the project, the number of DST performed annually and geographic localisation. The results (sensitive/resistant strain) were compared with the gold standard (global project results). Sensitivity (ability to detect true resistance), specificity (ability to detect true susceptibility), positive predictive values for resistance and susceptibility, efficiency and reproducibility were calculated in two rounds. RESULTS:Eighteen of 22 laboratories completed the first round of proficiency testing for the four drugs. Sensitivity was 76.6%, specificity 97.2%, predictive value of a resistant test 89.8% and of a susceptible test 86.8%, efficiency 87.8% and reproducibility 92.8%. A second round was performed by all those laboratories that did not achieve > or = 90% agreement with the results of the Global Project. Overall, after the second round, all the parameters except specificity improved, exceeding 90%. CONCLUSIONS:A network of 15 regional laboratories that fulfil the quality criteria for determining the susceptibility of M. tuberculosis to the four primary antituberculosis drugs was established in Italy.

译文

目的:在意大利由22个地区实验室组成的临时网络中,测定异烟肼,利福平,乙胺丁醇和链霉素的药敏试验(DST)的准确性。
方法:方法,定义和参考结核分枝杆菌菌株均来自WHO / IUATLD全球抗结核药物耐药性监测项目。根据项目所需的技术技能,每年执行的DST数量和地理定位来选择实验室。将结果(敏感/耐药菌株)与金标准(全球项目结果)进行比较。分两轮计算敏感性(检测真正耐药性的能力),特异性(检测真正耐药性的能力),耐药性和敏感性,效率和可重复性的阳性预测值。
结果:22个实验室中的18个完成了对这四种药物的第一轮能力验证。敏感性为76.6%,特异性为97.2%,耐药性测试的预测值为89.8%,易感性测试的预测值为86.8%,效率为87.8%,再现性为92.8%。所有未与全球项目结果达成或超过90%协议的实验室都进行了第二轮。总体而言,在第二轮之后,除特异性以外的所有参数均得到改善,超过90%。
结论:在意大利建立了一个由15个地区实验室组成的网络,这些网络符合确定结核分枝杆菌对四种主要抗结核药物的敏感性的质量标准。

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