Migliori G B, Ambrosetti M, Fattorini L, Penati V, Vaccarino P, Besozzi G, Ortona L, Saltini C, Orefici G, Moro M L, Lona E, Cassone A
Fondazione S. Maugeri, Clinica del Lavoro e della Riabilitazione, Care and Research Institute, Tradate, Italy.
Int J Tuberc Lung Dis. 2000 Oct;4(10):940-6.
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, 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.
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%.
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.
确定意大利22个地区实验室组成的临时网络中，异烟肼、利福平、乙胺丁醇和链霉素药敏试验（DST）的准确性。
方法、定义及参考结核分枝杆菌菌株源自世界卫生组织/国际防痨和肺部疾病联盟全球抗结核药物耐药性监测项目。根据项目所需技术技能、每年进行的DST数量及地理位置选择实验室。将结果（敏感/耐药菌株）与金标准（全球项目结果）进行比较。两轮计算敏感性（检测真耐药性的能力）、特异性（检测真敏感性的能力）、耐药性和敏感性的阳性预测值、效率及可重复性。
22个实验室中有18个完成了四种药物第一轮能力验证试验。敏感性为76.6%，特异性为97.2%，耐药试验的预测值为89.8%，敏感试验的预测值为86.8%，效率为87.8%，可重复性为92.8%。所有与全球项目结果一致性未达到≥90%的实验室进行了第二轮试验。总体而言，第二轮试验后，除特异性外的所有参数均有所改善，超过了90%。
在意大利建立了一个由15个地区实验室组成的网络，这些实验室符合确定结核分枝杆菌对四种主要抗结核药物敏感性的质量标准。
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