First Evaluation after Implementation of a Quality Control System for the Second Line Drug Susceptibility Testing of Mycobacterium tuberculosis Joint Efforts in Low and High Incidence Countries
First Evaluation after Implementation of a Quality Control System for the Second Line Drug Susceptibility Testing of Mycobacterium tuberculosis Joint Efforts in Low and High Incidence Countries
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DOI：
10.1371/journal.pone.0076765
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发表时间：
2013-10-11
期刊：
影响因子：
3.7
通讯作者：
Ruesch-Gerdes, Sabine
中科院分区：
文献类型：
--
作者：
Hillemann, Doris;Hoffner, Sven;Ruesch-Gerdes, Sabine
建立了涉及 27 个欧洲国家的三个网络/项目，以利用传统和分子方法研究二线药物 (SLD) 药敏试验的质量。 1. “波罗的海-北欧结核病实验室网络”由波罗的海-北欧国家的 11 个参考实验室组成。他们在第一阶段对一组 20 种结核分枝杆菌菌株进行了 SLD 测试。在几个实验室进行技术修改后，对第二组 10 株耐药菌株进行了测试。尽管氧氟沙星、卡那霉素和卷曲霉素的一致性始终很高，但氧氟沙星耐药菌株（从 88.9% 提高到 95.0%）和卷曲霉素耐药菌株（从 71.0% 提高到 88.9%）的性能改进最大。 2. 在 FP7 TB PAN-NET 项目（欧盟拨款协议 223681）内，建立了一个质量控制小组，以标准化一线药物 (FLD) 的 EQA（外部质量保证）以及表型和分子方法的 SLD 测试。这些菌株的特点是稳健性、测试结果明确以及二次耐药性比例低。 3.（欧洲参考实验室网络-TB）ERLN-TB网络使用表型和分子方法分析了四种不同的耐药性测试组合；在 2010 年的两轮中，31 个参与实验室首先对 5 个菌株进行了检测，随后在 2011 年和 2012 年对 10 个菌株和另外 6 个粗 DNA 提取物进行了常规 DST 和分子方法检查。总体而言，我们证明了发展实验室间网络对于建立质量保证和改进结核分枝杆菌 SLD 检测的重要性。
Three networks/projects involving 27 European countries were established to investigate the quality of second-line drug (SLD) susceptibility testing with conventional and molecular methods. 1. The "Baltic-Nordic TB-Laboratory Network" comprised 11 reference laboratories in the Baltic-Nordic States. They performed SLD testing in the first phase with a panel of 20 Mycobacterium tuberculosis strains. After several laboratories made technical changes a second panel of 10 strains with a higher proportion of resistant strains were tested. Although the concordance for Ofloxacin, Kanamycin, and Capreomycin was consistently high, the largest improvements in performance were achieved for the analysis of Ofloxacin resistant (from 88.9 to 95.0%), and Capreomycin resistant (from 71.0 to 88.9%) strains. 2. Within the FP7 TB PAN-NET project (EU Grant agreement 223681) a quality control panel to standardize the EQA (External Quality Assurance) for first-line drugs (FLD) and SLD testing for phenotypic and molecular methods was established. The strains were characterized by their robustness, unambiguous results when tested, and low proportion of secondary drug resistances. 3. The (European Reference Laboratory Network-TB) ERLN-TB network analyzed four different panels for drug resistance testing using phenotypic and molecular methods; in two rounds in 2010 the 31 participating laboratories began with 5 strains, followed by 10 strains and 6 additional crude DNA extracts in 2011 and 2012 were examined by conventional DST and molecular methods. Overall, we demonstrated the importance of developing inter-laboratory networks to establish quality assurance and improvement of SLD testing of M. tuberculosis.