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在2021年在中国使用商业汁微稀释板测试Mycobacterium结核复合物的药物敏感性测试的熟练测试

Hui Xia¹, Yuanyuan Song¹, Yang Zheng¹

¹National Tuberculosis Reference Laboratory, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.

Journal of global antimicrobial resistance

|December 10, 2023

概括

在中国进行Mycobacterium结核病药物敏感性测试的汁微稀释 (BMD) 板显示了不同的性能和药物布局. 由于板材质量和实验室程序的不一致性,迫切需要标准化.

科学领域:

微生物学微生物学
临床诊断临床诊断临床诊断
制药科学制药科学

背景情况:

苏微稀释 (BMD) 是Mycobacterium结核病药物敏感性测试的一个关键方法.
在中国缺乏对商业BMD板的系统评估.
能力测试为评估诊断性能提供了有价值的数据.

研究的目的:

审查在中国使用的商业苏微稀释 (BMD) 板的信息.
为了评估BMD板的性能,用于Mycobacterium结核病药物敏感性测试.
确定标准化和质量控制方面需要改进的领域.

主要方法:

来自中国45个实验室的技能测试结果的回顾性分析 (2021年).
关键信息的比较:药物布局,度,储存,程序和解释标准.
对十种关键抗结核药物BMD板的性能分析.

主要成果:

评估了来自四家制造商的八种BMD板.
对于10种药物,总体灵敏度为93.9%,特异性为99.1%.
最低的敏感性观察到的是勒沃素 (84.8%) 和莫西素 (86.4%); 最低的特异性是德拉曼尼德 (94.4%).

结论:

在中国,商业 BMD 板在药物布局和操作程序方面表现出显著的变化.
迫切需要对BMD板和相关实验室实践进行标准化.
对于某些药物来说,低于最佳的性能可能表明有板质量或实验室能力的问题.

关键词:

药物敏感性测试是对药物敏感性的测试.最小的抑制度最小的抑制度结核菌菌菌菌复合体结核菌菌结核菌复合体

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