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[用于结核分枝杆菌药敏试验的BACTEC MGIT 960系统:一项使用外部质量评估菌株的研究]

[BACTEC MGIT 960 system for drug susceptibility testing of Mycobacterium tuberculosis: a study using external quality assessment strains].

作者信息

Kobayashi Ikuo, Abe Chiyoji, Mitarai Satoshi

机构信息

Nippon Becton Dickinson Company, Ltd., 1 Gotanda, Tsuchifune, Fukushima-shi, Fukushima 960-2152 Japan.

出版信息

Kekkaku. 2006 Feb;81(2):57-62.

Abstract

OBJECTIVE

To evaluate the performance of the BACTEC MGIT 960 system for drug susceptibility testing (MGIT AST) of Mycobacterium tuberculosis to isoniazid, rifampin, streptomycin and ethambutol.

DESIGN

Fifty external quality assessment strains of M. tuberculosis provided by the Coordinating Centers of WHO/ IUATLD were tested by BACTEC MGIT 960 system, and the results were compared with the referee results of the WHO/IUATLD Supranational Reference Laboratory Network (SRLN).

RESULTS AND CONCLUSION

Overall concordance rates of the results obtained by MGIT AST and the referee results of the SRLN were 97.3% for four first-line drugs. Agreement rates were particularly high for isoniazid, rifampin, and streptomycin (agreement rate of over 97%), but somewhat lower for ethambutol, which relates to a lower sensitivity of MGIT AST. Turnaround times from inoculation to drug susceptibility results ranged from 6 to 13 days for the MGIT AST system with a median time of 7 days; this contrasted with three weeks for the proportion method using Middlebrook 7H10 agar, indicating that MGIT AST system has the potential to consistently meet with the turnaround time guidelines suggested by the Centers for Disease Control and Prevention of the United States. These results demonstrate that the fully automated BACTEC MGIT 960 AST system is useful for the rapid diagnosis of drug resistant tuberculosis.

摘要

目的

评估BACTEC MGIT 960系统对结核分枝杆菌进行异烟肼、利福平、链霉素和乙胺丁醇药敏试验(MGIT AST)的性能。

设计

采用BACTEC MGIT 960系统对世界卫生组织/国际防痨和肺部疾病联盟协调中心提供的50株结核分枝杆菌外部质量评估菌株进行检测,并将结果与世界卫生组织/国际防痨和肺部疾病联盟跨国参考实验室网络(SRLN)的参比结果进行比较。

结果与结论

对于四种一线药物,MGIT AST获得的结果与SRLN参比结果的总体一致率为97.3%。异烟肼、利福平及链霉素的符合率特别高(超过97%),但乙胺丁醇的符合率略低,这与MGIT AST较低的灵敏度有关。MGIT AST系统从接种到获得药敏结果的周转时间为6至13天,中位数为7天;相比之下,使用Middlebrook 7H10琼脂的比例法需要三周时间,这表明MGIT AST系统有可能持续满足美国疾病控制与预防中心建议的周转时间指南。这些结果表明,全自动BACTEC MGIT 960 AST系统有助于快速诊断耐多药结核病。

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