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中国多中心研究 BACTEC MGIT 960 系统二线药物敏感性检测结核分枝杆菌。

Multicenter research on the BACTEC MGIT 960 system for the second-line drugs susceptibility testing of Mycobacterium tuberculosis in China.

机构信息

National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention/State Key Laboratory for Infectious Disease Prevention and Control/National Reference Laboratory of Tuberculosis, Beijing 102206, China.

出版信息

Diagn Microbiol Infect Dis. 2013 Dec;77(4):330-4. doi: 10.1016/j.diagmicrobio.2013.08.028. Epub 2013 Oct 3.

Abstract

The reliability of the BACTEC MGIT 960 system for the second-line drugs (capreomycin [CPM], kanamycin [KAN], ofloxacin [OFX] and ethionamide [ETH]) susceptibility testing (DST) of Mycobacterium tuberculosis (M. tuberculosis) was compared to that of traditional Lowenstein-Jensen (L-J) proportion method (PM) among four different sites in China. After resolution of discrepant results by retesting the strains using both methods in the National Reference Laboratory of tuberculosis, the overall concordance values between the 2 systems were 99.7% (kappa value: 0.97) for CPM, 99.7% (kappa value: 0.97) for KAN, 100.0% (kappa value: 1.00) for OFX, and 98.6% (kappa value: 0.95) for ETH. The average turnaround time with BACTEC MGIT 960 system among four sites was 8.9 ± 1.7 days, significantly shorter than 28 days with the traditional L-J PM. Therefore, the BACTEC MGIT 960 system is a reliable and rapid method for the second-line drug susceptibility testing of tuberculosis in China. Notably, a stricter quality control program should be routinely carried out when clinical laboratories perform the second-line DST with BACTEC MGIT 960 system.

摘要

本研究比较了 BACTEC MGIT 960 系统与传统 Lowenstein-Jensen(L-J)比例法(PM)在我国四个不同地点对结核分枝杆菌(M. tuberculosis)二线药物(卷曲霉素[CPM]、卡那霉素[KAN]、氧氟沙星[OFX]和乙胺丁醇[ETH])药敏试验(DST)的可靠性。在国家结核病参考实验室通过两种方法重新检测菌株解决了不一致的结果后,两种系统之间的总体一致性值分别为 99.7%(kappa 值:0.97)用于 CPM、99.7%(kappa 值:0.97)用于 KAN、100.0%(kappa 值:1.00)用于 OFX 和 98.6%(kappa 值:0.95)用于 ETH。四个地点使用 BACTEC MGIT 960 系统的平均周转时间为 8.9±1.7 天,明显短于传统 L-J PM 的 28 天。因此,BACTEC MGIT 960 系统是一种可靠且快速的中国二线药物结核病药敏检测方法。值得注意的是,临床实验室使用 BACTEC MGIT 960 系统进行二线 DST 时,应常规进行更严格的质量控制计划。

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