世界卫生组织《关于更新使用结核分枝杆菌及其耐药性核酸扩增检测技术的建议》的启示

doi:10.3969/j.issn.1000-6621.2021.08.002

中国防痨杂志 ›› 2021, Vol. 43 ›› Issue (8): 761-765.doi: 10.3969/j.issn.1000-6621.2021.08.002

世界卫生组织《关于更新使用结核分枝杆菌及其耐药性核酸扩增检测技术的建议》的启示

夏辉, 赵雁林()

102206 北京,中国疾病预防控制中心结核病预防控制中心

收稿日期:2021-04-30 出版日期:2021-08-10 发布日期:2021-07-30
通信作者: 赵雁林 E-mail:zhaoyl@chinacdc.cn
基金资助:
中国疾病预防控制中心课题结余资金(59911916)

Inspiration of the WHO Updated on the use of nucleic acid amplification tests to detect TB and drug-resistant TB: rapid communication

XIA Hui, ZHAO Yan-lin()

National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China

Received:2021-04-30 Online:2021-08-10 Published:2021-07-30
Contact: ZHAO Yan-lin E-mail:zhaoyl@chinacdc.cn

摘要/Abstract

摘要：

快速并准确诊断结核病及耐药结核病对于结核病防治至关重要。世界卫生组织于2021年2月18日发布了《关于更新使用结核分枝杆菌及其耐药性核酸扩增检测技术的建议》。笔者对其更新的技术及技术指标进行描述和分析,并就此背景下对中国结核病防治规划实施中相关领域可汲取的经验、潜在影响及实施层面的问题和启示进行阐述。

关键词: 分枝杆菌,结核, 核酸扩增技术, 抗药性,细菌

Abstract:

Rapid and accurate diagnosis of tuberculosis and drug-resistant tuberculosis is essential to tuberculosis prevention and control. The World Health Organization issued the Update on the use of nucleic acid amplification tests to detect TB and drug-resistant TB: rapid communication in February 18th 2021. This inspiration provided an interpretation of detailed introduction of the technologies and their technical performance, and elaborated the experience, potential effects on the current national tuberculosis control program and implementation considerations of these technologies.

Key words: Mycobacterium tuberculosis, Nucleic acid amplification techniques, Drug resistance,bacterial

夏辉, 赵雁林. 世界卫生组织《关于更新使用结核分枝杆菌及其耐药性核酸扩增检测技术的建议》的启示[J]. 中国防痨杂志, 2021, 43(8): 761-765. doi: 10.3969/j.issn.1000-6621.2021.08.002

XIA Hui, ZHAO Yan-lin. Inspiration of the WHO Updated on the use of nucleic acid amplification tests to detect TB and drug-resistant TB: rapid communication[J]. Chinese Journal of Antituberculosis, 2021, 43(8): 761-765. doi: 10.3969/j.issn.1000-6621.2021.08.002

图/表 1

参考文献 11

[1]	World Health Organization. Update on the use of nucleic acid amplification tests to detect TB and drug-resistant TB: rapid communication. Geneva: World Health Organization, 2021.
[2]	World Health Organization. WHO consolidated guidelines on tuberculosis. Module 3: diagnosis-rapid diagnostics for tuberculosis detection. Geneva: World Health Organization, 2020.
[3]	World Health Organization. Meeting report of the WHO expert consultation on the definition of extensively drug-resistant tuberculosis, 27-29 October 2020. Geneva: World Health Organization, 2021.
[4]	de Vos M, Scott L, David A, et al. Comparative Analytical Evaluation of Four Centralized Platforms for the Detection of Mycobacterium tuberculosis Complex and Resistance to Rifampicin and Isoniazid. J Clin Microbiol, 2021, 59(3):02168-20. doi: 10.1128/JCM.02168-20.
[5]	Migliori GB, Lange C, Girardi E, et al. Fluoroquinolones: are they essential to treat multidrug-resistant tuberculosis? Eur Respir J, 2008, 31(4):904-905. doi: 10.1183/09031936.00159807. doi: 10.1183/09031936.00159807 URL
[6]	Tweed CD, Dawson R, Burger DA, et al. Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide during the first 8 weeks of treatment of patients with drug-susceptible or drug-resistant pulmonary tuberculosis:a multicentre,open-label,partially randomised,phase 2b trial. Lancet Respir Med, 2019, 7(12):1048-1058. doi: 10.1016/S2213-2600(19)30366-2. doi: 10.1016/S2213-2600(19)30366-2 URL
[7]	World Health Organization. WHO Consolidated Guidelines on Drug-resistant Tuberculosis Treatment. Geneva: World Health Organization, 2010.
[8]	Bainomugisa A, Gilpin C, Coulter C, et al. New Xpert MTB/XDR: added value and future in the field. Eur Respir J, 2020, 56(5):2003616. doi: 10.1183/13993003.03616-2020. doi: 10.1183/13993003.03616-2020 URL
[9]	Cao Y, Parmar H, Gaur RL, et al. Xpert MTB/XDR: a 10-Color Reflex Assay Suitable for Point-of-Care Settings To Detect Isoniazid-,Fluoroquinolone,and Second-Line-Injectable Drug-Resistance Directly from Mycobacterium tuberculosis-Positive Sputum. J Clin Microbiol, 2021, 59(3):02314-20. doi: 10.1128/JCM.02314-20.
[10]	Xie YL, Chakravorty S, Armstrong DT, et al. Evaluation of a Rapid Molecular Drug-Susceptibility Test for Tuberculosis. N Engl J Med, 2017, 377(11):1043-1054. doi: 10.1056/NEJMoa1614915. doi: 10.1056/NEJMoa1614915 URL
[11]	Sanchez-Padilla E, Merker M, Beckert P, et al. Detection of drug-resistant tuberculosis by xpert MTB/RIF in Swaziland. N Engl J Med, 2015, 372(12):1181-1182. doi: 10.1056/NEJMc1413930. doi: 10.1056/NEJMc1413930 URL

项目	罗氏	碧迪	海恩生命科学	雅培
最大样本处理量/批次	94	24	94	94
灭活步骤	2:1 MIS^a,涡旋30~60s	2:1 Max STR^a,振荡10次,孵育5min,振荡10次	2:1液化,涡旋	3:1 IR^a,颠倒几次,涡旋20~30s
灭活孵育时间	1h	25min	30min	1h,在20min时涡旋振荡20~30s
是否需要超声	每份标本超声1min, 离心60s	否	否	否
DNA提取、扩增及检测	2h 30min报告结果	3h 41min报告结果	提取DNA 2h,封板后转移至扩增仪, 1h 41min后报告结果	提取DNA 4h 22min, 封板转移至扩增仪,2h 30min后报告结果
MTBC检测靶标	16S rRNA,esxJ,esxK,esxM,esxP,esxW	IS6110,IS1081,devR	rpoB	Pab,IS6110

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世界卫生组织《关于更新使用结核分枝杆菌及其耐药性核酸扩增检测技术的建议》的启示

Inspiration of the WHO Updated on the use of nucleic acid amplification tests to detect TB and drug-resistant TB: rapid communication

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