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在扩大使用Xpert MTB/RIF检测方法的过程中,津巴布韦对复治结核病患者的分枝杆菌培养及药敏试验系统的运行情况如何?

How has the Zimbabwe mycobacterial culture and drug sensitivity testing system among re-treatment tuberculosis patients functioned during the scale-up of the Xpert MTB/RIF assay?

作者信息

Timire Collins, Takarinda Kudakwashe C, Harries Anthony D, Mutunzi Herbert, Manyame-Murwira Barbara, Kumar Ajay M V, Sandy Charles

机构信息

International Union Against Tuberculosis and Lung Disease (The Union), 13 Van Praagh Av, Milton Park, Harare, Zimbabwe.

The Union, 68 Boulevard St Michel, Paris, France.

出版信息

Trans R Soc Trop Med Hyg. 2018 Jun 1;112(6):285-293. doi: 10.1093/trstmh/try054.

DOI:10.1093/trstmh/try054
PMID:29992299
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6044330/
Abstract

BACKGROUND

In Zimbabwe, while the Xpert MTB/RIF assay is being used for diagnosing tuberculosis and rifampicin-resistance, re-treatment tuberculosis (TB) patients are still expected to have culture and drug sensitivity testing (CDST) performed at national reference laboratories for confirmation. The study aim was to document the Xpert MTB/RIF assay scale-up and assess how the CDST system functioned for re-treatment TB patients.

METHODS

We performed an ecologic study using national aggregate data.

RESULTS

Use of the Xpert MTB/RIF assay increased from 11 829 to 68 153 between 2012 and 2016. Xpert assays worked well, with successful tests in more than 90% of cases, TB detection rates at 15-17% and rifampicin resistance in <10%. During Xpert scale-up, the number of sputum specimens from re-treatment TB patients reaching national reference laboratories for CDST increased from 12% to 51%. In terms of laboratory performance, culture contamination increased from 3% to 17%, positive cultures from 13% to 17% and successful CDST from 6% to 14%: the proportion of CDST showing any resistance to rifampicin averaged 44%. From 2009 to 2016, the proportion of notified re-treatment TB patients with successful CDST increased from <1% to 7%.

CONCLUSIONS

While components of Zimbabwe's CDST system for re-treatment TB patients showed some changes during the scale-up of the Xpert MTB/RIF assay, overall performance was poor. The country must either invest in improving CDST performance or in advanced molecular diagnostic technology.

摘要

背景

在津巴布韦,虽然Xpert MTB/RIF检测法用于诊断结核病和利福平耐药性,但复治结核病患者仍需在国家参考实验室进行培养和药敏试验(CDST)以进行确诊。本研究的目的是记录Xpert MTB/RIF检测法的推广情况,并评估CDST系统对复治结核病患者的运作情况。

方法

我们使用国家汇总数据进行了一项生态学研究。

结果

2012年至2016年间,Xpert MTB/RIF检测法的使用量从11829例增加到68153例。Xpert检测法效果良好,超过90%的检测成功,结核病检出率为15%-17%,利福平耐药率低于10%。在Xpert检测法推广期间,送往国家参考实验室进行CDST的复治结核病患者的痰标本数量从12%增加到51%。在实验室性能方面,培养污染率从3%增加到17%,阳性培养率从13%增加到17%,成功的CDST从6%增加到14%:显示对利福平有任何耐药性的CDST比例平均为44%。从2009年到2016年,成功进行CDST的报告复治结核病患者比例从不到1%增加到7%。

结论

虽然津巴布韦复治结核病患者的CDST系统组件在Xpert MTB/RIF检测法推广期间出现了一些变化,但总体表现不佳。该国必须投资改善CDST性能或先进的分子诊断技术。

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Diagnosis and treatment of TB patients with rifampicin resistance detected using Xpert(®) MTB/RIF in Zimbabwe.
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Implementing the Xpert® MTB/RIF Diagnostic Test for Tuberculosis and Rifampicin Resistance: Outcomes and Lessons Learned in 18 Countries.实施用于结核病和利福平耐药性检测的Xpert® MTB/RIF诊断试验:18个国家的成果与经验教训
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