Development, roll-out and impact of Xpert MTB/RIF for tuberculosis: what lessons have we learnt and how can we do better?
Development, roll-out and impact of Xpert MTB/RIF for tuberculosis: what lessons have we learnt and how can we do better?
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DOI：
10.1183/13993003.00543-2016
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发表时间：
2016-08
期刊：
影响因子：
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通讯作者：
Boehme CC
中科院分区：
文献类型：
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作者：
Albert H;Nathavitharana RR;Isaacs C;Pai M;Denkinger CM;Boehme CC
Xpert MTB/RIF （Cepheid Inc., Sunnyvale， CA， USA）的全球推广改变了结核病的诊断格局。自2011年以来，在122个国家进行了1600多万次检测，与传统检测相比，耐多药结核病的检测增加了3至8倍。这一举措激励了从捐助者到民间社会的利益攸关方，并为普及药物敏感性测试铺平了道路。它吸引了结核病新产品开发人员，从而形成了一个强大的分子诊断管道。然而，该计划的推出也突显出制约扩大规模和对患者预后影响有限的差距。由于资金不足的方案费用高昂、没有一整套解决办法（特别是全面培训、质量保证、执行计划、服务和维修支助不足）以及缺乏影响评估，推广工作受到阻碍。对与确诊患者护理的有效联系给予的重视不够，薄弱的卫生系统削弱了临床影响。在许多国家，私营部门在结核病控制方面发挥主导作用，但该部门获得补贴定价的机会有限。根据这些经验教训，我们主张采取全面的诊断实施方法，包括加强国内利益攸关方参与产品发布和推广，在准备新技术方面更广泛地加强系统，以及从规划环境中获得高质量的影响数据。包括加强系统在内的综合诊断解决办法对结核病诊断影响至关重要http://ow.ly/uWSy300CfJT
The global roll-out of Xpert MTB/RIF (Cepheid Inc., Sunnyvale, CA, USA) has changed the diagnostic landscape of tuberculosis (TB). More than 16 million tests have been performed in 122 countries since 2011, and detection of multidrug-resistant TB has increased three- to eight-fold compared to conventional testing. The roll-out has galvanised stakeholders, from donors to civil society, and paved the way for universal drug susceptibility testing. It has attracted new product developers to TB, resulting in a robust molecular diagnostics pipeline. However, the roll-out has also highlighted gaps that have constrained scale-up and limited impact on patient outcomes. The roll-out has been hampered by high costs for under-funded programmes, unavailability of a complete solution package (notably comprehensive training, quality assurance, implementation plans, inadequate service and maintenance support) and lack of impact assessment. Insufficient focus has been afforded to effective linkage to care of diagnosed patients, and clinical impact has been blunted by weak health systems. In many countries the private sector plays a dominant role in TB control, yet this sector has limited access to subsidised pricing. In light of these lessons, we advocate for a comprehensive diagnostics implementation approach, including increased engagement of in-country stakeholders for product launch and roll-out, broader systems strengthening in preparation for new technologies, as well as quality impact data from programmatic settings. A comprehensive diagnostic solution approach including systems strengthening is essential for TB diagnostics impact http://ow.ly/uWSy300CfJT