Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test.
Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test.
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结核病诊断的进展：XPERT MTB/RIF分析和未来的预期测试。
DOI：
10.1016/s1473-3099(13)70008-2
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发表时间：
2013-04
期刊：
影响因子：
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通讯作者：
Zumla A
中科院分区：
文献类型：
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作者：
Lawn SD;Mwaba P;Bates M;Piatek A;Alexander H;Marais BJ;Cuevas LE;McHugh TD;Zijenah L;Kapata N;Abubakar I;McNerney R;Hoelscher M;Memish ZA;Migliori GB;Kim P;Maeurer M;Schito M;Zumla A
近年来，结核病新诊断方法的开发取得了快速进展。已经开发和评估了新技术，现在正在实施。2010年12月，世卫组织批准了Xpert MTB/RIF试验，该方法能够同时检测结核分枝杆菌(MTB)和利福平(RIF)耐药性。该检测被特别推荐用于疑似耐药或HIV相关肺结核的初步诊断试验。截至2012年6月，三分之二结核病负担高的国家和一半耐多药结核病负担高的国家已将该检测纳入其国家结核病规划指南。尽管Xpert MTB/RIF试验的发展无疑是一个里程碑式的事件，但临床和计划效果以及成本效益仍有待确定。我们回顾了迅速增长的科学文献，并讨论了在结核病流行地区使用Xpert MTB/RIF检测的优势和挑战。我们还回顾了发展管道中的其他前景。迫切需要一种负担得起且易于实施的快速、准确的医疗保健点诊断测试。对结核病诊断管道的投资应该仍然是资助者和研究人员的主要优先事项。
Rapid progress has been made in the development of new diagnostic assays for tuberculosis in recent years. New technologies have been developed and assessed, and are now being implemented. The Xpert MTB/RIF assay, which enables simultaneous detection of Mycobacterium tuberculosis (MTB) and rifampicin (RIF) resistance, was endorsed by WHO in December, 2010. This assay was specifically recommended for use as the initial diagnostic test for suspected drug-resistant or HIV-associated pulmonary tuberculosis. By June, 2012, two-thirds of countries with a high tuberculosis burden and half of countries with a high multidrug-resistant tuberculosis burden had incorporated the assay into their national tuberculosis programme guidelines. Although the development of the Xpert MTB/RIF assay is undoubtedly a landmark event, clinical and programmatic effects and cost-effectiveness remain to be defined. We review the rapidly growing body of scientific literature and discuss the advantages and challenges of using the Xpert MTB/RIF assay in areas where tuberculosis is endemic. We also review other prospects within the developmental pipeline. A rapid, accurate point-of-care diagnostic test that is affordable and can be readily implemented is urgently needed. Investment in the tuberculosis diagnostics pipeline should remain a major priority for funders and researchers.