Tuberculosis Diagnostics in 2015: Landscape, Priorities, Needs, and Prospects
Tuberculosis Diagnostics in 2015: Landscape, Priorities, Needs, and Prospects
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DOI：
10.1093/infdis/jiu803
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发表时间：
2015-04-01
影响因子：
6.4
通讯作者：
Schito, Marco
中科院分区：
文献类型：
--
作者：
Pai, Madhukar;Schito, Marco
2015年，结核病仍然是一个主要的全球健康问题，耐药结核病是一个日益严重的威胁。尽管许多国家的结核病诊断仍然依赖于旧的工具，但新的诊断方法正在改变这一局面。在Xpert MTB/RIF的成功和推出的部分刺激下，现在对新技术的兴趣相当大。前景看起来很有希望，有一个强大的新工具管道，特别是分子诊断，以及50多家公司积极参与产品开发。然而，新的诊断方法尚未达到规模，诊断方法的开发和较短疗程结核病药物治疗方案的开发之间需要更大程度的趋同。另一个令人担忧的问题是，在儿童的管道中相对缺乏非痰基诊断和生物标志物测试，用于分类，治愈和潜伏性结核分枝杆菌感染的进展。本补编中所述的几项举措已经启动，以进一步刺激产品开发和政策，包括评估需求和优先事项，开发目标产品概况，汇编耐药相关突变数据，以及评估市场规模和新诊断的潜力。需要开展宣传以增加结核病研究和开发的资金，高负担国家的政府必须在结核病控制方面投入更多资金，以实现2015年后的护理、控制和预防目标。
In 2015, tuberculosis remains a major global health problem, and drug-resistant tuberculosis is a growing threat. Although tuberculosis diagnosis in many countries is still reliant on older tools, new diagnostics are changing the landscape. Stimulated, in part, by the success and roll out of Xpert MTB/RIF, there is now considerable interest in new technologies. The landscape looks promising, with a robust pipeline of new tools, particularly molecular diagnostics, and well over 50 companies actively engaged in product development. However, new diagnostics are yet to reach scale, and there needs to be greater convergence between diagnostics development and development of shorter-duration tuberculosis drug regimens. Another concern is the relative absence of non-sputum-based diagnostics in the pipeline for children and of biomarker tests for triage, cure, and progression of latent Mycobacterium tuberculosis infection. Several initiatives, described in this supplement, have been launched to further stimulate product development and policy, including assessment of needs and priorities, development of target product profiles, compilation of data on resistance-associated mutations, and assessment of market size and potential for new diagnostics. Advocacy is needed to increase funding for tuberculosis research and development, and governments in high-burden countries must invest more in tuberculosis control to meet post-2015 targets for care, control, and prevention.