目标产品简介:用于结核病治疗,监测和优化治疗的测试
Ankur Gupta-Wright1, Saskia den Boon2, Emily L MacLean3
1Heidelberg University Hospital, German Center of Infection Research, Heidelberg, Germany.
Bulletin of the World Health Organization
|November 14, 2023
概括
世界卫生组织 (WHO) 制定了结核病测试的目标产品概况. 这些概况指导开发准确,可访问的诊断工具,用于治疗监测和治疗评估.
科学领域:
- 全球健康 全球健康
- 传染性疾病 传染性疾病
- 医学诊断 医学诊断 医学诊断
背景情况:
- 结核病 (TB) 治疗监测和优化需要准确的诊断工具.
- 现有的诊断方法可能无法满足对有效结核病管理的需求.
- 世界卫生组织 (WHO) 发起了目标产品简介 (TPP) 的制定,以解决这些差距.
研究的目的:
- 确定结核病治疗监测和优化测试的关键特征的最低和最佳目标.
- 引导开发用于结核病治疗和治愈评估的新诊断测试.
- 确保新的结核病测试在全球范围内准确,可访问和负担得起.
主要方法:
- 利益相关者调查和成本效益和患者护理途径的分析为TPP的发展提供了信息.
- 一个类似于德尔菲的过程,技术商和公众评论期间收集了更多的利益相关者的反.
- 一个科学开发小组就最终的TPP目标达成共识.
主要成果:
- 关键的TPP特征包括高诊断准确度 (灵敏度和特异性).
- 快速获得结果的时间 (理想情况下≤2小时,最大1天) 是至关重要的.
- 最好采用轻微侵入性,易于获取的样本 (例如尿液,呼吸,毛细血管血液).
- 测试应该可以在没有实验室的边缘卫生设施中使用,并且低收入和中等收入国家可以负担得起.
- 公平的准入和扩大规模是必不可少的.
结论:
- 开发的TPP为推进结核病诊断提供了一个框架.
- 这些概况将有助于为所有结核病患者创建准确和可访问的测试.
- 通过更好的监测和优化,TPP旨在改善全球结核病治疗结果.
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