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针对AMR诊断测试的目标产品配置文件开发的专家指导

Till T Bachmann¹, Konstantinos Mitsakakis^2,3, John P Hays⁴

¹Center for Inflammation Research, University of Edinburgh, Edinburgh, UK till.bachmann@ed.ac.uk.

BMJ global health

|December 19, 2023

概括

开发新的抗菌素耐药性 (AMR) 诊断方法需要了解目标产品 (TPP) 特性如何相互影响. 本指南有助于优先考虑功能,以便更有效地开发关键的AMR诊断测试.

科学领域:

医学诊断医学诊断医学诊断
传染病研究传染病研究
公共卫生公共卫生

背景情况:

抗菌素耐药性 (AMR) 构成了全球健康的重大威胁,预计到2030年每年会造成1000万人的死亡.
对于AMR诊断的需求与其实际的开发和实施之间存在着关键的差距.
目标产品配置文件 (TPP) 指导AMR诊断测试的开发,但它们的有效性可以提高.

研究的目的:

通过结合关键发展特征之间的相互依赖,扩展现有的与抗菌耐药性相关的TPP.
识别和绘制TPP六大类的46个特征之间的相互依赖关系.
为利益相关者提供有关优先考虑TPP特征的见解,以有效开发AMR诊断.

主要方法:

会议召开了一个由来自工业,学术界和医疗保健领域的51名国际专家组成的多部门工作组.
确定了46个特征,并分为六个主要领域:预期使用,诊断问题,测试描述,测试协议,性能和商业性.
绘制了这些特征之间的相互依赖关系,以揭示它们对彼此的影响.

主要成果:

该研究确定并绘制了46个关键特征之间的相互依赖关系,这些特征对于AMR诊断发展至关重要.
人们认识到,为开发商同时实现所有TPP建议可能是不可行的.
在诊断开发过程中,提供了关于优先考虑特定TPP特征如何影响其他特征的指导.

结论:

了解TPP内部的相互依存关系对于优化AMR诊断开发至关重要.
优先考虑特定的TPP特征可以导致更有效的发展途径.
这项工作为利益相关者提供了指导,以便更有效地开发抗菌耐药性诊断,弥合需求和实施之间的差距.

关键词:

诊断和工具和工具.感染,疾病,疾病,损伤,伤害.公共卫生公共卫生.

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