毒症诊断的目标产品概况:为诊断创新提出一种新方法

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Monica Sharma¹, Meenu Jain², Balaji Veeraraghavan³

¹Division of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi, India.

The Indian journal of medical research

|June 16, 2023

概括

在印度开发用于败血症的快速诊断是至关重要的. 本研究定义了毒症和新生儿毒症查和诊断的目标产品配置文件 (TPP),旨在提供更快,更实惠和更有效的解决方案.

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:

败血症,包括新生儿败血症,是印度等低收入和中等收入国家的主要死亡原因.
非特异性症状和缺乏快速测试阻碍了早期诊断和治疗.
迫切需要负担得起,快速转折的诊断.

研究的目的:

定义用于快速败血症诊断的目标产品配置文件 (TPP) 的标准.
建立对开发诊断测试的基本特征的共识.
引导创建"适合使用"的血症和新生儿血症诊断工具.

主要方法:

采用了三轮的Delphi方法,包括在线调查和虚拟咨询.
由23名专家组成的专家小组做出了贡献,包括传染病医生和技术创新者.
在诊断TPP的最低和最佳属性上建立了共识.

主要成果:

建立了用于败血症诊断的三组分产品概况:高灵敏性查,病因性病原体检测和抗菌素耐药性概况.
该TPP涵盖成人和新生儿败血症,有各种测试考虑的选择.
在TPP的所有特征上达成75%以上的协议,这些特征是针对印度医疗保健环境量身定制的.

结论:

开发的TPP为印度和类似资源有限的环境中的诊断开发人员提供了关键的指导.
基于这些 TPP 实施基于这些 TPP 的诊断可以提高资源利用率并加速产品开发.
这些进展旨在减少患者的经济负担,并通过更好的败血症管理来挽救生命.

关键词:

抗生素抗生素是一种抗生素.印度印度印度抗微生物耐药性抗微生物耐药性这是一个有特点的特征.诊断诊断诊断诊断诊断新生儿败血症新生儿败血症这是一种血症.目标产品简介测试测试目标产品简介测试

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