DDT-BMQ-0000100 Qualification of the Plasmodium falciparum 18S rRNA biomarker for malaria-endemic controlled human malaria infection studies

DDT-BMQ-0000100 疟疾流行控制人类疟疾感染研究中恶性疟原虫 18S rRNA 生物标志物的鉴定

• 批准号: 10836140
• 负责人: Sean C Murphy
• 金额: $ 24.92万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10836140
• 关键词: DDT; BMQ; 0000100; Qualification; Plasmodium

ABSTRACT Biomarker qualification is a process whereby the analytical and clinical performance of a biomarker is tested to determine its suitability for a particular Context of Use (COU). Clinical trials of malaria drugs, vaccines, and other therapeutics benefits from high quality diagnostics, but many of the existing diagnostic modalities such as rapid diagnostic tests and thick blood smear microscopy are relatively insensitive and/or operator-dependent. In contrast, molecular diagnostic biomarker testing for Plasmodium falciparum has been shown to be analytically and clinically sensitive and specific in many settings. In this project, biomarker testing will be performed on archival samples from controlled human malaria infection studies at malaria-endemic sites and the data will be utilized to support an expanded Context of Use for the Plasmodium falciparum 18S rRNA biomarker for these type of challenge studies in malaria-endemic regions.

抽象的 生物标志物鉴定是测试生物标志物的分析和临床性能的过程 确定其对特定使用环境 (COU) 的适用性。疟疾药物、疫苗和药物的临床试验 其他疗法受益于高质量的诊断，但许多现有的诊断方式，例如 快速诊断测试和厚血涂片显微镜相对不敏感和/或依赖于操作员。 相比之下，恶性疟原虫的分子诊断生物标志物检测已被证明是 在许多情况下具有分析和临床敏感性和特异性。在这个项目中，生物标志物测试将 对来自疟疾流行地点受控人类疟疾感染研究的档案样本进行了研究 该数据将用于支持恶性疟原虫 18S rRNA 的扩展使用范围 用于疟疾流行地区此类挑战研究的生物标志物。