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

摘要 生物标志物确认是一个过程，通过该过程检测生物标志物的分析和临床性能， 确定其对特定使用环境（COU）的适用性。疟疾药物、疫苗和 其他治疗受益于高质量的诊断，但许多现有的诊断方式， 快速诊断测试和厚血涂片显微术相对不敏感和/或依赖于操作者。 相反，恶性疟原虫的分子诊断生物标志物检测已被证明是有效的。 在许多情况下具有分析和临床敏感性和特异性。在本项目中，生物标志物检测将 在疟疾流行地点进行的人类疟疾感染控制研究的档案样本上进行， 这些数据将用于支持扩大恶性疟原虫18 S rRNA的使用范围 在疟疾流行地区进行这些类型的挑战研究的生物标志物。

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.