DDT-BMQ-0000107 Qualification of the Plasmodium falciparum 18S rRNA biomarker for malaria field studies

摘要 生物标记物鉴定是对生物标记物的分析和临床表现进行测试的过程 确定其是否适用于特定的使用环境(CUU)。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，但许多现有的诊断模式，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记物检测已被证明是 在许多情况下，分析和临床上的敏感性和特异性。在这个项目中，生物标记物检测将是 对疟疾流行现场临床试验的档案样本执行，数据将用于支持 恶性疟原虫18S rRNA生物标志物在疟疾流行领域的扩展使用范围 学习。

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 malaria endemic site clinical trials and the data will be utilized to support an expanded Context of Use for the Plasmodium falciparum 18S rRNA biomarker for malaria-endemic field studies.