Abstract

Radiation Biodosimetry is a continually developing clinical diagnostic field, which focuses on biological markers that proportionally change in relationship to the amount of ionizing radiation absorbed. Examples of host marker response include changes in white cell count, specific proteins in circulation, RNAs in white blood cells, or chromosome fidelity in affected lymphocytes. Measurements of radiation biomarkers correlate with the approximate radiation dose absorbed and indirectly provide an assessment of the likelihood of developing acute radiation syndrome. The aim of this review is to summarize four biodosimetry programs that are in advanced development, later pipeline stages with funding from the Biomedical Advanced Research and Development Authority (BARDA), an agency under the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS). With BARDA financial support, biodosimetry diagnostic assays in development will inform patient management, improve health and psychosocial outcomes, and save lives after a nuclear disaster. These tests include an SRI International developed rapid on-site screening test requiring only a finger stick of blood to triage those who have received little or no radiation from those who have received clinically significant levels of radiation and need further immediate patient management. In addition, multiple laboratory-based, high-throughput quantitative tests, currently under development by MRIGlobal, DxTerity, and ASELL, will more accurately define dose levels and possibly predict cellular and organ-damage and other longer-term effects of radiation. In the future, when clinical and analytical validation of these assays is complete, the data is reviewed by the FDA, and agency use status is obtained, rapid triage and laboratory-based biodosimetry test results will enable emergency medical teams to do the most good for the largest number of people after a nuclear blast.

摘要

辐射生物剂量学是一个不断发展的临床诊断领域，它专注于与吸收的电离辐射量成比例变化的生物标志物。宿主标记反应的例子包括白细胞计数的变化、循环中的特定蛋白质、白细胞中的 RNA 或受影响淋巴细胞中的染色体保真度。辐射生物标志物的测量与吸收的近似辐射剂量相关，并间接提供了对发展为急性辐射综合征的可能性的评估。本次审查的目的是总结四个处于高级开发阶段的生物剂量测定计划，后期管道阶段由生物医学高级研究与发展局 (BARDA) 资助，隶属于美国卫生与公众服务部 (HHS) 备灾和响应助理部长 (ASPR) 的机构。在 BARDA 的财政支持下，开发中的生物剂量学诊断分析将为患者管理提供信息，改善健康和社会心理结果，并在核灾难后挽救生命。这些测试包括 SRI International 开发的快速现场筛查测试，只需要一根手指抽血即可对那些接受过很少或没有接受过辐射的人与接受过临床显着水平辐射并需要进一步立即患者管理的人进行分类。此外，MRIGlobal、DxTerity 和 ASELL 目前正在开发多项基于实验室的高通量定量测试，将更准确地定义剂量水平，并可能预测细胞和器官损伤以及辐射的其他长期影响。将来，当这些检测方法的临床和分析验证完成、数据由 FDA 审查并获得机构使用状态时，快速分流和基于实验室的生物剂量学检测结果将使紧急医疗团队能够为核爆炸后人数最多的。