DxTerity Diagnostics, Los Angeles, CA, USA.
ClinReg Consulting Services, Inc, Laguna Beach, CA, USA.
Int J Radiat Biol. 2020 Jan;96(1):57-66. doi: 10.1080/09553002.2018.1532615. Epub 2018 Dec 3.
We introduce and evaluate a high throughput biodosimetry test system (REDI-Dx) suitable for testing of thousands of potential radiation victims following a mass scale nuclear event caused by detonation of a nuclear device or a nuclear accident, as part of an overall strategy for effective medical management of the crisis.
The performance of a high throughput biodosimetry test was evaluated by collecting samples of both non-irradiated presumed healthy donors as well as irradiated subjects collected as part of either cancer treatment regimens or banked from previous studies. The test measures the gene expression of a set of radiation responsive genes based on the DxDirect genomic platform. The potential diagnostic accuracy of REDI-Dx was evaluated as a predictor of actual dose of radiation. While the REDI-Dx test has been calibrated to provide a quantitative measure of actual absorbed dose, we compared the performance of the REDI-Dx test (sensitivity and specificity) as a qualitative result at the most commonly applied thresholds 2.0 Gy and 6.0 Gy.
The test demonstrated high specificity and lack of effect of medical conditions. Using receiver operating characteristic (ROC) curve analysis, REDI-Dx was shown to be a good predictor of actual dose for determining treatment category based on either 2.0 or 6.0 Gy, with a 98.5% sensitivity and 90% specificity for 2.0 Gy, and 92% sensitivity and 84% specificity for 6.0 Gy. Results were reproducible between clinical laboratories with an SD of 0.2 Gy for samples ≤2.0 Gy and a CV of 10.3% for samples from 2.0 to 10.0 Gy.
Use of a biodosimetry test, like REDI-Dx test system would provide valuable information that would improve the ability to assign patients to the correct treatment category when combined with currently available biodosimetry tools, as compared to the use of existing tools alone. The REDI-Dx biodosimetry test system is for investigational use only in the U.S.A. The performance characteristics of this product have not been established.
我们引入并评估了一种高通量生物剂量测定测试系统（REDI-Dx），该系统适用于在核装置爆炸或核事故引起的大规模核事件后，对数千名潜在的辐射受害者进行测试，作为有效医疗管理危机的整体策略的一部分。
通过收集未经辐照的假定健康供体的样本以及作为癌症治疗方案的一部分或从以前的研究中收集的辐照对象的样本，评估高通量生物剂量测定测试的性能。该测试基于 DxDirect 基因组平台测量一组辐射反应基因的基因表达。REDI-Dx 的潜在诊断准确性被评估为实际辐射剂量的预测因子。虽然 REDI-Dx 测试已校准为提供实际吸收剂量的定量测量，但我们比较了 REDI-Dx 测试（灵敏度和特异性）作为最常应用的 2.0Gy 和 6.0Gy 阈值的定性结果的性能。
该测试表现出高特异性和不受医疗条件影响。使用接收器操作特性（ROC）曲线分析，REDI-Dx 被证明是一种很好的实际剂量预测因子，可根据 2.0 或 6.0Gy 确定治疗类别，2.0Gy 时灵敏度为 98.5%，特异性为 90%，6.0Gy 时灵敏度为 92%，特异性为 84%。在临床实验室之间，结果具有可重复性，对于≤2.0Gy 的样本，SD 为 0.2Gy，对于 2.0 至 10.0Gy 的样本，CV 为 10.3%。
与单独使用现有工具相比，使用生物剂量测定测试（如 REDI-Dx 测试系统）将提供有价值的信息，这将提高在与当前可用的生物剂量测定工具结合使用时将患者分配到正确治疗类别的能力。REDI-Dx 生物剂量测定测试系统仅供美国研究使用。该产品的性能特征尚未确定。
