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RENB 实验室间比较 2017:ILCs 的局限性和缺陷。

RENEB Inter-Laboratory comparison 2017: limits and pitfalls of ILCs.

机构信息

Institut de Radioprotection et de Sûreté Nucléaire, Fontenay-aux-Roses, France.

Universitat Autonoma de Barcelona, Barcelona, Spain.

出版信息

Int J Radiat Biol. 2021;97(7):888-905. doi: 10.1080/09553002.2021.1928782. Epub 2021 May 25.

DOI:10.1080/09553002.2021.1928782
PMID:33970757
Abstract

PURPOSE

In case of a mass-casualty radiological event, there would be a need for networking to overcome surge limitations and to quickly obtain homogeneous results (reported aberration frequencies or estimated doses) among biodosimetry laboratories. These results must be consistent within such network. Inter-laboratory comparisons (ILCs) are widely accepted to achieve this homogeneity. At the European level, a great effort has been made to harmonize biological dosimetry laboratories, notably during the MULTIBIODOSE and RENEB projects. In order to continue the harmonization efforts, the RENEB consortium launched this intercomparison which is larger than the RENEB network, as it involves 38 laboratories from 21 countries. In this ILC all steps of the process were monitored, from blood shipment to dose estimation. This exercise also aimed to evaluate the statistical tools used to compare laboratory performance.

MATERIALS AND METHODS

Blood samples were irradiated at three different doses, 1.8, 0.4 and 0 Gy (samples A, C and B) with 4-MV X-rays at 0.5 Gy min, and sent to the participant laboratories. Each laboratory was requested to blindly analyze 500 cells per sample and to report the observed frequency of dicentric chromosomes per metaphase and the corresponding estimated dose.

RESULTS

This ILC demonstrates that blood samples can be successfully distributed among laboratories worldwide to perform biological dosimetry in case of a mass casualty event. Having achieved a substantial harmonization in multiple areas among the RENEB laboratories issues were identified with the available statistical tools, which are not capable to advantageously exploit the richness of results of a large ILCs. Even though - and -tests are accepted methods for biodosimetry ILCs, setting the number of analyzed metaphases to 500 and establishing a tests' common threshold for all studied doses is inappropriate for evaluating laboratory performance. Another problem highlighted by this ILC is the issue of the dose-effect curve diversity. It clearly appears that, despite the initial advantage of including the scoring specificities of each laboratory, the lack of defined criteria for assessing the robustness of each laboratory's curve is a disadvantage for the 'one curve per laboratory' model.

CONCLUSIONS

Based on our study, it seems relevant to develop tools better adapted to the collection and processing of results produced by the participant laboratories. We are confident that, after an initial harmonization phase reached by the RENEB laboratories, a new step toward a better optimization of the laboratory networks in biological dosimetry and associated ILC is on the way.

摘要

目的

在大规模放射性突发事件中,需要通过网络来克服人员过剩的限制,并快速获得生物剂量学实验室之间的同质结果(报告的染色体畸变频率或估计剂量)。这些结果必须在网络内保持一致。实验室间比较(ILC)被广泛认为是实现这一目标的方法。在欧洲层面,为了实现生物剂量学实验室的协调一致,已经做出了巨大的努力,特别是在 MULTIBIODOSE 和 RENEB 项目期间。为了继续协调一致的努力,RENEB 联盟发起了这次 ILC,其规模大于 RENEB 网络,因为它涉及来自 21 个国家的 38 个实验室。在这次 ILC 中,从血液运输到剂量估计,对整个过程的所有步骤进行了监测。此次活动还旨在评估用于比较实验室性能的统计工具。

材料和方法

血液样本在 4MV X 射线照射下,以 0.5Gy/min 的剂量分别照射 3 个不同的剂量,1.8Gy、0.4Gy 和 0Gy(样本 A、C 和 B),然后分发给参与实验室。每个实验室被要求对每个样本的 500 个细胞进行盲法分析,并报告每个中期的双着丝粒染色体的观察频率和相应的估计剂量。

结果

这次 ILC 表明,可以成功地将血液样本分发给世界各地的实验室,以便在发生大规模伤亡事件时进行生物剂量学研究。在 RENEB 实验室的多个领域实现了实质性的协调一致之后,现有的统计工具存在问题,这些工具无法充分利用大型 ILC 的丰富结果。尽管 - 和 - 检验是生物剂量学 ILC 的公认方法,但将分析的中期数量设置为 500 个,并为所有研究剂量建立检验的共同阈值,对于评估实验室的性能是不适当的。这次 ILC 还突出了另一个问题,即剂量-效应曲线多样性的问题。显然,尽管纳入每个实验室的评分特异性具有初始优势,但缺乏评估每个实验室曲线稳健性的定义标准,这对“每个实验室一条曲线”的模型不利。

结论

根据我们的研究,似乎有必要开发更适合收集和处理参与实验室产生的结果的工具。我们相信,在 RENEB 实验室完成初始协调一致阶段之后,生物剂量学和相关 ILC 实验室网络的进一步优化已经提上日程。

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