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首页> 外文期刊>Journal of applied toxicology >The within‐ and between‐laboratory reproducibility and predictive capacity of the in chemico amino acid derivative reactivity assay: Results of validation study implemented in four participating laboratories
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The within‐ and between‐laboratory reproducibility and predictive capacity of the in chemico amino acid derivative reactivity assay: Results of validation study implemented in four participating laboratories

机译：化学氨基酸衍生物反应性测定的实验室再现性和实验室之间的预测能力：在四个参与实验室实施的验证研究结果

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摘要

The amino acid derivative reactivity assay (ADRA) is an in chemico alternative method that focuses on protein binding as the molecular initiating event for skin sensitization. It is a simple and versatile method that has successfully solved some of the problems of the direct peptide reactivity assay (DPRA). The transferability and within‐ and between‐laboratory reproducibility of ADRA were evaluated and confirmed as part of a validation study conducted at four participating laboratories. The transfer of ADRA technology from the lead laboratory to the four participating laboratories was completed successfully during a two‐step training program, after which the skin sensitization potentials of 40 coded chemicals were predicted based on the results of ADRA testing. Within‐laboratories reproducibility was 100% (10 of 10), 100% (10 of 10), 100% (7 of 7) and 90% (9 of 10), or an average of 97.3% (36 of 37); between‐laboratory reproducibility as calculated on the results of three laboratories at the time was 91.9%. The overall predictive capacity comprised an accuracy of 86.9%, sensitivity of 81.5% and specificity of 98.1%. These results satisfied the targets set by the validation management team for demonstrating transferability, within‐ and between‐laboratory reproducibility, and predictive capacity as well as gave a clear indication that ADRA is easily transferable and sufficiently robust to be used in place of DPRA.
机译：氨基酸衍生物反应性测定法（ADRA）是在化学替代方法中，侧重于蛋白质结合作为皮肤致敏的分子引发事件。这是一种简单而多功能的方法，已成功解决了直接肽反应性测定（DPRA）的一些问题。根据四项参与实验室进行的验证研究的一部分，评估和确认ADRA的可转移和在实验室内和之间的实验室再现性。在两步培训计划期间成功完成了从铅实验室到四个参与实验室的铅实验室转移，之后，基于ADRA测试的结果预测了40种编码化学品的皮肤致敏电位。实验室内的再现性为100％（10个），100％（10个），100％（7个）和90％（共10个中的10个），或平均为97.3％（37个）;在实验室之间的再现性，按照三个实验室的结果计算为91.9％。整体预测能力占86.9％，敏感性为81.5％，特异性为98.1％。这些结果满足了验证管理团队设定的目标，以证明实验室和实验室之间的可重复性，以及预测性能，并清楚地表明ADRA易于转移，以用于代替DPRA。

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