Wageningen University, Environmental Economics and Natural Resources Management Group, Wageningen, The Netherlands.
current address: Triskelion B.V., Zeist, The Netherlands.
ALTEX. 2019;36(3):435-446. doi: 10.14573/altex.1810111. Epub 2019 Apr 5.
The ability of non-animal methods to correctly predict the outcome of in vivo testing in repeated applications is referred to as precision. Due to dichotomising continuous read-outs into discrete "positive/negative" hazard data, non-animal methods can reveal discordant classifications if results are sufficiently close to a defined classification threshold. This paper explores the impact of precision uncertainty on the predictive accuracy of non-animal methods. Using selected non-animal methods for assessing skin sensitisation hazard as case study examples, we explore the impact of precision uncertainty separately and in combination with uncertainty due to varying composition and size of experimental samples. Our results underline that discrete numbers of non-animal methods' sensitivity, specificity and concordance are of limited information for evaluations of non-animal testing methods' predictivity. Instead, information on the variability, and the upper and lower limits of accuracy metrics, should be provided to ensure a transparent assessment of testing methods' predictivity, and to allow for a meaningful comparison of the predictivity of non-animal methods with that of animal tests.
非动物方法在反复应用中正确预测体内测试结果的能力被称为精确性。由于将连续的读数离散化为“阳性/阴性”危险数据，因此如果结果足够接近定义的分类阈值，非动物方法可能会揭示出不一致的分类。本文探讨了精度不确定性对非动物方法预测准确性的影响。使用选择的非动物方法评估皮肤致敏危险作为案例研究示例，我们分别探讨了精度不确定性以及由于实验样本的组成和大小变化而产生的不确定性的影响。我们的结果强调，非动物方法的敏感性、特异性和一致性的离散数量对于非动物测试方法的预测性评估信息量有限。相反，应该提供有关变异性以及准确性度量的上限和下限的信息，以确保对测试方法的预测性进行透明评估，并允许对非动物方法与动物测试的预测性进行有意义的比较。
