Me-too validation study for in vitro skin irritation test with a reconstructed human epidermis model, KeraSkin™ for OECD test guideline 439
Me-too validation study for in vitro skin irritation test with a reconstructed human epidermis model, KeraSkin™ for OECD test guideline 439
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DOI：
10.1016/j.yrtph.2020.104725
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发表时间：
2020-11-01
影响因子：
3.4
通讯作者：
Lim, Kyung-Min
中科院分区：
文献类型：
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作者：
Han, Juhee;Kim, Seolyeong;Lim, Kyung-Min
我们进行了一项模拟验证研究，以确认KeraSkin(TM)皮肤刺激试验(SIT)作为OECD TG 439模拟方法的重复性、可靠性和预测能力。在20种参考化学品中，KeraSkin(TM)的实验室内重复性(WLR)对刺激性或非刺激性的判断分别为100%、100%和95%，而实验室间重复性(BLR)为100%，满足性能标准(PS，WLR和Gt；=90%，BLR和Gt；=80%)的标准。WLR和BLR通过组内相关性得到进一步确认(ICC，系数>；0.950)。用散点图和Bland-Altman图显示原始数据中的WLR和BLR(生存能力)。与现有的Bland-Altman图、ICC和Kappa统计的VRM进行比较，证实了KeraSkin(TM)SIT与OECD TG 439的兼容性。用20种参考化学物质(敏感性为98.9%，特异性为70%，准确性为84.4%)和另外46种化学物质(对于66种化学物质[20+46种化学物质，敏感性、特异性和准确性分别为95.2%、82.2%和86.4%])来评估KeraSkin(TM)SIT的预测能力。受试者工作特性(ROC)分析表明，当改变截止值(50%-60-75%)时，预测能力有潜在的改善，尤其是灵敏度。总而言之，模拟价值研究表明，KeraSkin(TM)SIT可以成为OECD TG 439的一种新的模拟方法。
We conducted a me-too validation study to confirm the reproducibility, reliability, and predictive capacity of KeraSkin (TM) skin irritation test (SIT) as a me-too method of OECD TG 439. With 20 reference chemicals, within-laboratory reproducibility (WLR) of KeraSkin (TM) SIT in the decision of irritant or non-irritant was 100%, 100%, and 95% while between-laboratory reproducibility (BLR) was 100%, which met the criteria of performance standard (PS, WLR >= 90%, BLR >= 80%). WLR and BLR were further confirmed with intra-class correlation (ICC, coefficients >0.950). WLR and BLR in raw data (viability) were also shown with a scatter plot and Bland-Altman plot. Comparison with existing VRMs with Bland-Altman plot, ICC and kappa statistics confirmed the compatibility of KeraSkin (TM) SIT with OECD TG 439. The predictive capacity of KeraSkin (TM) SIT was estimated with 20 reference chemicals (the sensitivity of 98.9%, the specificity of 70%, and the accuracy of 84.4%) and additional 46 chemicals (for 66 chemicals [20 + 46 chemicals, the sensitivity, specificity and accuracy: 95.2%, 82.2% and 86.4%]). The receiver operating characteristic (ROC) analysis suggested a potential improvement of the pre dictive capacity, especially sensitivity, when changing cut-off (50% -> 60-75%). Collectively, the me-too vali dation study demonstrated that KeraSkin (TM) SIT can be a new me-too method for OECD TG 439.