Abstract：
A novel in vitro 3D micronucleus assay was developed in China using the EpiSkin™ 3D human skin model. This EpiSkin™ Micronucleus Assay showed good predictivity and reproducibility during internal validation and is expected to contribute to in vitro genotoxicity testing as a follow-up for positive results from 2D micronucleus assay. Having developed the assay in one laboratory, further work focused on the transferability and inter-laboratory reproducibility in two additional Chinese authority laboratories (Guangdong Provincial Center for Disease Control and Prevention and Zhejiang Institute for Food and Drug Control). Formal training was provided for both laboratories, which resulted in good transferability based on the results of two positive compounds, such as mitomycin C and vinblastine. Independent experiments were then performed, and inter-laboratory reproducibility was checked using 2-acetylaminofluorene, 5-fluorouracil, 2,4-dichlorophenol, and d-limonene. The dose-responses of the positive control chemical, mitomycin C, were similar to those of the developing laboratory, and all test chemicals were correctly classified by all laboratories. Overall, there was a good transferability as well as intra- and inter-laboratory reproducibility of the EpiSkin™ Micronucleus Assay. This study further confirmed the assay\'s robustness and provided confidence to enter following validation stages for scientific acceptance.
摘要：
在中国使用EpiSkin™3D人类皮肤模型开发了一种新型的体外3D微核测定法。该EpiSkin™微核测定在内部验证期间显示出良好的预测性和可重复性,并且预期作为来自2D微核测定的阳性结果的后续行动有助于体外遗传毒性测试。在一个实验室开发了该检测方法后，进一步的工作重点是在另外两个中国权威实验室（广东省疾病预防控制中心和浙江省食品药品检验所）的可转移性和实验室间的可重复性。为两个实验室提供了正式培训，基于两个阳性化合物的结果，这导致了良好的可转移性，如丝裂霉素C和长春碱。然后进行独立实验，并使用2-乙酰氨基芴检查实验室间的再现性，5-氟尿嘧啶,2,4-二氯苯酚,和d-柠檬烯.阳性对照化学品的剂量反应，丝裂霉素C,与正在开发的实验室相似，所有测试化学品都被所有实验室正确分类。总的来说,EpiSkin™微核试验具有良好的可转移性以及实验室内和实验室间的可重复性.这项研究进一步证实了该测定的稳健性，并为进入以下验证阶段提供了信心，以进行科学接受。
