评估 GARDskin 预测医疗器械材料提取物中皮肤致敏物质的适用性

IF 3.6 Q2 TOXICOLOGY Frontiers in toxicology Pub Date : 2024-03-12 DOI:10.3389/ftox.2024.1320367
Rose-Marie Jenvert, O. Larne, A. Johansson, Mattias Berglin, Emma Pedersen, Henrik Johansson
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引用次数: 0

摘要

医疗器械的生物相容性测试由 ISO 10993 系列标准规定,包括最终产品的皮肤致敏可能性评估。大部分医疗器械都采用体内方法进行测试,这主要是由于缺乏在固体材料适用范围内经过验证的体外方法。用于评估化学皮肤致敏物质的 GARDskin 方法是一种经过验证的方法,已列入《经合组织测试指南 442E》,该方法基于对测试化学品暴露后树突状细胞样细胞中端点特异性基因组生物标记特征转录模式的评估。目前的研究旨在评估 GARDskin 的适用性,以便通过纳入 ISO 10993-12:2021 中描述的提取程序来测试固体材料,并通过测试添加了致敏剂的定制材料来证明所建议方案的功能性。结果表明,GARDskin 可与医疗器械生物测试中常用的极性和非极性萃取载体兼容。此外,在对添加了多达四种不同致敏剂的三种不同材料类型以及三种未添加致敏剂的对照材料和商业参考产品进行检测后,结果表明该方法能正确分类所有被评估的测试材料。综上所述,所提供的数据表明,GARDskin 可作为体内实验的有效替代方法,用于医疗器械的皮肤过敏评估。
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Evaluation of the applicability of GARDskin to predict skin sensitizers in extracts from medical device materials
Biocompatibility testing of medical devices is governed by the ISO 10993 series of standards and includes evaluation of skin sensitization potential of the final product. A majority of all medical devices are tested using in vivo methods, largely due to the lack of in vitro methods validated within the applicability domain of solid materials. The GARDskin method for assessment of chemical skin sensitizers is a validated method included in the OECD Test Guideline 442E, based on evaluation of transcriptional patterns of an endpoint-specific genomic biomarker signature in a dendritic cell-like cell, following test chemical exposure. The current study aimed to evaluate the applicability of GARDskin for the purpose of testing solid materials by incorporation of extraction procedures described in ISO 10993-12:2021, as well as to demonstrate the functionality of the proposed protocols, by testing of custom-made materials spiked with sensitizing agents. It was shown that GARDskin is compatible with both polar and non-polar extraction vehicles frequently used for the purpose of medical device biological testing. Further, exploring three different material types spiked with up to four different sensitizing agents, as well as three unspiked control materials and commercial reference products, it was shown that the method correctly classified all evaluated test materials. Taken together, the data presented suggest that GARDskin may constitute a valid alternative to in vivo experimentation for the purpose of skin sensitization assessment of medical devices.
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CiteScore
3.80
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0.00%
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审稿时长
13 weeks
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