Instituto Universitario Fernández-Vega, Fundación de Investigación Oftalmológica, Universidad de Oviedo, Oviedo, Spain; Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain.
Instituto Universitario Fernández-Vega, Fundación de Investigación Oftalmológica, Universidad de Oviedo, Oviedo, Spain; Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain.
Toxicol In Vitro. 2022 Aug;82:105390. doi: 10.1016/j.tiv.2022.105390. Epub 2022 May 17.
To replace the Draize eye irritation test (OECD Test Guideline 404), several test methods based on reconstructed cornea-like epithelium (RhCE) have been developed and adopted in the OECD TG 492. The objective of this study was to stablish the experimental procedures and evaluate the performance assessment of QobuR-RhCE, an in-house RhCE model to be used for the evaluation of eye hazard. We define the essential structural, functional and procedural elements of the test method components to help assuring that the proposed test method is based on the same concepts as the validated reference methods. Performance assessment was evaluated in accordance with the revised performance standards for the assessment of proposed similar or modified in vitro reconstructed human cornea-like epithelium and the minimum list of reference chemicals was evaluated. As result, the proposed method scored 93.3% sensibility, 60% specificity, 76.7% accuracy and 96.7% within-laboratory reproducibility (WLR), providing a similar performance in comparison to the validated reference methods. Additionally, we describe a secondary endpoint based on Transepithelial Electrical Resistance (TEER) that could be of use to better discriminate between irritants and non-irritants. Taken together the results indicate that the QobuR-RhCE test method is an accurate screening tool that can be used as a standalone alternative to evaluate ocular irritation.
为了替代 Draize 眼刺激试验（OECD 测试指南 404），已经开发并采用了几种基于重建的类角膜上皮（RhCE）的测试方法，该方法被纳入 OECD TG 492 中。本研究的目的是建立实验程序，并评估用于评估眼危害的内部 RhCE 模型 QobuR-RhCE 的性能评估。我们定义了测试方法组件的基本结构、功能和程序要素，以确保所提出的测试方法基于与验证的参考方法相同的概念。性能评估是根据评估提议的类似或改良的体外重建人角膜样上皮的体外重建的相似或改良的性能标准以及参考化学品的最小清单进行的。结果表明，该方法的敏感性为 93.3%，特异性为 60%，准确性为 76.7%，实验室内重复性为 96.7%，与验证的参考方法相比具有相似的性能。此外，我们描述了基于跨上皮电阻（TEER）的次要终点，这可能有助于更好地区分刺激性和非刺激性物质。总之，这些结果表明 QobuR-RhCE 测试方法是一种准确的筛选工具，可作为单独的替代方法用于评估眼部刺激。
