Assessment of the chorioallantoic membrane vascular assay (CAMVA) in the COLIPA in vitro eye irritation validation study
Assessment of the chorioallantoic membrane vascular assay (CAMVA) in the COLIPA in vitro eye irritation validation study
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DOI：
10.1016/s0887-2333(98)00089-7
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发表时间：
1999-04-01
影响因子：
3.2
通讯作者：
Harbell, J
中科院分区：
文献类型：
--
作者：
Bagley, DM;Cerven, D;Harbell, J
绒毛尿囊膜血管试验（CAMVA）是Draize兔眼刺激方法的替代方法。CAMVA采用受精鸡蛋的血管化膜来评估眼睛刺激潜力。该刺激潜力是供试品给药后血管系统变化的函数。由于CAMVA的使用历史，选择其作为由COLIPA组织和申办的验证研究的方法之一。对于本验证研究，开发了数学预测模型（PM），以将CAMVA结果转换为预测的Draize眼刺激评分，称为改良的最大平均Draize评分（MMAS）。将这些预测评分与观察评分进行统计学比较，以评估CAMVA的相关性。由两个独立实验室对同一组供试品进行试验。比较这两组数据，以评估试验的实验室间重现性。CAMVA的验证研究结果表明，对于MMAS在0 - 5范围或55 - 110范围内的供试材料，CAMVA没有给出良好的预测。轻度至中度刺激（MMAS 5-55）样本的预测结果更好。在刺激量表的低端预测的困难似乎是由于试验系统的生物变异性和CAMVA评价的主观性。对于MMAS高于55的样本，CAMVA似乎在证明更严重的反应方面受到限制。这可能是由于PM是使用MMAS低于该范围的试验材料的历史数据集开发的。改善眼刺激预测的CAMVA的两种方法是（1）通过减少评分中的主观性来降低低端的变异性和（2）使用严重刺激物范围内的更多数据来开发更好的预测模型。(C)1999爱思唯尔科技有限公司。保留所有权利。
The chorioallantoic membrane vascular assay (CAMVA) is an alternative to the Draize rabbit eye irritation method. The CAMVA employs the vascularized membrane of a fertile hen's egg to assess eye irritation potential. This irritation potential is a function of alterations in the vasculature following the administration of test material. Because of the history of use of the CAMVA it was selected as one of the methods for a validation study organized and sponsored by COLIPA. For this validation study mathematical prediction models (PMs) were developed to convert the CAMVA results into predicted Draize eye irritation scores known as a modified maximum average Draize score (MMAS). These predicted scores were statistically compared with the observed scores to assess the relevance of the CAMVA. The assay was conducted on the same set of test materials by two independent laboratories. These two sets of data were compared to assess the interlaboratory reproducibility of the assay. The results of this validation study of the CAMVA show that for test materials with MMASs in the 0 to 5 range or the 55 to 110 range, the CAMVA did not give a good prediction. The predictions were better for samples of mild to moderate irritation (MMAS 5-55). The difficulty in predicting at the low end of the irritation scale appears to be due to the biological variability of the test system and the subjective nature of the CAMVA evaluation. For those samples with an MMAS above 55, the CAMVA appeared to be limited in demonstrating the more severe response. This may be due to the fact that the PMs were developed using historical data sets of test materials with MMASs below this range. Two approaches for improving the CAMVA for eye irritation prediction are (1) to decrease the variability at the low end by reducing the subjectivity in the scoring and (2) to develop better prediction models using more data in the range of severe irritants. (C) 1999 Elsevier Science Ltd. All rights reserved.