Preliminary performance data of the RHE/IL-18 assay performed on SkinEthic ™ RHE for the identification of contact sensitizers.

ObjectiveThe purpose of this study was to evaluate the performances of the RHE/IL-18 assay using the SkinEthic RHE model for the identification of contact sensitizers. MethodsA set of 18 substances and mixtures was tested on this epidermal model, following the RHE/IL-18 protocol. The final results of the assay were obtained following 5 interpretation schemes, to determine the optimal prediction model for this assay with this specific test system. The data were analysed with a special focus on the basal level of IL-18 release and on the performance obtained with respect to three different gold standards: LLNA, HRIPT and an integrated reference, constructed from all available results. ResultsNo important differences were found in the performance levels depending on the three gold standards. The performances obtained with the SkinEthic RHE model support that this model may be considered as an alternative to different reconstructed epidermis models (EpiDERM, EpiCS and VUMC-EE) for the performance of RHE/IL-18 assays. ConclusionThe prediction model to be used was refined, and more substances have to be tested in order to gather enough data for this evaluation and to determine the right criteria applicable for this assay using the SkinEthic RHE test system. Resume ObjectifCe travail presente l'evaluation des performances du test RHE/IL-18, realise sur le systeme d'essai SkinEthic RHE dans le but d'identifier les sensibilisants cutanes. MethodesUn ensemble de 18 substances et melanges a ete teste sur ce modele d'epiderme en suivant le protocole du test RHE/IL-18. Les resultats ont ete evalues selon 5 schemas d'interpretation pour determiner le modele predictif optimal pour ce systeme d'essai. Une attention particuliere a ete accordee a l'analyse du taux basal de relargage d'IL-18 et aux calculs de performances obtenues par rapport a trois references: LLNA, HRIPT et une reference composite prenant en compte l'ensemble des resultats disponibles. ResultatsLes performances du test obtenues avec le systeme d'essai SkinEthic n'ont pas montre de differences importantes selon les trois references utilisees, par ailleurs, l'analyse de ces performances montre que ce systeme d'essai pourrait etre considere comme une alternative a d'autres epidermes reconstruits (EpiDERM, EpiCS, et VUMC-EE) en evaluation pour la realisation du test RHE/IL-18. ConclusionLe modele de prediction a utiliser avec le systeme d'essai SkinEthic a ete ameliore. Toutefois, un nombre plus large de substances devra etre teste pour generer suffisamment de donnees afin de fixer les criteres d'interpretation adaptes a ce systeme d'essai.