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

OBJECTIVE: The purpose of this study was to evaluate the performancesof the RHE/IL-18 assay using the SkinEthicTM RHE modelfor the identification of contact sensitizers.

METHODS: A set of 18 substances and mixtures was tested onthis epidermal model, following the RHE/IL-18 protocol. The finalresults of the assay were obtained following 5 interpretationschemes, to determine the optimal prediction model for this assaywith this specific test system. The data were analysed with a specialfocus on the basal level of IL-18 release and on the performanceobtained with respect to three different gold standards: LLNA,HRIPT and an integrated reference, constructed from all availableresults.

RESULTS: No important differences were found in the performancelevels depending on the three gold standards. The performancesobtained with the SkinEthicTM RHE model support that this modelmay be considered as an alternative to different reconstructed epidermismodels (EpiDERMTM, EpiCSTM and VUMC-EE) for the performanceof RHE/IL-18 assays.

CONCLUSION: The prediction model to be used was refined, andmore substances have to be tested in order to gather enough datafor this evaluation and to determine the right criteria applicable forthis assay using the SkinEthicTM RHE test system.