Evaluation of the capacity of the SCGE assay to assess the genotoxicity of biomaterials.

The comet test or SCGE assay, which is already widely used in other areas, has never been used to evaluate the mutagenic potential of medical biomaterials in the final form. The purpose of our study was thus to assess the comet test as a means of assessing the genotoxic potential of finished medical biomaterials. We used silicone elastomers with increasing concentrations of 4-nitroquinoline oxide, a genotoxic agent. Hydrogen peroxide was used as the positive control, and tissue culture polystyrene as the negative control. In our study, the comet test did not detect a significant difference in genotoxicity between the pure elastomer and the same elastomer containing 0.01 mg/ml 4-nitroquinoline oxide, but did detect a significant difference between two elastomers containing 0.01 and 0.3 mg/ml of 4-nitroquinoline oxide, respectively. Since, the surface properties of the samples were identical, only the chemical composition may have caused significant differences in mutagenicity. Whatever the cause of the genotoxicity detected by the SCGE assay, testing finished biomaterials using the comet assay makes it possible to evaluate interactions between biomaterials and living tissues that are much closer to actual application conditions.