[Detailed evaluation of the agarose diffusion test in biocompatibility study with a microscopic image analysis system. Effect of plasma sterilization on biocompatible of an improved photoset polymer].

In addition to sterilizability, biocompatibility is a further necessary property of biomaterials. The agarose diffusion test is an established standard in vitro procedure for investigating this property. The usual method of evaluating the agarose diffusion test, based on macroscopic determination of the size of the zone of decoloration, and microscopic assessment of cell lysis, limits the power of the test. To obtain more information on the impact of plasma sterilization on the biocompatibility of a new polymer, a high-resolution computer-aided morphometric image analysis system for the quantification of the agarose diffusion test at the cellular level has been developed. This was able to detect statistically significant differences in the cell lysis rate of plasma sterilized polymer specimens before and after 4 weeks of incubation in a physiological solution. The new method provides highly detailed information on the interaction of soluble material elements and cells. In addition to cell damage by potentially toxic elements, the sensitivity of the L929 fibroblasts used in the agarose diffusion test to mechanical stress also needs to be considered and verified by further investigations.