Implantation of non-toxic materials from glucose sensors: evidence for specific antibodies detected by ELISA.

After subcutaneous implantation of glucose sensors into LEW.1A rats, antibodies could be detected by means of enzyme-linked immunosorbent assay against the outer membrane (cellulose acetate) but not against either the inner membrane (polyethylene) or glucose oxidase (GOD). The kinetics of humoral immune response were investigated implanting different polymeric membranes such as polyurethane, cellulose acetate, regenerated cellulose. The highest antibody titer was detected against regenerated cellulose. There was no cytotoxic effect in vitro by any of the tested materials as examined on monolayer cultures of the mouse fibroblast cell line L-929. Thus immunogenicity is suggested to be considered as a parameter in biocompatibility testing of implantable medical devices.