The United States of America as Represented by the Secretary of

Edward P Mueller

Grace L Picciolo

David S Kaplan

A chemiluminescence method for continuously monitoring in real time the generation of oxidative products such as hydrogen peroxide and superoxide from in vitro cell-biomaterial interactions using cell lines such as Human Leukemic cells (HL-60); tumor cell line hybridomas; cells lacking the respiratory burst such as Chronic Granulomatous Disease cells as controls; Monocytic cell lines; Primary Human cells such as monocytes, pmns, fibroblasts, endothelial cells; and whole and isolated blood cells. The oxidative products have the potential for the degradation of the biomaterial and thus this information can be used to aid in predicting the functional lifetime of the biomaterial when it is used to fabricate an implanted medical device. Further, this method may be used to determine the amount of activation of biological cells which is inferred from the amount of oxidative products. This activation level aids in the determination of the degree of the inflammatory response and thus influences the degree of acceptance of the biomaterial. Thus, toxicity and biocompatability tests could be supported by these measurements.

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Bayridge, MD, United States of America

Edward P Mueller