English Abstract In the laboratory of medicines and medical devices a
project "Biocompatibility" was initiated. The aim of the project is to
develop assays to evaluate (cyto)toxicity of medical devices and
biomaterials. In this paper the development and validation of the LDH
enzyme release test is described. This enzyme release assay was designed to
determine quantitatively the effects of extracts from medical devices and
biomaterials on cellular membrane integrity. The tissue culture agar
overlay test is still widely used and accepted as a test to measure
cytotoxicity of solid materials. The enzyme release test has been validated
with extracts of surgical gloves and non-wovens wrapping tissues used for
sterilisation. The sensitivity of the test was analysed with limiting
dilutions of cytotoxic compounds. The results were compared with the Tissue
Culture Agar Overlay test. These results were also described in this
report. Conclusion: the LDH enzyme release test is a sensitive,
reproducible and quantitative test for cytotoxicity.
