[The LDH release test validated for use in assessment of the biocompatibility of Medical Devices.]
Lactaatdehydrogenase lekkage als parameter voor de bepaling van de biocompatibiliteit van medische hulpmiddelen
Machielsen JCA , Orzechowski TJH , Geffen MF van
RIVM Report 319011004
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.