In biomaterials testing, a cell culture assay is any method which is used to assess the cytotoxicity of a material. This refers to the in vitro assessment of material to determine whether it releases toxic chemicals in sufficient quantities to kill cells either directly or indirectly through the inhibition of cell metabolic pathways. Cell culture evaluations are the precursor to whole animal studies and are a way to determine if significant cytotoxicity exists for the given material. Cell culture assays are standardized by ASTM, ISO, and BSI (British Standards Institution.)
Each method has its own advantages and disadvantages, and some are more suitable for certain applications than others. For example the direct contact method offers conditions which are most similar to the physiological environment but the cells are susceptible to trauma if the material moves. The agar diffusion method is good for materials with high densities and offers an even concentration gradient for potential toxicants, but there is a serious risk of the cells going into thermal shock when they are overlaid with agar. The elution method is best for applications which might require extra incubation time, but additional time and steps are required for preparing such a test.
In vitro biomaterials testing yields fundamental information about the behaviour of materials in contact with living cells, but cannot qualify or even accurately predict the performance of a material in vivo.